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MedTech Europe

MTE

MedTech Europe represents medical technology manufacturers producing diagnostics, medical devices and digital health solutions in Europe.

Lobbying Activity

Meeting with Tiemo Wölken (Member of the European Parliament) and SPECTARIS Deutscher Industrieverband für Optik, Photonik, Analysen- und Medizintechnik e.V.

21 Jan 2026 · MDR/IVDR

Meeting with Nicolás González Casares (Member of the European Parliament)

21 Jan 2026 · Medical devices

Meeting with Dóra Dávid (Member of the European Parliament)

21 Jan 2026 · Digital omnibus

Meeting with Michele Picaro (Member of the European Parliament) and Illumina, Inc. and

20 Jan 2026 · Meeting

Meeting with Maria Pilar Aguar Fernandez (Director Research and Innovation) and

15 Jan 2026 · Exchange of views with private members of the Innovative Health Initiative Joint Undertaking (IHI-JU).

Meeting with Flora Giorgio (Head of Unit Health and Food Safety)

12 Jan 2026 · Exchange of views on the state of play of the medical devices Regulations reform proposal and follow-up on relevant events.

MedTech Europe supports chemical exemptions for medical technology components

11 Dec 2025
Topic — This initiative restricts medium-chain chlorinated paraffins under the European regulation on persistent organic pollutants.
Message — MedTech Europe supports proposed exemptions for medical device spare parts to ensure a smooth transition. They request minor wording changes and technical guidance to help manufacturers comply with new rules.12
Why — Exemptions prevent supply chain disruptions for devices requiring lengthy safety testing and validation.3
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Meeting with Jessika Roswall (Commissioner) and

4 Dec 2025 · Environmental legislation and medical technology

MedTech Europe urges continued EU investment in global diplomatic support

28 Nov 2025
Topic — EU funding for external action and international engagement in the post-2027 budget.
Message — The organization requests continued EU investment in external action, particularly supporting delegations that facilitate market access and engagement in global health organizations. They emphasize the importance of regulatory harmonization initiatives and bilateral dialogues with key trading partners.123
Why — This would maintain their access to global markets and support for European medical technology exports.456
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Meeting with Nicolás González Casares (Member of the European Parliament)

19 Nov 2025 · Medical devices

Meeting with Sirpa Pietikäinen (Member of the European Parliament)

19 Nov 2025 · One Health

Meeting with Olivér Várhelyi (Commissioner) and

18 Nov 2025 · Medical device review

MedTech Europe urges dedicated health innovation funding in EU budget

12 Nov 2025
Topic — EU's post-2027 budget framework and European Competitiveness Fund for strategic priorities.
Message — The organization requests ring-fenced health research funding, a deployment window for scaling medical technologies, and infrastructure investments for digital health systems. They seek continuation of public-private partnerships and support for SMEs navigating regulatory requirements.123
Why — This would maintain their competitive position and reduce costs of regulatory compliance and market access.456
Impact — Without dedicated health funding, patients lose access to faster innovation deployment and improved healthcare outcomes.78
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Meeting with Barry Andrews (Member of the European Parliament) and Ibec

12 Nov 2025 · MedTech

Meeting with Flora Giorgio (Head of Unit Health and Food Safety)

12 Nov 2025 · Follow-up meeting at the request of MTE to further discuss the technical input provided in the context of short-term measures and to exchange views on the upcoming MDR/IVDR reform.

MedTech Europe urges EU funding for crisis preparedness and medical countermeasures

7 Nov 2025
Topic — EU budget consultation on civil protection, health emergency preparedness and crisis response funding.
Message — The organization requests continued EU funding for agencies coordinating crisis response, joint procurement of medical countermeasures, stockpiling protective equipment and ICU systems, logistics to distribution hubs, rapid data collection systems, and research into new medical technologies. They emphasize that EU-level funding is essential because national measures only address single member states' needs.12345
Why — This would ensure their medical devices and diagnostics are procured and distributed during crises.67
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Meeting with Werner Stengg (Cabinet of Executive Vice-President Henna Virkkunen)

7 Nov 2025 · Digital Omnibus

Response to Circular Economy Act

6 Nov 2025

MedTech Europe envisions a future where healthcare systems are environmentally and financially sustainable, equitable and resilient to future crises. Building such resilient and sustainable healthcare systems requires a robust, competitive, and innovation-driven medical technology industry. The Circular Economy Act has been announced as a key component of the EUs efforts to decarbonise the economy and support industrial competitiveness. The strong focus in Europe to maintain robust social security systems and equitable healthcare access can be further enhanced by improving resource efficiency and circularity in the sourcing, production, distribution, management and disposal of medical technologies, which can reduce negative impacts on emissions, resource scarcity and biodiversity. This can be realised by leveraging a structured approach to the five Rs of Reduce, Refuse, Reuse, Renew and Recycle while maintaining sterility and patient safety. Considering that the medical technology sector represents over 2,000,000 products, services and solutions available on the Union market, and that individual devices differ greatly in terms of complexity, there is no one-size-fits-all to more circularity in the sector. It can take many different forms. To tap into its potentials, MedTech Europe calls for a Circular Economy Act that supports the following ambitions: 1) Ensuring regulatory coherence between Green Deal legislation, circularity requirements and initiatives and the sector-specific regulatory system of the Medical Devices Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. 2) Securing the free circulation of goods in the EU internal market and boosting an EU internal market for waste in support of the circular economy: Reinforcing the Single Market and the global harmonisation of standards for waste, circularity and secondary raw materials with respect to the quality and safety for patients and healthcare practitioners 3) Promoting a more sustainable pattern of production by making secondary materials more attractive. 4) Establishing a framework for financing and rewarding circularity efforts. 5) Leverage the transformation synergies of the Green and Digital agendas to increase overall system efficiencies and sustainability performance, such as dematerialisation. 6) Seeking international alignment on circularity approaches for the medical technology sector with respect to the quality and security for patients and healthcare practitioners.
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MedTech Europe urges harmonized reporting for health crisis planning

29 Oct 2025
Topic — A proposal to coordinate EU-wide responses and preparedness for cross-border health threats.
Message — MedTech Europe calls for consolidating reporting requirements for medical devices to avoid administrative duplication across different EU laws. They also advocate for industry coordination on stockpiling and the creation of rapid joint procurement mechanisms.123
Why — Harmonized rules would reduce the compliance burden on companies and prevent reporting fatigue during emergencies.45
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Meeting with Pascal Arimont (Member of the European Parliament)

16 Oct 2025 · Impact of US tariffs on medical technology companies

Meeting with Tomislav Sokol (Member of the European Parliament)

15 Oct 2025 · Health Policy

MedTech Europe urges simplification of overlapping EU digital rules

14 Oct 2025
Topic — EU digital regulations review to reduce compliance burden across sectors.
Message — The organization requests broader scope for the Digital Omnibus to align all digital laws, provide clear guidance on conflicting requirements, and harmonize implementation across Member States. They seek targeted alignment between the AI Act and sectoral frameworks to avoid duplicate conformity assessments and overlapping obligations.1234
Why — This would reduce compliance costs and enable faster market access for innovations.567
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MedTech Europe urges streamlined EU medical device regulations

6 Oct 2025
Topic — EU proposal to simplify medical device and in vitro diagnostic regulations.
Message — The organization requests a single governance structure, risk-based conformity assessment, and removal of duplicative requirements. They advocate for simplified pathways for low-risk devices and accelerated approval for breakthrough innovations. They also seek unlimited certification validity and broader use of real-world data for clinical evidence.1234
Why — This would reduce lifecycle costs and provide greater planning certainty for investment.5
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Meeting with Chiara Galiffa (Cabinet of Commissioner Maroš Šefčovič) and Johnson Johnson and

25 Sept 2025 · EU – US relations

Meeting with Saila Rinne (Head of Unit Communications Networks, Content and Technology)

23 Sept 2025 · AI in health.

Meeting with Laurent Castillo (Member of the European Parliament)

23 Sept 2025 · cardiovasculaire

Meeting with Olivér Várhelyi (Commissioner) and

23 Sept 2025 · Preparation for the upcoming EU Cardiovascular Action Plan

Meeting with Patricia Reilly (Cabinet of President Ursula von der Leyen)

23 Sept 2025 · EU Cardiovascular Health Plan & Medical Devices Regulation (MDR)

Meeting with Victor Negrescu (Member of the European Parliament) and FTI Consulting Belgium and

23 Sept 2025 · Meeting with MedTech Europe Cardiovascular Sector Group

Response to EU cardiovascular health plan

17 Sept 2025

MedTech Europe welcomes the Commissions development of an EU Cardiovascular Health Plan to tackle the main cause of death in the EU: cardiovascular diseases (CVD), including stroke. Some 60 million Europeans live with CVD. CVD risks are 2-3 times higher for people with diabetes, with obesity being a major driver. Sleep disorders are also a major risk factor. The EU Cardiovascular Health Plan is a key opportunity to address the CVD health challenge. MedTech Europe share the Commissions clear and measurable objective for the Plan, namely reducing premature and preventable CVD deaths and disability in the EU by 30% by 2030, aligning with UNSDG 3.4. The Commissions announced priorities: optimising patient pathways from detection to treatment, data-driven decision-making, accelerating access to innovation, and reducing inequalities across Member States, marginalised communities and genders, require swift action. We urge the Commission to allocate EUR 5 billion over 5 years, strategically leveraged across multiple EU instruments, a sum representing < 2% of the total economic burden of EUR 282 billion imposed annually by CVD. We strongly endorse the key role envisioned for medical technologies as lifesaving and life-improving innovations that enhance patient outcomes and alleviate pressured healthcare systems. We recognise the Commissions intention to help make the health and medical technology industry more competitive, delivering significant value by enabling earlier diagnosis, personalised interventions and more efficient prevention and provision of care for patients of all ages and suffering from all types of CVD, including stroke, heart failure, atrial fibrillation, structural heart disease, and vascular disease. Medical technologies and solutions are vital to treat and prevent CVD, relieving health systems and delivering on the EUs vision for a healthier Europe, given their proven cost-effectiveness. To ensure the plan delivers impactful results, we call upon the Commission to include the following recommendations: Establish a Cardiovascular Health Check Programme for systematic early detection and precision diagnosis of key risk factors such as blood pressure, glucose, cholesterol levels, diabetes, BMI, PAD, and enable age-appropriate risk assessments. Ensuring the uptake of innovative medical technologies, including AI, in a cardiovascular health check programme can facilitate timely interventions for risk factors among citizens with undiagnosed CVD. For example, remote monitoring using built-in algorithms of implanted devices helps early diagnosis in case of disease progression and must be part of disease management. Set up an EU Network of Centres of Excellence to strengthen clinical excellence, ensure improved, timely patient care, foster R&I, learning from Europes Beating Cancer Plan experiences, and in line with the EU Life Sciences Strategys goals. Coordinated, multidisciplinary care models, supported by interoperable health data, are essential to break down silos and improve outcomes. The network must develop guidelines for optimal CVD and stroke pathways and a quality assurance scheme to ensure coordinated, evidence-based care, addressing inequalities. Support evidence-based decision-making through a Cardiovascular Health Knowledge Centre to accelerate the deployment of existing and new cardiovascular and stroke registries. The centre would also harmonise data within the EHDS and identify gaps to address inequalities. Accelerate access to innovation by implementing tailored actions from early evidence that reward long-term value as part of procurement processes, accelerated regulatory pathways, and funding and reimbursement models, to ensure patients and healthcare systems can access existing and breakthrough innovations. The Plan must set clear targets, accompanied by a robust governance framework and a dedicated budget. Supporting materials: MedTech Europe Cardiovascular Sector Groups policy proposals
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Meeting with Lucilla Sioli (Director Communications Networks, Content and Technology)

4 Sept 2025 · Implementation of the AI Act

MedTech Europe urges holistic EU climate resilience framework

3 Sept 2025
Topic — This consultation addresses accelerating climate risks and the need for an integrated management framework.
Message — MedTech Europe calls for a comprehensive framework that aligns with existing medical device regulations. They recommend creating a High-Level Group to facilitate strategic dialogue between industry and policymakers.123
Why — This approach would protect supply chains and ensure regulatory consistency for medical device manufacturers.45
Impact — Non-EU manufacturers using high-carbon energy sources would lose their competitive price advantage.6
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Response to Revision of the 'New Legislative Framework'

2 Sept 2025

MedTech Europe welcomes the opportunity to provide input to the European Commissions Call for Evidence for the revision of the New Legislative Framework. MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health. Our members are national, European and multinational companies as well as a network of national medical technology associations that research, develop, manufacture, distribute and supply health-related technologies, services and solutions. Please find attached our detailed input.
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Meeting with Peter Liese (Member of the European Parliament) and Stegra (formerly H2GS AB) and Impossible Foods

28 Aug 2025 · Austausch

MedTech Europe warns against carbon border tax for medical devices

25 Aug 2025
Topic — Extending the Carbon Border Adjustment Mechanism to include downstream steel and aluminium products.
Message — MedTech Europe requests that medical devices and their specific metal components be excluded from the expanded carbon tax scope. They argue that the current proposal imposes unfeasible administrative burdens on highly complex supply chains while offering no evidence of carbon leakage.12
Why — The industry would avoid massive reporting costs that can be a hundred times higher than the carbon tax.3
Impact — European patients may lose access to life-saving equipment due to supply delays and increased healthcare system costs.4
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MedTech Europe demands exemptions from unsold textile destruction ban

6 Aug 2025
Topic — Proposal to define exemptions for the ban on destroying unsold apparel products.
Message — MedTech Europe requests that medical technologies be exempt from the ban on destroying unsold clothing and footwear. They argue that specific safety regulations must prevail over waste rules for health reasons.12
Why — Exemptions would shield manufacturers from penalties and legal liability for distributing non-compliant or expired equipment.3
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Meeting with Maya Matthews (Head of Unit Health and Food Safety) and European Coordination Committee of the Radiological, Electromedical and healthcare IT Industry

24 Jul 2025 · Discuss the input received during the public feedback on the draft Implementing Regulation on joint clinical assessments for medical devices and in vitro diagnostic medical devices

Response to Revision of the Standardisation Regulation

21 Jul 2025

Regulation (EU) 1025/2012: Impact, Effectiveness, and Future Improvements Regulation (EU) 1025/2012 is a crucial component of the New Legislative Framework, particularly impactful in the healthcare sector. MedTech Europe strongly endorses this regulation because European harmonized standards are vital. They ensure products meet essential requirements and establish a presumption of conformity with EU harmonization legislation. The regulation has moderately achieved its objectives. It successfully aimed to streamline the standardization process for Commission-requested standards and enhance the representation of SMEs and societal stakeholders within this process. Furthermore, it worked to expand the adoption of ICT standards to improve interoperability in the European public procurement market. Finally, it clarified ambiguities by consolidating three previous overlapping legal instruments governing EU standardization (Decisions 87/95/EEC, 1673/2006/EC, and Directive 98/34/EC). MedTech Europe supports maintaining the current regulation, as most challenges stem from its implementation rather than its inherent design. Any revision should only occur if a thorough impact assessment justifies it. While guidance like MDCG 2021-5 rev1 on medical device standardization is appreciated, there is a clear need for greater transparency regarding HAS consultant timelines and harmonization overall. Regulation (EU) 1025/2012 should also leverage broader engagement, not only with standardization bodies such as ISO, CEN, and CENELEC but also with the regulators directly impacted by these harmonized standards. The success of the European standardization system relies on the extensive participation of experts from all stakeholder groups. Key Areas for Improvement in the Regulation's Revision While we generally support the underlying principles of the regulation and do not see the need for major revisions, we do wish to highlight crucial areas for improvement: A primary concern is the limited number of available harmonized standards, especially under the Medical Device Regulation (MDR). Despite their legal significance as EU law, providing a presumption of conformity that greatly simplifies compliance for medical device manufacturers, very few have been harmonized even eight years after the MDR's entry into force, a stark contrast to previous directives or other sectors. Accelerate the work of standardization bodies: European organizations like CEN and CENELEC, along with international bodies such as ISO and IEC, form the backbone of standardization due to their established structures and technical expertise. The Commission should prioritize entrusting standardization projects to these institutions and actively support national standards organizations within EU member states. Critically, the efficiency of these bodies and their international cooperation must be urgently strengthened, by identifying and resolving the root causes of persistent delays in standardization projects, as observed, for instance, with the AI Act, to ensure timely and high-quality outcomes, thereby allowing standardization to make its vital contribution. Clarification of the hierarchy among harmonised, non-harmonised, and guidance documents under the MDR/IVDR is crucial. Situations often arise where the hierarchy among harmonised standards, MDCG guidances, and non-harmonised international standards which frequently represent the current state-of-the-art is unclear. As outlined in Standardisation Regulation 1025/2012, standardisation contributes to the functionality of the internal market and plays a vital role in international trade. However, harmonisation of standards is a strictly European concept. A European standard is developed based on a standardisation request (e.g., M/575) from the European Commission, aiming to provide a presumption of conformity with legal provisions. Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on
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MedTech Europe urges medical sector exemptions from EU Data Act

18 Jul 2025
Topic — This consultation explores streamlining EU data rules through a Data Union Strategy.
Message — The association urges making Data Act sharing obligations voluntary for medical technology companies. They want the sector-specific European Health Data Space to be the primary framework. They also seek to delay implementation until 2029.123
Why — This would reduce regulatory costs and protect the industry's sensitive technical secrets.4
Impact — External software developers lose access to raw data generated by medical devices.5
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Meeting with Werner Stengg (Cabinet of Executive Vice-President Henna Virkkunen)

18 Jul 2025 · Artificial Intelligence

MedTech Europe seeks exemption from unsold product disclosure rules

10 Jul 2025
Topic — The EU is setting disclosure rules for companies that destroy unsold consumer products.
Message — MedTech Europe requests that medical devices be exempt from disclosure requirements. They argue that existing sector laws should take precedence over these rules. Specific health and safety needs justify a derogation from these reporting obligations.12
Why — This would prevent companies from facing duplicative administrative burdens and additional financial costs.3
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Meeting with Marco Marsella (Director Health and Food Safety) and European Federation of Pharmaceutical Industries and Associations and

10 Jul 2025 · EHDS and IHI calls

Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur) and European Healthcare Distribution Association

1 Jul 2025 · Health policy

Meeting with Sandra Gallina (Director-General Health and Food Safety) and

30 Jun 2025 · Cardiovascular health and the EU Medical Devices legislation

Meeting with Sandra Gallina (Director-General Health and Food Safety) and

24 Jun 2025 · Exchange of views on the state of play and next steps for the medical devices sector.

Meeting with Sandra Gallina (Director-General Health and Food Safety) and

24 Jun 2025 · EU medical device regulation and policy.

Meeting with Ekaterina Zaharieva (Commissioner) and

23 Jun 2025 · Life sciences

Meeting with Patricia Reilly (Cabinet of President Ursula von der Leyen)

20 Jun 2025 · TO FOLLOW

Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

20 Jun 2025 · US Tariffs - EU Trade countermeasures

Meeting with Patricia Reilly (Cabinet of President Ursula von der Leyen)

20 Jun 2025 · Medical technology tariffs and trade

Response to Establishment of an expert panel on orphan and paediatric devices

13 Jun 2025

MedTech Europe welcomes the expansion of the expert panels' scope to include a dedicated panel for paediatrics and rare diseases. We understand that the panels remit is to cover both medical devices and in vitro diagnostic devices (IVDs), and we suggest this be clearly stated in the implementing decision, ensuring the inclusion of experts in both areas. We also propose adding the term rare clinical use to the new panels description to reflect devices used in special clinical situations, including for common diseases, where their use is not systematic but remains critical. Overall this is a very welcome initiative, especially in light of the serious challenges posed by MDR and IVDR implementation, which have already contributed to the discontinuation of life-saving devices across multiple areas of healthcare, particularly in low-volume or high-need contexts such as paediatrics and rare diseases.
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MedTech Europe calls for biotech funding and regulatory simplification

11 Jun 2025
Topic — European Commission initiative to accelerate biotechnology transition from laboratory to the market.
Message — MedTech Europe recommends increased investment in research hubs and prioritized funding for medtech innovations. They call for regulatory simplification and fast-track pathways to prevent delays for patients. Furthermore, they support procurement models reflecting broad public health benefits.12
Why — Proposed regulatory simplification would lower market entry barriers and decrease operational compliance costs.34
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Meeting with Olivér Várhelyi (Commissioner) and

10 Jun 2025 · Competitiveness of the European medical devices industry

Meeting with Marc Lemaitre (Director-General Research and Innovation) and European Federation of Pharmaceutical Industries and Associations and

4 Jun 2025 · 2nd dialogue with representatives from across the life sciences to review the progress of the IHI, to discuss opportunities to optimise the current partnership and to exchange views on the future of EU research and innovation programmes.

Meeting with Denis Redonnet (Deputy Director-General Trade) and

4 Jun 2025 · In his mission letter Commissioner Maroš Šefčovič is tasked to “closely monitor the full enforcement of our trade agreements on market access and rules […]”.

Meeting with Flora Giorgio (Head of Unit Health and Food Safety)

27 May 2025 · MDR/IVDR

Response to Communication on the EU Stockpiling Strategy

9 May 2025

MedTech Europe response to EC Call for Evidence on the EU Stockpiling Strategy Emergency preparedness is a public health imperative, and stockpiles are a cornerstone of a holistic approach to strengthening preparedness strategies. The COVID-19 pandemic has proven that Member States capabilities to purchase, stock, and distribute healthcare products are limited. Strengthening stockpiles at national and EU levels will prove essential for any future public health emergencies, whether pandemic, technogenic or environmental event. Effective and sustainable stockpiling of medical technologies should focus on ensuring the availability of needed devices and services all along the continuum of care, where needed for patients and at any (unforeseeable) place and point in time. The following principles should be considered: The medical technology industry has well-established processes for the storage and distribution of medical goods and, therefore, can be a strong partner to ensure future effective stockpiling. A comprehensive stockpiling system in Europe should be based on stockpiling at the national level and be complemented at the EU level. Stockpiling would be based on Member States needs and capacities, and the EU can play a crucial role in coordinating and aligning the scope and quantities at all phases (from production to deployment, including period reviews). Different disciplines, such as procurers and epidemiologists, should be involved in the definition of the scope of equipment to be stockpiled. Periodic reviews and dynamic use of stockpiles ensure that the equipment stored is not thrown away when it expires and is always ready to use. Based on the lessons learnt from Joint Procurement Framework, new purchasing models are to be explored through new partnership agreements that can reflect the need for continuous stock flow. As stockpiling means increased costs, more sustainable financial instruments for stockpiling should be created in the long run, beyond the seven-year cycles of the EU Multiannual Financial Framework. An optimum system should combine a mix of physical and virtual stockpiling. Stockpiling life-cycle management is crucial to ensure the financial sustainability of the program. Dedicated digital solutions and infrastructures are required. Stockpiling procedures must be consistent with the internal market procedures and should consider both upstream and downstream supply chain factors to avoid disruptions and manufacturing shortages. Having a list of critical medical countermeasures subject to stockpiling requirements is essential. Synergies between different public health threat scenarios should be taken into account, as medical equipment stockpiles may respond to multiple needs for disaster response.
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Response to EU Strategy on medical countermeasures

9 May 2025

MedTech Europe response to EC Call for Evidence on the EU Strategy for Medical Countermeasures Medical technology (medical devices, in vitro diagnostics (IVDs) and digital health solutions) plays a crucial role in healthcare systems worldwide and is essential for addressing any public health threats in Europe. During COVID-19, the medical technology sector was at the forefront of emergency response, from the detection and monitoring of cases to the protection of healthcare personnel and the saving of lives in intensive care units (ICU). The pandemic has exposed the limitations of national-level response measures and shown the complexity of the supply chains. A strategy to support medical countermeasures (MCM) is pivotal for effectively addressing public health threats. A clear definition of the desired outcomes and ways to achieve them, given the means available, will be essential. The complexity of the supply chains and the impossibility of autonomy make international cooperation and partnerships an important part of the MCM strategy. The following points should be considered: The different natures of public health threats require different approaches in preparedness (e.g., stockpiling personal protective equipment (PPE)) and the emergency phase (e.g., tailored IVD solutions). Correct application of medical technology can be instrumental in preventing public health emergencies. Diagnostics and testing infrastructure play a crucial role in threat detection and monitoring, as well as in speeding and maximising response efficiency. An adequate normative framework is required to support the availability and launch of new MCMs, especially in the case of public health emergencies. The regulatory burden for research and development and validation substantially delays the launch of products in the EU, increases their healthcare system costs, and undermines industry competitiveness. Research and innovation are key to delivering suitable, effective and efficient MCM for crisis response. Digital infrastructures are essential to ensuring patients` access to healthcare solutions and effectively monitoring supply, demand, and current stock of MCM. The ICU environment will be crucial to care for critically ill patients in any type of public health emergency, and its availability and adequacy must be a priority. PPE is an integral element of the emergency response. Mechanisms for effective and timely training of healthcare personnel and patients on the use of MCMs should be devised. In the case of global medical technology supply chains, both upstream and downstream factors must be considered in the strategy. Self-sufficiency is impossible in the case of a public health emergency, so solidarity mechanisms and external partnerships are required to ensure the timeliness and availability of assistance. The price should not be the de facto sole or primary criterion of the Member States or EU procurement mechanisms. SMEs and midcap companies play an important role in driving innovation and specialised manufacturing in the medical technologies sector, ensuring availability of MCMs.
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Meeting with András Tivadar Kulja (Member of the European Parliament)

24 Apr 2025 · US-EU trade in medical sector

MedTech Europe Demands Structural Reform of EU Medical Regulations

17 Apr 2025
Topic — The EU strategy aims to boost competitiveness and innovation across life sciences.
Message — The association demands a structural reform of the medical device regulatory system by 2026. They request simpler rules across digital and environmental policies to reduce the cumulative regulatory burden. Finally, they seek strategic funding to modernize European healthcare infrastructure and research.123
Why — Streamlined regulations would lower compliance costs and speed up the launch of innovations.45
Impact — Environmental standards could be weakened by efforts to simplify chemical and packaging laws.6
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Meeting with Oliver Schenk (Member of the European Parliament)

11 Apr 2025 · European Medtech

Meeting with Stéphane Séjourné (Executive Vice-President) and

10 Apr 2025 · Impact of US tariffs

Meeting with Kerstin Jorna (Director-General Internal Market, Industry, Entrepreneurship and SMEs) and

10 Apr 2025 · Impact of US tariffs

Meeting with Andreas Glück (Member of the European Parliament)

27 Mar 2025 · Medical Devices

Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

20 Mar 2025

MedTech Europe welcomes the European Commissions targeted evaluation of EU rules on medical devices and in vitro diagnostic medical devices. Ensuring delivery of healthcare to patients and competitiveness of the medical technologies industry which delivers the medical devices and diagnostics to our healthcare systems is crucial. There is a broad consensus that current regulatory framework is unpredictable, complex, slow and costly thus hampering competitiveness and innovation. New/innovative devices and devices already on the market currently struggle to reach European patients and health systems. Policymakers and stakeholders need to act decisively now to address this situation. -/- The European Commission should develop a package of legislative reforms for IVDR and MDR by latest early-2026 to ensure that these regulations deliver on their original objectives. The improved regulatory systems should be more efficient, innovation-friendly and well-governed while providing a high level of product safety and performance. Also, immediate targeted measures are needed to support device availability and the viability of the medical technology industry. The immediate targeted measures should reduce the initial assessment times and costs and make them more predictable, make change control more efficient, establish a pathway for breakthrough innovation, and adapt certificate validity to follow the device lifetime. The targeted evaluation should identify solutions swiftly which should be acted upon through implementing acts and other tools, like guidance, or included in the reform packages for IVDR and MDR. -/- MedTech Europe has compiled a library with evidence, papers and reflections to contribute to the assessment and identification of issues and solutions, which can be accessed via the link provided in the attachment to this Call for Evidence. -/- In short, the areas where action is needed are: 1) Efficient regulatory system. It is important that the system is predictable, risk-based and promote a least-burdensome approach for pre- and post-market assessment. A net reduction in complexity and cost is essential: the system should be lean, pragmatic and able to react and adapt to changes. MedTech Europe has collected data on regulatory burden and prepared an extensive Report on Administrative Burden under IVDR & MDR on the areas where unnecessary burden can be simplified or eliminated (the links to these reports are provided in the attachment). 2) Innovation-friendly regulatory system. The regulatory framework needs to be reviewed to identify the improvements necessary to support bringing innovative medical technologies to the EU market. The European Commission should adopt policies that better support innovation as part of its reforms of MDR and IVDR, including ensuring a predictable and efficient certification process and assessment of new innovations and optimisation of existing technologies. Cutting the red tape to free up the resources will also allow manufacturers to invest in new technologies and optimization activities. There is a need to establish a rapid regulatory pathway for breakthrough innovation, early dialogue on clinical evidence strategies and more efficiency in change control. The MedTech Europe 2024 Regulatory Survey Report has a dedicated section on innovation showing the impact of IVDR and MDR on innovation activities. 3) A well-governed regulatory system. The current multilayered governance system has shortcomings that impact the effectiveness of the CE-marking process and the timely availability of devices for patients and health systems as well as the competitiveness of the medical technology sector in Europe. Those challenges can be overcome by centralising key tasks and responsibilities under a future governance structure. MedTech Europe, together with AESGP, COCIR, EEAR, EUROM and FIDE, has published a paper on this topic (the link to this paper is provided in the attachment).
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Response to Implementing regulation for electronic instructions for use for medical devices

20 Mar 2025

MedTech Europe warmly welcomes the European Commissions proposal for the update of the EU Regulation 2021/2226 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices. This is a move in the right direction as electronic instructions for use (eIFU) will improve accessibility, searchability and adaptability for professional users of medical devices. The possibility to provide eIFU for all professional use medical devices will also greatly contribute to reduction of paper waste and help manufacturers streamline their process and supply their devices faster. The user will always have the most up-to-date version of the IFU. Looking towards the future, in the fast-changing digitalisation landscape, a more eco-friendly, paper-free, and efficient healthcare environment is imperative. Further digitalisation is crucial for increasing Europes competitiveness, streamlining processes and reducing administrative burden of both EU Regulations for medical devices (MDR) and in vitro diagnostics (IVDR). For the medical device sector, further digitalisation initiatives need to be envisaged, such as eIFU for lay users (particularly where the lay user is trained by a professional). For the IVD sector, MedTech Europe calls for expanding eIFU to all professional use IVDs, including devices intended for near-patient testing. We would like to urge a start of such discussions in the Medical Devices Coordination Group (MDCG) as soon as possible; in line with the overall broader ambition around EU goals of competitiveness, simplification, digital transformation, and sustainability. We have made a few concrete comments on the current draft, which you will find outlined in the attachment to this consultation.
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Meeting with Flora Giorgio (Head of Unit Health and Food Safety)

13 Mar 2025 · Meeting requested in preparation ahead of the upcoming Medical Device Coordination Group (MDCG) on 2-3 April and the MedTech Forum in May.

Meeting with Rainer Becker (Director Health and Food Safety) and

10 Mar 2025 · Exchange of views on the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)

MedTech Europe urges EU to end price-only healthcare tenders

6 Mar 2025
Topic — The EU is evaluating directives governing public procurement and concession contracts.
Message — MedTech Europe requests a ban on price-only contract awards to better reflect the value of medical innovations. They also want mandatory market consultations and more flexible, innovation-friendly bidding procedures.123
Why — Shifting away from price-only tenders protects manufacturers from aggressive cost-cutting competition.4
Impact — Public authorities lose flexibility to prioritize low costs when managing tight healthcare budgets.5
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Response to Unique Device Identifiers for spectacle frames, spectacle lenses and ready-made reading spectacles

27 Feb 2025

MedTech Europe, the European trade association representing the medical technology industry, recognizes and acknowledges the goals of a global UDI system and therefore opposes the proposed delegated act on Master UDI-DI. Main concern: Europe departs from a global IMDRF-approach on UDI which comes with a long list of disadvantages, for the Regulators, the Economic Operators, and the Patients. MedTech Europe would like to remind the co-legislators on the foundation of the UDI system used in various jurisdictions around the world including Europe based on the principles established by the International Medical Device Regulators Forum (IMDRF): "The UDI system is intended to provide a single, globally harmonized system for positive identification of medical devices. Healthcare professionals and patients will no longer have to access multiple, inconsistent, and incomplete sources in an attempt to identify a medical device and, its key attributes. [] " MedTech Europe wishes to contribute to the public consultation with the following arguments: 1 - The European Union departs from the global concept being the only jurisdiction proposing to implement the Master UDI-DI as a regulatory solution. 2 - The UDI-DI for devices with a high number of variants will no longer identify the type of device uniquely. The concept is being expanded beyond contact lenses, but the consequences are not yet understood. 3 - The regulatory concept of Master UDI-DI will compromise logistical and supply chain processes. 1 - The EU regulators decide to implement a regulatory rather than a database/technical solution to manage UDI data for devices with a high number of variants. The integrity, consistency, granularity, structure, and governance of these device is being diverted in the European UDI system (independently from the UDI system established in the rest of the world) rather than implementing a technical solution in EUDAMED. This is a disadvantageous departure from the global UDI-system. Moreover, industry believes that in Europe the practical consequence of the technical challenge (in either way, holding a high number of UDI-DIs or handling a separate identifier like the Master UDI-DI) in EUDAMED has not been investigated in sufficient depth to arrive at the conclusion that a Master UDI-DI is the preferable solution. 2 - The current UDI system as described by IMDRF and utilized by many other regulators globally, provides the ultimate granularity for the unambiguous identification of devices by assigning a globally unique device identification number for a device which relates to all available technical parameters. Homogenizing previously unambiguously identified devices into a high-level Master UDI-DI that then relies on a combination of single parameters will lead to loss of detail and identification which needs to be introduced elsewhere to comprehend the uniqueness of a device. 3 - The requirement to assign a Master UDI-DI and place an enlarged UDI-carrier on the label is counterproductive since neither the Economic Operators in the supply chain (mostly retail) nor the users are currently able to read the barcode and to process its content. This results in drawbacks regarding patient safety, manufacturing and supply chain processes, and disconnection from the rest of the world UDI system (and therefore, further depart from IMDRF guidelines). It has severe implication to the identification of one and the same type of device globally, its traceability and the collection of post-market data for such type of device. Last but not least, a requirement for a local label will have consequences for the attractiveness of the market which requires it and the price the patient will have to pay for such device.
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MedTech Europe Urges Exclusion From Critical Medicines Act

27 Feb 2025
Topic — The initiative addresses supply chain vulnerabilities and reduces Europe’s dependencies on critical medicines.
Message — MedTech Europe recommends that medical technologies remain excluded from the Critical Medicines Act. They argue that solutions effective for pharmaceuticals are not applicable for medical devices.12
Why — This would prevent the imposition of unsuitable pharmaceutical regulations on their complex supply chains.34
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Meeting with Gabriela Tschirkova (Cabinet of Commissioner Valdis Dombrovskis)

12 Feb 2025 · Innovation in medical technologies and reform of regulatory framework

Meeting with Arthur Corbin (Cabinet of Executive Vice-President Stéphane Séjourné), Vilija Sysaite (Cabinet of Executive Vice-President Stéphane Séjourné)

10 Feb 2025 · Clean Industrial Deal, Medical Device Regulation, Public Procurement, REACH

MedTech Europe urges longer lead exemption transition periods

7 Feb 2025
Topic — EU consultation on time-limited exemptions for lead in electrical and electronic equipment components.
Message — The organization requests 18-month transitional periods for categories 8 and 9 medical technologies, at least 2 years additional renewal time compared to other product categories, and fall-back mechanisms for applications not captured in new sub-entries. They argue current 12-month timelines are insufficient given complex supply chains and medical device requalification requirements.1234
Why — This would give manufacturers more time to source alternatives and requalify products under medical device regulations.567
Impact — Patients lose access to diagnostic and treatment technologies if devices become obsolete without viable alternatives.8910
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MedTech Europe urges extended timelines for lead exemption phase-out

7 Feb 2025
Topic — EU regulation restricting lead in electrical components used in medical devices.
Message — The organization requests 18-month transitional periods for medical device categories and at least 2 additional years for exemption renewals compared to other sectors. They argue current 12-month timelines are insufficient given the complex multi-tier supply chain and stringent medical device requalification requirements.123
Why — This would prevent premature discontinuation of medical devices and allow time to requalify products under EU medical technology legislation.45
Impact — Patients lose access to diagnostic tests and medical devices if manufacturers cannot source compliant components in time.67
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MedTech Europe urges extended lead exemption transition periods

7 Feb 2025
Topic — EU consultation on lead restrictions in electrical and electronic medical equipment.
Message — The organization requests 18-month transitional periods for categories 8 and 9 medical technologies, at least two additional years for exemption renewals compared to other product categories, and a fall-back mechanism for applications not captured in new sub-entries. They argue current 12-month timelines are insufficient given complex supply chains and requalification requirements under medical device regulations.123
Why — This would prevent market discontinuation of medical technologies and give manufacturers time to requalify products under stringent sectoral requirements.456
Impact — Patients and healthcare facilities lose access to diagnostic tests and medical devices if equipment becomes prematurely obsolete.78
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MedTech Europe Demands Urgent Reform of Fragmented Medical Regulations

31 Jan 2025
Topic — This consultation aims to remove barriers and enhance the European Union's single market.
Message — MedTech Europe calls for a "package of legislative reforms" for medical device regulations to improve governance. They request the "preferred adoption of Regulations over Directives" to prevent fragmented national interpretations. Finally, they urge better "synchronisation across policy domains" to avoid conflicting legal requirements.123
Why — A unified market would help medical technology companies "streamline operations and reduce costs."45
Impact — Patients and healthcare systems suffer as "innovation now reaching European citizens later" than elsewhere.67
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Meeting with Flora Giorgio (Head of Unit Health and Food Safety)

30 Jan 2025 · Regulatory Affairs Committee on Medical Devices (RAC MD) of MedTech Europe (MTE) - Day 2

Meeting with Lena Schilling (Member of the European Parliament)

3 Dec 2024 · emissions and circular economy for medical technology

Meeting with Nicolás González Casares (Member of the European Parliament)

19 Nov 2024 · Health

Meeting with Tomislav Sokol (Member of the European Parliament) and Novartis International AG and

19 Nov 2024 · Health policy

Meeting with András Tivadar Kulja (Member of the European Parliament)

24 Oct 2024 · Medical devices regulation

Meeting with Victor Negrescu (Member of the European Parliament) and European Federation of Pharmaceutical Industries and Associations and

16 Oct 2024 · European Health Policies and their Impact on CEE Countries and Romania event

Meeting with Ana Vasconcelos (Member of the European Parliament)

14 Oct 2024 · medical technology industry

Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

11 Oct 2024 · MDR

Meeting with Oliver Schenk (Member of the European Parliament)

9 Oct 2024 · medical technology industry

Meeting with Tiemo Wölken (Member of the European Parliament)

9 Oct 2024 · Exchange on MDR/IVDR (staff level)

Meeting with Nicola Zingaretti (Member of the European Parliament)

9 Oct 2024 · Medical Industry and packaging

Meeting with Elena Donazzan (Member of the European Parliament) and L'Oréal

9 Oct 2024 · Incontro conoscitivo e scambio di vedute sul mandato del Parlamento Europeo

Meeting with Gheorghe Piperea (Member of the European Parliament)

9 Oct 2024 · Challenges in the medical technology industry

Meeting with Daniel Attard (Member of the European Parliament)

9 Oct 2024 · Priority Topics for MedTech

Meeting with Victor Negrescu (Member of the European Parliament)

8 Oct 2024 · European medical technology sector and EU policies in the field

Meeting with Ingeborg Ter Laak (Member of the European Parliament)

8 Oct 2024 · Medical devices

Meeting with András Tivadar Kulja (Member of the European Parliament)

8 Oct 2024 · Medical devices

Meeting with Tomislav Sokol (Member of the European Parliament)

10 Sept 2024 · Future of digital policies impacting health

Meeting with Mairead McGuinness (Commissioner) and

10 Sept 2024 · High-level executive roundtable: preventing the circumvention of EU sanctions on sensitive goods.

Meeting with Valdis Dombrovskis (Executive Vice-President) and BUSINESSEUROPE and

10 Sept 2024 · Preventing the circumvention of EU sanctions on sensitive goods

MedTech Europe seeks extended transition periods for UV-328 phase-out

23 Aug 2024
Topic — EU regulation restricting UV-328, a persistent organic pollutant used in medical devices.
Message — The organization requests extended transition periods of 5-10 years for medical technology applications not covered by existing derogations. They argue that modifications to medical device chemical composition trigger stringent regulatory requirements under MDR/IVDR, including validation, clinical testing, and updates to certifications.123
Why — This would give them more time to comply while avoiding costly immediate redesigns of certified medical devices.4
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MedTech Europe urges EU to include spare parts exemptions for Dechlorane Plus

18 Jul 2024
Topic — EU regulation implementing Stockholm Convention restrictions on Dechlorane Plus chemical substance.
Message — The organisation requests the Commission amend its regulation to include derogations for medical device and IVD replacement parts, matching exemptions already adopted in the Stockholm Convention. They emphasise the EU must remain consistent with international exemption decisions to avoid regulatory fragmentation.12
Why — This would allow continued use of Dechlorane Plus in spare parts for medical devices and diagnostics.34
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Meeting with Marc Lemaitre (Director-General Research and Innovation)

19 Apr 2024 · Exchange of views on Innovative Health Initiative (IHI JU)

Meeting with Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides), Ralf Kuhne (Cabinet of Commissioner Stella Kyriakides) and

11 Apr 2024 · Meeting with representatives from the Medtech Europe Cardiovascular sector group.

Meeting with Birgit Sippel (Member of the European Parliament)

26 Mar 2024 · European Health Data Space (Staff-level)

MedTech Europe urges clearer safeguards in EU chemicals reform

4 Mar 2024
Topic — Proposal to streamline chemical safety assessments across EU legislation under ECHA.
Message — The organization requests that ECHA receive adequate funding and expertise for new responsibilities, formal impact assessment of resource needs, and protection of confidential business information. They seek clarification on the interface between REACH and RoHS, and opportunities to shape implementation of the One Substance One Assessment approach.12345
Why — This would reduce regulatory uncertainty and protect proprietary information from competitors.678
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MedTech Europe urges ECHA funding and expertise safeguards in chemicals reform

4 Mar 2024
Topic — EU proposal to streamline chemical assessments and create common data platform.
Message — The organization requests clarifications to optimize the legislative proposals, including ensuring ECHA has necessary expertise in medical devices, carrying out a formal Impact Assessment for additional resources, and providing adequate funding. They emphasize the need to streamline existing databases and clarify the interface between REACH and RoHS.12345
Why — This would prevent delays and maintain legal certainty in the medical device exemption process.67
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Meeting with Birgit Sippel (Member of the European Parliament)

27 Feb 2024 · European Health Data Space (Staff-level)

Meeting with Tiemo Wölken (Member of the European Parliament, Shadow rapporteur)

29 Jan 2024 · MDR and IVDR Urgency (staff level)

Meeting with Giorgos Rossides (Cabinet of Commissioner Stella Kyriakides), Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

5 Dec 2023 · Exchange of views with MedTech on the regulatory framework for medical devices

Meeting with Angelika Niebler (Member of the European Parliament)

1 Dec 2023 · European Health Data Space

Meeting with Peter Liese (Member of the European Parliament)

29 Nov 2023 · Austausch

Meeting with Helena Braun (Cabinet of Vice-President Maroš Šefčovič)

21 Nov 2023 · Healthcare system in the European Green Deal; specific input on the Packaging and Packaging Waste Regulation proposal

Meeting with Elena Montani (Cabinet of Commissioner Virginijus Sinkevičius)

21 Nov 2023 · Healthcare system in the European Green Deal; specific input on the Packaging and Packaging Waste Regulation proposal

Meeting with Maria da Graça Carvalho (Member of the European Parliament) and FTI Consulting Belgium and

7 Nov 2023 · Cardiovascular Health

Meeting with István Ujhelyi (Member of the European Parliament)

10 Oct 2023 · European Health Union

Meeting with Karen Melchior (Member of the European Parliament)

10 Oct 2023 · Discussion on the AI Act

Response to Evaluation of the European Union Agency for Cybersecurity (ENISA) and the European Cybersecurity Certification Framework

15 Sept 2023

MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices, and digital health, welcomes the opportunity to respond to the European Commissions open public consultation on the evaluation of the Cybersecurity Act. Please find attached MedTech Europe's response. For more information: Benjamin Meany, Manager Digital Health Medical Device Software Regulation: b.meany@medtecheurope.org.
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Meeting with Birgit Sippel (Member of the European Parliament)

12 Sept 2023 · European Health Data Space (Staff-level)

Meeting with Katherine Power (Cabinet of Commissioner Mairead Mcguinness) and Johnson Johnson

13 Jul 2023 · Medical devices legislation and EU sanctions

Meeting with Birgit Sippel (Member of the European Parliament)

7 Jun 2023 · EHDS

Meeting with Daphne Von Buxhoeveden (Cabinet of Commissioner Stella Kyriakides), Giorgos Rossides (Cabinet of Commissioner Stella Kyriakides)

3 May 2023 · Meeting with the newly appointed CEO of MedTech Europe to discuss the medical device legislative framework

Meeting with Krzysztof Hetman (Member of the European Parliament, Shadow rapporteur)

26 Apr 2023 · Exchange of views on Product Liability Directive (meeting delegated to parliamentary assistant)

Meeting with Maria-Manuel Leitão-Marques (Member of the European Parliament, Shadow rapporteur) and Bitkom e.V. and

20 Apr 2023 · Product Liability Directive

Response to Unique Device Identification assignment for highly individualised devices

19 Apr 2023

MedTech Europe, the European trade association for the medical technology industry, recognizes the goals of a global UDI system and therefore opposes the proposed implementation of Master UDI. Main concern: Europe departs from a global IMDRF-approach on UDI which comes with a long list of disadvantages, for Regulators, Economic Operators, and Patients. MedTech Europe would like to remind the co-legislators on the foundation of the UDI system used in various jurisdictions around the world incl. Europe based on the principles established by the International Medical Device Regulators Forum (IMDRF): The UDI system is intended to provide a single, globally harmonized system for positive identification of medical devices. Healthcare professionals and patients will no longer have to access multiple, inconsistent, and incomplete sources in an attempt to identify a medical device and, its key attributes. [] MedTech Europe wishes to contribute to the public consultation with the following arguments: 1 - The European Union departs from the global concept being the only jurisdiction proposing to implement the Master UDI-DI as a regulatory solution. 2 - The UDI-DI for devices with a high number of variants will no longer identify the type of device uniquely. 3 - The regulatory concept of Master UDI-DI will compromise logistical and supply chain processes, globally. 4 - The practical use of an unconventional EU-specific oversized barcode remains unclear. 5 - Open lists of requirements would cause legal uncertainty and unharmonized implementation across the Union. 6 - The concept is intended to be expanded beyond contact lenses, but the consequences are not yet understood. 1 - The registration of devices with a high number of variants, such as contact lenses, in UDI databases is a point of discussion around the world. No regulator, other than the European Union, is considering a regulatory solution like the Master UDI-DI proposal. Industry believes that in Europe the practical consequence of the technical challenge in EUDAMED has not been investigated in sufficient depth to arrive at the conclusion that a Master UDI-DI is the preferable solution. 2 - The current UDI system as described by IMDRF and utilized by many other regulators globally, provides the ultimate granularity for the unambiguous identification of devices by assigning a globally unique device identification number for a device. Homogenizing previously unambiguously identified devices will lead to loss of detail and identification which needs to be introduced elsewhere to comprehend the uniqueness of a device. 3 - The requirement to assign a Master UDI-DI and place an enlarged UDI-carrier on the label is counterproductive since neither the Economic Operators in the supply chain nor the users are currently able to read the barcode and to process its content. 4 - The proposed additional UDI Production Identifiers (UDI-PI) are considered clinical sizes, and do not meet the definition of a production identifier. Including this data in the UDI carrier requires the addition of a larger barcode to labels that are already strapped for space, may lead to more difficulties for the patient to identify from the label the clinical sizes of the device, negatively affects readability, and causes additional waste. 5 - It is concerning that the text of the draft Delegated Act includes the wording at least in two instances. The draft Delegated Act fails to provide rules defining when a sufficient number and style of parameters is to be used to assign the Master UDI-DI or the now required additional UDI-PIs. 6 - To extend the concept of Master UDI-DI to other product categories will further increase the number of clinical sizes excluded from EUDAMED and transferred in UDI-PIs, with the same resulting drawbacks regarding patient safety, manufacturing and supply chain processes, and disconnection from the rest of the world UDI system (and further depart from IMDRF guidelines).
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Meeting with René Repasi (Member of the European Parliament, Shadow rapporteur)

15 Apr 2023 · Exchange of views on the Product Liability Directive/ Produkthaftungsrichtlinie (PLD) - Staff Level

MedTech Europe urges seven-year transition for medical packaging rules

3 Apr 2023
Topic — The Commission is reviewing packaging requirements to reduce waste and improve design.
Message — MedTech Europe requests a seven-year transition period to implement new packaging requirements. They advocate for material-neutral exemptions and alignment with existing medical device regulations.12
Why — This avoids supply disruptions and reduces costs associated with immediate redesign and recertification.34
Impact — Environmental groups lose as the transition to a circular economy is significantly delayed.5
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Meeting with Sabine Weyand (Director-General Trade)

24 Mar 2023 · China, Russia sanctions and IP Waiver.

MedTech Europe urges tougher enforcement of EU late payment rules

17 Mar 2023
Topic — The EU is revising legislation to combat chronic payment delays across the internal market.
Message — MedTech Europe requests better enforcement against state institutions and a mechanism allowing smaller firms to transfer overdue debt to a debt bank. They also propose clear invoicing criteria and allowing companies to defer VAT payments on unpaid invoices.123
Why — This would reduce the financial burden on companies currently forced to subsidize struggling healthcare systems through long delays.4
Impact — Member states and public healthcare providers would lose the flexibility to use payment delays to manage budget shortfalls.56
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Meeting with István Ujhelyi (Member of the European Parliament) and Koninklijke Philips and Stryker

15 Mar 2023 · European Health Union

Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur)

15 Mar 2023 · European Health Data Space - EHDS

Meeting with Cristian-Silviu Buşoi (Member of the European Parliament, Committee chair)

14 Mar 2023 · medical technology industry, medical devices, digital health

Meeting with Deirdre Clune (Member of the European Parliament) and Stryker

14 Mar 2023 · Medical Device Regulation Amending Text

Meeting with Axel Voss (Member of the European Parliament, Shadow rapporteur) and BUSINESSEUROPE and

8 Mar 2023 · Corporate Sustainability Due Diligence

Meeting with Carlos Zorrinho (Member of the European Parliament, Shadow rapporteur for opinion)

28 Feb 2023 · EHDS

Meeting with Pierre Delsaux (Director-General Health Emergency Preparedness and Response Authority)

16 Feb 2023 · Introduction to the new CEO.

Meeting with Adriana Maldonado López (Member of the European Parliament)

8 Feb 2023 · Reglamento del Espacio Europeo de Datos Sanitario

Meeting with Deirdre Clune (Member of the European Parliament)

7 Feb 2023 · Packaging of medical technologies

Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur)

26 Jan 2023 · European Health Data Space - EHDS

Response to Extension of the transition period for medical devices

18 Jan 2023

MedTech Europe takes note of the European Commissions proposal to amend the transitional measures in the Medical Devices Regulation (EU) 2017/745 and welcomes its recognition of the ongoing urgent risks of medical device shortages in Europe stemming from the Regulation implementation challenges. It is now of utmost importance that the European Parliament and Council of the European Union adopt this legislative proposal as swiftly as possible to restore an acceptable regulatory pathway that enables all categories of medical devices to remain available to patients and healthcare system.
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MedTech Europe urges clarity on Cyber Resilience Act medical exemptions

17 Jan 2023
Topic — A proposal establishing cybersecurity requirements for products with digital elements across the EU.
Message — The association supports keeping medical devices under sector-specific rules to avoid duplicate regulations. They request clear definitions to ensure medical software is not accidentally caught by health data laws.12
Why — This exemption avoids the expense of complying with two separate sets of cybersecurity laws.3
Impact — Conflicting laws may cause legal confusion that delays critical cybersecurity updates for medical devices.4
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MedTech Europe warns new liability rules stifle medical innovation

11 Dec 2022
Topic — Updating EU product liability rules for digital technologies and circular economy models.
Message — MedTech Europe requests a balanced liability framework that preserves the existing burden of proof. They advocate for reciprocal evidence disclosure and the removal of labels characterizing medical devices as inherently complex.123
Why — Maintaining current rules would protect the competitiveness of medical companies by preventing rising insurance costs.4
Impact — Injured consumers face higher barriers to compensation and must surrender private medical records to manufacturers.56
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Meeting with Véronique Trillet-Lenoir (Member of the European Parliament) and Syndicat national de l'industrie des technologies médicales

6 Dec 2022 · Medical devices

Meeting with Nathalie Colin-Oesterlé (Member of the European Parliament, Rapporteur)

30 Nov 2022 · SoHO regulation

MedTech Europe warns AI liability rules risk stifling innovation

28 Nov 2022
Topic — The proposal establishes new rules for claiming compensation for damages caused by AI.
Message — The group suggests merging the proposal with other laws to prevent legal confusion. They call for stronger protections for trade secrets and criticize broad proof requirements that burden defendants.123
Why — Medical device makers would reduce their legal exposure and safeguard their technical designs from competitors.45
Impact — Injured parties lose easier access to technical evidence needed to prove liability in court.6
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Meeting with Deirdre Clune (Member of the European Parliament, Shadow rapporteur)

23 Nov 2022 · Artificial Intelligence Act

Meeting with Barry Andrews (Member of the European Parliament, Rapporteur for opinion) and Nike, Inc.

23 Nov 2022 · CSDDD

Meeting with Helena Braun (Cabinet of Executive Vice-President Frans Timmermans)

9 Nov 2022 · Implementation of EU Chemicals Strategy and the REACH revision

Meeting with Elena Montani (Cabinet of Commissioner Virginijus Sinkevičius)

9 Nov 2022 · Implementation of EU Chemicals Strategy and the REACH revision

Response to Evaluation of the 2012 Directive on waste from electrical and electronic equipment

2 Nov 2022

MedTech Europe - the European trade association for the medical technology industry, including diagnostics, medical devices, and digital health - welcomes the opportunity to contribute to the call for evidence and evaluation of the Waste of Electrical and Electronic Equipment (WEEE) Directive. Building on the experience of the current WEEE Directive, MedTech Europe supports targeted improvements to the Directive to ensure a better harmonisation of requirements across EU Member States, which are presented in the attached document.
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MedTech Europe urges alignment with UN standards on chemical labelling

18 Oct 2022
Topic — EU regulation updating hazard classification and labelling rules for chemical substances and mixtures.
Message — The organization requests EU rules align with UN Globally Harmonized System to avoid regional labelling differences. They propose longer transitional periods: 36 months for substances, 48 months for new mixtures, and 60 months for existing mixtures. They argue changes should be part of core CLP review, not delegated acts.1234
Why — This would reduce supply chain complexity and avoid maintaining separate regional product inventories.56
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Meeting with Karen Melchior (Member of the European Parliament, Shadow rapporteur)

17 Oct 2022 · Data Act

Meeting with Andrus Ansip (Member of the European Parliament, Shadow rapporteur for opinion)

13 Oct 2022 · Global shortage of semiconductors

Meeting with Miapetra Kumpula-Natri (Member of the European Parliament, Shadow rapporteur) and AT&T, Inc.

13 Oct 2022 · Meeting on Data Act

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur for opinion)

28 Sept 2022 · Chips Act, EHDS, Lieferketten

Meeting with Cristian-Silviu Buşoi (Member of the European Parliament, Committee chair)

7 Sept 2022 · CSDD Directive

Meeting with Maria-Manuel Leitão-Marques (Member of the European Parliament, Rapporteur for opinion)

5 Sept 2022 · Chips Act

Meeting with Maria-Manuel Leitão-Marques (Member of the European Parliament)

1 Sept 2022 · AI Act

Meeting with Svenja Hahn (Member of the European Parliament, Shadow rapporteur) and Siemens Healthineers AG

31 Aug 2022 · Artificial Intelligence Act (AIA)

Meeting with Zaneta Vegnere (Cabinet of Executive Vice-President Valdis Dombrovskis)

31 Aug 2022 · shortage of semi conductors

MedTech Europe urges alignment of health data rules

28 Jul 2022
Topic — The European Commission proposal aims to create a shared European Health Data Space.
Message — The group seeks clear legal alignment between new data requirements and existing medical device laws. They demand stronger safeguards for trade secrets and intellectual property when sharing sensitive data. They advocate for using international technical standards to avoid creating unique European barriers.123
Why — This alignment would prevent redundant regulatory burdens and safeguard the industry's competitive technological innovations.4
Impact — Stronger trade secret protections may restrict data access for independent researchers and smaller competitors.5
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Meeting with Maurits-Jan Prinz (Cabinet of Commissioner Thierry Breton)

8 Jul 2022 · product liability directive

MedTech Europe urges F-gas exemptions to protect patient care

29 Jun 2022
Topic — A review of EU rules to reduce fluorinated greenhouse gas emissions.
Message — Exempt medical devices and laboratory equipment from the new fluorinated gas regulations. The industry needs longer transition periods to redesign products safely.12
Why — This prevents costly product redesigns and protects the industry's global market share.34
Impact — Patients and hospitals face potential treatment shortages and reduced diagnostic accuracy.5
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Meeting with Ibán García Del Blanco (Member of the European Parliament, Shadow rapporteur for opinion) and Banco Santander, S.A. and

28 Jun 2022 · Joint exchange of views on the Data Act

Response to Sustainable Products Initiative

21 Jun 2022

MedTech Europe is the European trade association for the medical technology industry, including diagnostics, medical devices, and digital health. MedTech Europe supports the ambition towards more sustainable products in the European Union and circular business models. This is not an easy task, as such an effort must consider the need to maintain the very high health and safety standards of medical technologies and their need for continued availability on the EU market. MedTech Europe welcomes the acknowledgement by the European Commission of the specificities of the sector. As stated in Recital 16 of the proposal for a Regulation on Ecodesign for Sustainable Products (ESPR), it is pivotal to consider the fundamental purpose of medical technologies (i.e., saving and improving human lives) when addressing societal demands for more sustainable medical technologies. The attached document highlights the specific considerations of our sector on the proposal.
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MedTech Europe Urges Global Alignment on Forced Labour Ban

20 Jun 2022
Topic — EU initiative to prohibit products made with forced labour from the single market.
Message — They advocate for a risk-based approach and global alignment to ensure rules remain achievable. The association also stresses providing adequate support for small businesses within complex medical supply chains.123
Why — Global coordination would reduce compliance costs for manufacturers managing highly complex, multi-tiered supply chains.4
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Meeting with Karen Melchior (Member of the European Parliament, Shadow rapporteur) and LinkedIn Ireland

30 May 2022 · AI Act

MedTech Europe warns against auditing hospitals under due diligence rules

23 May 2022
Topic — This consultation addresses a proposed directive on corporate sustainability and human rights due diligence.
Message — MedTech Europe requests limiting due diligence to direct suppliers to protect healthcare provision. They also urge for clearer evidence thresholds and harmonized international standards.12
Why — Limiting liability and scope reduces administrative burdens and legal risks for medical manufacturers.34
Impact — Environmental and human rights groups lose oversight of risks deeper in the value chain.5
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MedTech Europe urges Data Act alignment with health regulations

13 May 2022
Topic — The Data Act creates a framework for sharing and accessing industrial and consumer data.
Message — Narrow definitions of 'data' and 'user' to prevent unintended consequences for medical devices. Align the Data Act with existing healthcare legislation and data protection rules. Tighten rules for data disclosure to public bodies during emergencies.123
Why — Manufacturers would avoid duplicative regulations and protect critical intellectual property from reverse-engineering.45
Impact — Patients may face safety risks if data is misinterpreted outside of clinical oversight.6
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Response to A New European Innovation Agenda

10 May 2022

MedTech Europe − the European trade association for the medical technology industry including diagnostics, medical devices and digital health – is pleased to contribute to the European Commission’s plans for a New European Innovation Agenda. The European medical technology landscape has historically been highly conducive to innovation, characterised by a dynamic demography of start-ups and SMEs. In 2019 alone, nearly 14,000 patent applications were filed, and 10,475 patents were granted by the European Patent Office (EPO) in the field of medical technology. Despite this, in recent years the overall attractiveness of Europe as a region in which our industry chooses to innovate has started declining. We are interested to remain engaged with the Commission in its upcoming work to design this New European Innovation Agenda, and to put it into motion with tangible incentives and measures that would reinvigorate Europe’s attractiveness for innovation. Regarding the specific topics on which the Commission is enquiring: 1) Access to Finance The medical technology sector is notable for the very high proportion of start-ups and SMEs that create, test and develop early-stage innovations designed to improve patient care, the practice of medicine, the efficiency of care delivery, or the functioning of healthcare systems overall. These early-stage innovations often reach a stage where collaboration and partnership with larger companies often become necessary, as their more substantial resources may be needed to complete the necessary clinical validation, regulatory approval and market access stages. The medical technology sector would welcome initiatives which can help improve access to finance for start-ups and SMEs, facilitating private funding and continuing the large-scale deployment of public funding such as, for instance, that of the European Innovation Council. An innovation ecosystem with stronger innovative start-ups and SMEs would make Europe more attractive for the medical technology sector as a ‘jurisdiction of choice’ in which to innovate. 2) Framework Conditions including Legislation Digitisation is a critical evolution embraced by the medical technologies industry for advancing healthcare delivery, improving the functioning and efficiency of healthcare systems, and supporting healthcare professionals. Some developments in digital health are related to Artificial Intelligence but not only. The rapid development of innovative and sometimes disruptive concepts in digital health is often much faster than those foreseen in the regulatory processes of the existing sectoral medical technology legislation, i.e., the Medical Devices Regulation 2017/745 and the in vitro Diagnostic Medical Devices Regulation 2017/746. Pro-innovation regulatory practices, such as regulatory sandboxes, living labs and test beds associating stakeholders in the healthcare value chain should be further piloted and made more widely available to keep the pace of digital innovation in Europe. More generally, when internal market legislation is first created and/or revised, greater attention should be given in the Commission’s impact assessment stage to whether the proposed rules really will enable or hinder innovation. 3) Fragmentation of the EU Innovation Ecosystem Innovation ecosystems in medical technologies are often built around high caliber (university) hospitals with access to large cohorts of patients, excellent scientists, technology providers, innovative start-ups and public or private investors. A critical mass of patients and medical expertise in particular disease areas is key for success at European scale. MedTech Europe supports initiatives to strengthen and interconnect local research and innovation ecosystems. Digitisation might be an enabler to interconnect complementary health and research centres across the Union. Futher, access to specific and cost-intensive capital equipment or infrastructure might critically relevant in some cases.
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Meeting with Pilar Del Castillo Vera (Member of the European Parliament, Rapporteur) and Telefonica, S.A.

20 Apr 2022 · Data Act

Response to Recommendation for strengthened actions against antimicrobial resistance

24 Mar 2022

Effective use of medical technologies can be part of the solution in fighting AMR caused by the over-and misuse of antibiotics and the spread of resistant strains. The effective use of diagnostic tests and medical devices can help to address these challenges by: • preventing and containing the spread of resistant bacteria in healthcare to avoid Healthcare-Associated Infections (HAI); • detecting and identifying bacterial infections and their susceptibility to antibiotics to ensure an appropriate antimicrobial therapy; • monitoring and tracking resistance in healthcare settings. Research and Innovation in the medical technology sector is constantly improving in order to tackle the spread of infections. For instance, infection risks due to contaminated devices (e.g. endoscopes) are becoming a big concern across countries. Single-use products have been developed in different specialities as an effective solution to prevent this risk and further funding would allow for their broader adaptation. Likewise, diagnostic and screening strategies should further focus on improving patient management and controlling HAI. These IVDs often come with rapid detection time to ensure appropriate therapy and patient isolation measures. Generally speaking, the fight against AMR requires a coordinated approach amongst key stakeholders in the human, animal and environmental fields. To this end, it is crucial to understand what is needed to modify behaviours, to achieve better infection prevention, stewardship and prescribing practices (e.g. HAI Prevention protocols/checklists, diagnosis guided prescription, diagnosis driven appropriate treatment duration) across all healthcare settings (e.g. primary care, long-term care facilities and hospitals). It is also necessary to learn more about the system barriers in deploying existing tools and technologies. This might be done by filling in the gaps in governance, funding availability & coordination to implement effective Infection Prevention & Control & antimicrobial stewardship programs, and optimising prescription practice (e.g. prescription is supported by rapid diagnostic tools) in different care settings. In practice, the following policy requests can be made: 1) Infection Prevention & Control (IPC) IPC should be the priority topic of discussion at the EU level. Even if there are no binding guidelines, a harmonised approach at the EU level is welcome. • Dedicate funding within ongoing EU R&D projects for health, and economic outcomes research using IPC Medtech solutions; • create antibiotic control frameworks across healthcare systems to include antimicrobial resistance testing and ensure that the uptake of AMR testing is integrated in various settings. 2) Antibiotic stewardship (AMS): • support the implementation of the EU & national action plans; • ensure and fund adequate resources (trained personnel and investments) in hospitals; • ensure public awareness & HCPs education; • dedicate funding within ongoing EU R&D projects for health and economic outcomes research using AMS Medtech solutions. 3) Real-time surveillance of future pandemics, including AMR: • address EU4health goal ensuring prevention, preparedness, surveillance and response to cross-border health threats; • invest in the necessary tools with leveraging the medical technology industry expertise (e.g. using data interoperability standards); • associate Medtech Europe with the "Union health emergency team" objective of EU4health to provide expert advice and technical assistance in case of a health crisis. About MedTech Europe MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health. Our members are national, European and multinational companies as well as a network of national medical technology associations who research, develop, manufacture, distribute and supply health-related technologies, services and solutions. www.medtecheurope.org.
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MedTech Europe calls for simplified hazardous substance rules

11 Mar 2022
Topic — The European Commission is reviewing the restriction of hazardous substances in electronics.
Message — The association recommends that RoHS be maintained but simplified to resolve sectoral challenges. They request longer transition timelines and more predictable exemption processes to preserve innovation resources.123
Why — This would allow manufacturers to redirect critical engineering resources toward new product development.4
Impact — Patients and hospitals lose access to new technologies and affordable equipment.5
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Response to Waste Framework review to reduce waste and the environmental impact of waste management

21 Feb 2022

MedTech Europe - the European trade association for the medical technology industry, including diagnostics, medical devices, and digital health - welcomes the opportunity to contribute to the call for evidence for an impact assessment regarding the initiative on the revision of the EU Waste Framework. In addition to the medical technology sector’s core goal of saving lives and improving health, environmental considerations are an integral part of our industry’s operations. We acknowledge that preserving a healthy environment is essential in keeping citizens in good health. MedTech Europe, in general, supports the objectives of the legislative proposal for the revision of the EU Waste Framework to improve the overall environmental outcome of waste management and the implementation of the polluter pays principle. The legislative framework that guarantees the safety and performance of medical technologies has recently been overhauled by the adoption of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR). Any new regulatory measures in the context of the revision of the current Directive on Waste with regards to medical technologies should not put in question or endanger existing legislation and the value they provide. Furthermore, it is crucial to ensure that the safety, integrity and availability of these technologies needed for the health of European citizens are duly assessed and are not compromised. MedTech Europe aims to provide a more comprehensive response in the upcoming stages of the public consultation on the revision of the EU Waste Framework and remains committed to keeping the dialogue open with the EU institutions.
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Response to Common Specifications on products without an intended medical purpose listed in Annex XVI (Medical Devices Regulation)

11 Feb 2022

MedTech Europe Would like to suggest some improvements to the text. Please see attached document. Best regards
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Response to EURL tasks and criteria

17 Dec 2021

Thank you for the opportunity to comment. Please see MedTech Europe's feedback in the attachement.
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Response to Liability rules for Artificial Intelligence – The Artificial Intelligence Liability Directive (AILD)

28 Jul 2021

MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health welcomes the opportunity to provide comments on behalf of the medical technology industry to the European Commission on the Inception Impact Assessment regarding the revision of the Product Liability Framework. As previously shared with the European Commission, MedTech Europe supports the baseline scenario. However, should this not be an option, MedTech Europe would support also developing policy option 2.1.a. MedTech Europe supports, in certain specific cases, the alleviation of the burden of proof and recognises that this is something that is already happening in some Member States. Such an alleviation of the burden of proof by allowing courts to infer that a product is defective or caused the damage under certain circumstances, e.g. when other products in the same production series have already been proven to be defective or when a product clearly malfunctions, is a concept that was already applied by courts to different products and different situations in order to properly balance public interest and expectations of safety. On the other hand, MedTech Europe does not support the remaining policy options, as (i) they don’t allow to take full advantage of the impact and benefits of AI in the healthcare sector for patients, healthcare professionals and healthcare systems, or ,(ii) regarding the option to broaden the scope, MedTech Europe believes that in many cases it is not necessary as there are already existing regulations applying to medical technologies (or medtech) products by which those cases/aspects are covered/addressed and enable victims to take recourse.
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Response to Commission Implementing Regulation on EUDAMED

22 Jun 2021

MedTech Europe - the European trade association for the medical technology industry including diagnostics, medical devices and digital health - is pleased to submit input to this public consultation. Our consolidated technical comments are enclosed as a single document. Below we highlight some key points: 1. The completion of the data submission depends on notified bodies in case of devices with product certificates (status change from ‘submitted’ to ‘registered') therefore its execution cannot be controlled by manufacturers. The date of submission (when acknowledgement received) should be relevant for determining when the manufacturers complied with their legal obligations instead of the date of registration. 2. Technical documentation for envisaged changes should be made available with sufficient time (i.e. 6 months) before taking effect. This provides sufficient time for Eudamed authorised users to adapt, test and validate/verify systems, processes, policies and procedures prior to submitting any information or records to EUDAMED. All changes shall be made available in a “playground” well in advance of launching in production, so the impacted stakeholders have adequate time to test. The Commission shall provide a change history document (Release Notes) to make user aware of the changes. 3. Industry highly disagrees with the described “malfunction mode” and supports having no fallback manual option in case of system downtime. The system is the only way to perform any necessary submissions in a meaningful way also supporting data integrity. The creation of a complex shadow system leads to the duplication of data, efforts, legal requirements, and unsynchronised data between the Competent Authority and Eudamed. Therefore, we request Commission to develop and implement an overall disaster recovery plan and the availability of backup processes and systems. The responsibility of system failures and malfunctions should be with the EU system owner and not the users of the system. Eudamed should provide “high availability services” to keep downtime to an absolute minimum. When the Commission has established that the malfunction has ceased, it should communicate that information not only to the national competent authorities concerned and to the notified body but to all authorised users. 4. Notifications for all planned downtimes should be provided at least one week in advance unless there is a security or data integrity risk. The notifications by the European Commission about announced downtime or malfunctions need to be proactive in nature (notification to all authorised users e.g Local Actor Administrator (LAA) and providers with established access points to EUDAMED) and should go beyond just announcing on the restricted website or on the public website which would require constant monitoring of the sites. 5. The suspension of submission periods should be automatically effective when malfunction declared by the European Commission occurs. 6. When the Commission has displayed the notice, and actors are informed, they shall without undue delay enter the data that they were hindered to submit during the malfunction in Eudamed. 7. We suggest that the Commission not only detects fraudulent activity but also investigates the data impacted associated with the fraudulent activity. 8. Eudamed shall be accessible through machine-to-machine data exchange services for all actors including Economic Operators. Please add them under Article 2. 9. The time frame for approval of actor registration requests is not defined. To create predictability, please define timeframe e.g. 15 days. 10. Please define “timely assistance” for providing support. E.g. Eudamed support acknowledgement to be performed within a specified time period (targeting 48 / 72 hours) and not be automated.
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MedTech Europe Seeks Essential Use Exemptions from Chemical Restrictions

1 Jun 2021
Topic — EU revision of REACH regulation governing registration and restriction of chemicals.
Message — The association requests reform of the Authorisation and Restriction processes to introduce an Essential Use Concept for medical technologies. They want a formalized transparent process that accounts for long product redesign times and allows exemptions for essential medical applications.123
Why — This would reduce administrative burden and allow them to focus resources on innovation instead of compliance.456
Impact — Environmental and health advocates lose stronger restrictions on hazardous chemicals in medical devices.78
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MedTech Europe urges socio-economic impact assessment for chemical classifications

1 Jun 2021
Topic — Revision of EU regulation on classification, labelling and packaging of chemicals.
Message — The organization requests comprehensive assessment of how chemical classifications affect availability of medical technologies. They want safeguards to prevent unjustified bans of safe uses and realistic implementation timelines. They also seek international alignment with UN standards rather than unilateral EU deviations.123
Why — This would protect their products from regulatory restrictions and give them more time to adapt.45
Impact — Public health advocates lose stronger protections against hazardous chemicals in medical devices.6
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Response to Electronic instructions for use for medical devices

25 May 2021

MedTech Europe is pleased to provide its comments via the enclosed document.
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Response to Evaluation and revision of the general pharmaceutical legislation

26 Apr 2021

As the association representing the medical technology sector, MedTech Europe welcomes the recognition in the inception impact assessment that pharma health solutions bring about technological advances, and the inclusion of the potential of the digital transformation of health and care. MedTech Europe believes in an integrated approach to policy-making that addresses challenges and breaks down silos by working together across disciplines and regulatory competencies throughout the lifecycle of medicines and medical technologies. MedTech Europe is convinced that specific attention will be required for advanced technologies such as companion diagnostics, combination products, artificial intelligence as well as other information generating technologies, as genome sequencing, will be part of future health solutions providing personalized and high quality care. Considering the expected impact of this legislation on the medical technology industry, MedTech Europe calls to be: • Consulted during the evaluation assessing the appropriateness of the current pharma regulation, including its coherence and complementarity to medical device legislation; the mechanism for continuous and timely adaptation of technical requirements in light of emerging science and technologies; and the ability of EMA on covering advanced technologies in terms of expert network and knowledge base. • Recognized and included as a targeted stakeholder. MedTech Europe believes that a sub analysis on the specific impact for the medical technology sector is required and ought to be conducted. • Part of and have specific assessments. These may include the assessment of other policies in creating a legislative framework for market authorization and accessibility of innovative health solution, that include pharma, medtech and digital parts. MedTech Europe is committed to facilitate a broad input from the medtech and digital health industries through our direct corporate members and our national associations (covering more broadly SMEs). As such, MedTech Europe seeks a policy option that will ensure that the needs of complex and future health and medical systems are met. Such an option will create regulatory attractiveness, system incentives, and adaptability and simplification of legislation. Further aspects of importance are measures to avoid shortages and the role of EMA. In essence, MedTech Europe suggests a policy that addresses the issues of: (1) innovating the management of care (incl.(cost)-efficiency gains in care delivery and product supply, integration of care, patient safety of care delivery); (2) transformative health system resilience; (3) Implementation of value based health care. Addressing these issues will have high economic and social impact across health and medical systems. MedTech Europe finally calls for specific financial incentives allocated to advanced innovative technologies as part of health solutions. This will be a way forward to improve accessibility, affordability of health solutions and contributing to the overall health and wellbeing of European citizens.
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Response to Revision of the NIS Directive

18 Mar 2021

We welcome the NIS 2 Directive proposal as an improvement over the current NIS Directive. Relevant sectoral guidance could promote further harmonisation and clarity on how to act when cyberincidents are putting healthcare and patient safety at risk. RECOMMENDATIONS * An adequate level of cybersecurity in healthcare is essential for ensuring the provision of medical care, patient safety and the protection of health data. Security of healthcare systems will also advance the trust in the use of innovative healthcare solutions. The medtech industry is committed to delivering products and services that meet requirements that contribute to these goals. * We acknowledge the references to Medical Device (MD) and in vitro Diagnostic (IVD) manufacturers in Annex I, point 5 (Essential Entities) and Annex II, point 5 (Important Entities) and the supervisory measures for Essential Entities and Important Entities, e.g., ex-ante and ex-post regime versus ex-post regime. Nevertheless, we want to highlight that the medical technology industry is already under rigorous supervisory, auditing and post-market surveillance regimes that include cybersecurity requirements under the new Medical Devices Regulations (MDR and IVDR) and accompanying guidance (including software as medical device and IT systems). We welcome strengthened coordination between the national Single Points Of Contact on cybersecurity (SPOC) and the national competent authorities responsible for medical devices and in vitro diagnostics. However, in the interest of legal consistency and respect for the Lex Specialis principle, we would strongly urge against any creation of duplicative or parallel certification requirements on top of the existing cybersecurity provisions of the MDR and IVDR. * We emphasise the importance of consulting with the industry in drafting the list for “medical devices as critical during a public health emergency”, which would classify the manufacturers as Essential Entities. * We also note that the classification of medical devices’ manufacturers as “critical during a public health emergency” and “non-critical” in other circumstances could lead to two supervisory regimes under the current proposal for a given manufacturing facility. * We stress the importance of uniform implementation of the NIS 2 Directive across the EU Member States to avoid fragmented regulatory requirements and procurement requirements as laid down in Article 5.2.(b) when operating in more than one EU Member State. Additionally, after the entry into force of this Directive, it will be necessary to clarify which ENISA channels will be employed to receive the information required to maintain the registry for Essential and Important Entities (as per Article 25). * Cybersecurity is a shared responsibility of medical device manufacturers, healthcare providers, vendors, and patients. Accordingly, the scope of this Directive should consider the risks involved, and apply the same provisions, on all players in the supply chain, to ensure a fair and balanced approach. We therefore encourage efforts to improve cybersecurity awareness through programmes initiated by the Member States’ competent authorities under the proposed Directive. * We support the risk management approach for both Essential Entities and Important Entities under the proposal but emphasise the leverage of current (sectoral) risk management standards and best practices that have international consensus. * We disagree with setting fines based on “worldwide” annual turnover, which exceeds the scope and jurisdiction of the Directive, and which is considered punitive rather than effective, proportionate, and dissuasive. * We welcome the requirements laid down in article 26 to improve cybersecurity information sharing, as long as this is realised among trusted partners and with proper sharing agreements. We look forward to working with the EC, ENISA and stakeholders to advance cybersecurity in healthcare. Full response attached.
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Response to Modernising the EU’s batteries legislation

1 Mar 2021

MedTech Europe supports the European Commission’s ambition to ensure a competitive, circular, sustainable and safe value chain for all batteries placed on the EU market. MedTech Europe considers the proposed Regulation a reasonable renewal of the existing Battery Directive. MedTech Europe recommends some adjustments to this proposed Regulation (as mentioned below), to assure a feasible implementation of this legislation for the medical technology industry. Validation and possible design changes in medical technology require a suitable transition period MedTech Europe’s submission focuses on the potential changes to the existing Battery Directive that may have a negative impact on the batteries that the medical technology industry uses. The proposed Regulation requires that from 1 January 2027, portable batteries of general use shall meet predefined values for electrochemical performance and durability. The performance of batteries (non-rechargeable, portable batteries of general use) the medical technology industry uses for its products (medical devices and in vitro diagnostic medical devices (IVDs)) has been tested and validated to ensure patient safety and performance considerations. Once battery suppliers meet the electrochemical performance and durability criteria set for 1 January 2027, the batteries will have to be tested in combination with medical technology. The aim will be to ensure that the criteria for patient safety and performance of medical technology are still met. If this is not the case, a design change may be required to ensure continued product performance and patient safety. This will require a transition period of at least 2 years for two reasons: 1) To validate the performance of the new battery combined with the medical technology, and 2) If the changed batteries specifications will require product design changes. During this transition period, the medical technologies manufacturers should be granted the possibility to place their products on the market combined with batteries that meet the requirements of the current Battery Directive. Changes in products in the medical technology sector require a longer transition period than, for example, consumer products, because of the need for validation and regulatory approval. As recognised in multiple pieces of existing legislation (e.g., the RoHS Directive, and the POPs and REACH Regulations), the medical technology industry requires additional implementation time before in order to ensure that the transition to upgraded environmental rules happens smoothly, without interruption to the supply of medical care to European citizens. 
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Response to European Health Emergency Response Authority

24 Feb 2021

MedTech Europe agrees with and welcomes the Commission’s analysis of the vulnerabilities in European health preparedness and crisis response for cross-border health threats highlighted by the COVID-19 crisis, as well as the structural weaknesses which are the underlying contributing factors to these vulnerabilities. Taking into account the experience of the medical technology sector during the COVID-19 crisis, we propose the following reflections on the inception impact assessment for the European Health Emergency Preparedness and Response Authority (HERA). In order to effectively reach the objectives of the European Health Emergency Preparedness and Response Authority, it is essential that an independent structure in the form of an agency be setup in order to ensure dedicated resources are maintained over time, as there is a genuine risk that material support for preparedness in the face of public health emergencies will decline over time otherwise. Equally important is the need to maintain focus on the mission of emergency preparedness. The Commission noted as one of the weaknesses of the EU response regulatory hurdles faced by new technologies. This should be actively addressed to overcome regulatory hurdles in accessing the European market for innovative technologies. Many of which will be developed to overcome future public health threats. This would include a role in ensuring that derogations or emergency authorizations can be coordinated at the EU level for medical technologies needed to deploy effective countermeasures. Ensuring continuity of care for the population who needs medical attention not directly related to the public health crisis should be a core element in any preparedness strategy. Just as it is important to minimize the impact of the root cause of any public health emergency, it is also essential to minimise the excess mortality which relates directly to the state of crisis that healthcare systems may be operating under in times of a public health emergency. We have also experienced severe disruptions to global logistics during the COVID-19 crisis. Thus, mechanisms for the mobilisation of logistic capacity to ensure the prompt delivery and distribution of medical countermeasures across the EU should also be part of the remit of HERA. As such we believe that the best option going forward is that of a standalone executive agency as an operational authority similar to what is proposed in option 2.1 of the impact assessment which would include the mandates and the three additional responsibilities outlined above. For the medical technology industry in particular the following areas of activity and responsibility remain critical: • Establishment of mechanisms to assess cross-border health threats and identifying and deploying suitable medical countermeasures. • Supply and demand analysis coupled with market intelligence to enable the allocation of manufacturing capacity as needed during an emergency. • A review of the current procurement practices both in preparation of and during a public health emergency in particular a review of the joint procurement practices to ensure a more effective process that closely matches the real demands for medical countermeasures is key. • An integrated mechanism for stockpiling and distribution of medical countermeasures. • Support in the development of new technologies needed to address new public health emergencies. • Implementing effective mechanisms for the rapid regulatory approval of innovative technologies developed to overcome future public health emergencies. • Ensure public health systems continue operating for all patients, thus minimizing excess mortality. • Enable the mobilisation of logistics capacity in times of crisis to mitigate the disruption of the distribution of medical countermeasures. We remain committed to supporting projects like this one for the mitigation of future public health threats.
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Response to Legislative framework for the governance of common European data spaces

8 Feb 2021

MedTech Europe welcomes the opportunity to respond on the proposal for a European Data Governance Act (DGA). We support the European data strategy and specifically the sectoral project of the European Health Data Space. THE MEDTECH INDUSTRY delivers products, services or solutions that improve prevention, diagnosis, treatment, monitoring and management of health and lifestyle. Digital health and care technologies can innovate and improve access to care and quality of care, and make healthcare delivery more efficient. The medtech industry invests significant resources in research. The sharing of (personal) data, with the appropriate safeguards, helps monitoring the safety and effectiveness of existing products on the market, and supports services for medical technologies. Hence, harnessing the power of health data will advance and accelerate research and innovation in medical technologies and services for the benefit of European citizens. We support the objectives of the proposed DGA to facilitate data sharing across sectors and Member States and to set a framework for sectoral data spaces. GENERAL COMMENTS We welcome the architecture of the proposed DGA and support: * The creation of data intermediaries and the single contact points in Member States. * The creation of a ‘European Data Innovation Board’ in which relevant stakeholders including the medtech industry are represented. * Investment to foster data processing infrastructures. Regarding the proposed creation of multiple (regulatory) bodies and authorities, we would suggest combining these bodies, to limit the administrative burden and avoid fragmentation. THE IMPACT ON CONTRACTS We recommend clarification that the DGA not impact on the B2G data sharing market, as it is unclear whether licensed data would be made available to re-users. This could impact the established economic model of medtech companies, and the collaboration of industry with the public sector. We recommend clarifications on the scope of the Regulation, when it comes to categories of public sector data available for re-use. THE INTERPLAY BETWEEN THE DGA & THE GDPR We recommend: * Define the concept of ‘data’ as understood by the DGA and clarify it is limited to digital data. We support a broad definition of “data”. * Define what is meant by “non-personal data”. We recommend not to restrict any cross-border data transfers to non-personal data. * Provide clarity on how mixed datasets should be handled and when they can be considered anonymous. * Align the DGA with the wording of the GDPR, when it comes to the legal basis for processing of special categories of personal data. * Align definitions such as ‘pre-processed data’, ‘main establishment’ and ‘access’ with the GDPR. PROVIDERS OF DATA SHARING SERVICES We recommend: * The role of providers of data sharing services to be further clarified. * Caution regarding the verification of the results to not compromise any trade secret or IP rights of the re-user, avoiding a potential public disclosure. * Cooperation between competent authorities of Member States, regarding cross-border data sharing services, in the form of a one-stop shop mechanism like the one under the GDPR. * To not exempt data altruism organisations from the requirements for providers of data sharing services. DATA ALTRUISM We recommend paying attention to these risks: * creating an additional legal regulatory layer without eliminating existing complexity. * establishing new, additional obligations that would influence the GDPR and companies’ established processes on data protection compliance. * the planned consent form to not do justice to current and future complexity. * not to encompass the possibility of research and development of commercial products and services in medical technology. * the concept of “general interest” to exclude commercial companies. For more information and detail on the above points, please consider the attachment, or go to www.medtecheurope.org.
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Meeting with Daphne Von Buxhoeveden (Cabinet of Commissioner Stella Kyriakides), Giorgos Rossides (Cabinet of Commissioner Stella Kyriakides)

5 Feb 2021 · Meeting with MedTech Europe on new Medical Devices Regulations, MRA with Switzerland and Health Union package.

Response to A European Health Data Space

3 Feb 2021

MedTech Europe supports the project of the European Health Data Space (EHDS). The medtech industry is at the heart of the health data ecosystem. The industry’s digital health solutions annotate and enrich data to turn raw data into datasets of high value. Innovation in the development of new treatments and protocols is highly dependent on its ability to access and appropriately utilise health data. The EHDS can accelerate the digital transformation of Europe’s healthcare systems and create the conditions for better use of health data by * Building a trustworthy health data ecosystem; * Improving the quality of health data; * advancing the conditions for research and development by accelerating capabilities for the re-use of health data; * creating an institutional infrastructure for easy access to health data; * supporting the development of skills in the healthcare workforce and the optimal integration of AI systems in healthcare. The EHDS can thus reinforce the competitiveness of European industry and new business opportunities. BARRIERS We would add the following elements to the problem description: * Citizens should be empowered to access and manage their own health data. Electronic health record (“EHR”) systems and digital health tools should be improved to fully deliver on the right to portability of health data for citizens. * The industry supports the voluntary European EHR Exchange Format as a critical means to overcome Europe’s digital health fragmentation. * The industry shares the view that the fragmentation in GDPR implementation and inconsistent interpretation across the EU pose critical obstacles for health data use. * The divergence in regulations and administrative practice at the national level often hinder the cross-border provision of health services. * AI in healthcare has considerable potential. We would advise caution when considering introducing new generally applicable AI-specific legislation. Guidance may enable developers to navigate the EU regulatory environment more easily and efficiently. THE LEGAL BASIS OF THE EHDS The MedTech industry believes that the EHDS should not be limited to the promotion of cross border services or data transfers. It should also address the broader issue of data access for permissible data use. Clarification or more consistent application of the GDPR across Europe is urgently needed. We support the idea that, while assessing the need for new legislation, the application of existing legislation should be taken into account, to avoid overlapping and conflicting regulations. We favour an EU-wide alignment as opposed to Member State legislation. RECOMMENDATIONS * The EHDS needs to correspond to national and regional initiatives to create a trusted personal space for citizens to safely store and manage their health data. * The health data governance framework must foster trust among citizens, patients, and healthcare professionals that their data benefits research and innovation, and it is used appropriately. * MedTech Europe calls for more harmonisation of GDPR interpretation and application across the Member States. * Companies accessing data should not be required to disclose the purposes of their project. * The governance framework should prioritise standardisation needs and improve data interoperability. * Cybersecurity needs to be a cornerstone of the EHDS. * Applicable liability regimes regulating medical technologies continue to be fit for purpose. * The EHDS should make it a priority to harness datasets for training and testing AI solutions in healthcare. * Promoting professional education and training towards digital literacy for healthcare professionals should be an integral part of the policy agenda. For more information and detail on the above points, please consider the attachment, or go to www.medtecheurope.org.
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Response to Proposal for a Regulation on a Union framework addressing public health emergencies (EMA)

2 Feb 2021

Regaring the proposed Regulation on the reinforced role of EMA, MedTech Europe suggests to take the following considerations into account (full position attached): 1. Involvement of Civil Society in the Executive Steering Committee on Medical Devices (Art19): a.COVID-19 has demonstrated the need to involve the medical technology industry and other partners of civil society in an ongoing dialogue throughout the full duration of a public health emergency, starting at the earliest moment possible. b.To ensure that this happens systematically and consistently in future crises, the proposed Regulation should explicitly include medical device interest groups – including but not limited to industry stakeholders – in the composition of the Medical Devices Steering Group, not merely as third partied for the Steering Group’s Chair to invite on an ad hoc basis. c.Furthermore, the Regulation should clarify how the newly established Steering Committee relates to and interacts with the existing Medical Device Coordination Group (MDCG) operating under the new Regulations for medical devices and in vitro diagnostics. 2. Monitoring shortages during a public health emergency (Art24): a. Great care must be taken when obliging individual manufacturers to submit device-specific data to the Agency and the Medical Devices Steering Group. Notably: i. The proposed Regulation should require the Agency and Steering Group to always apply, proportionate, justifiable, and transparent criteria when defining the type, depth, and frequency of their data requests to manufacturers. Moreover, any deadlines set by the Agency must be proportionate to the quantity and complexity of the data requested. Failure to include such safeguards could lead to undue bureaucracy, thereby endangering to manufacturers’ ability to maintain focus on optimising supply of critical devices needed to combat the public health emergency. ii. The proposed Regulation requires more specifics about how the Agency would apply in practice its obligation to protect commercially confidential information from “unjustified disclosure”. Medical devices manufacturers can require much higher levels of protection of their commercial information, as concepts from the medicinal products sector (such as market exclusivity and regulatory data exclusivity) do not exist for the medical devices sector. 3. Management of expert panels for medical devices (Art28): a. MedTech Europe questions the Commission’s notion that expert panels designated in accordance with Implementing Decision 2019/1396 are particularly relevant to the real-life management of a public health emergency. The co-legislators defined the role of these panels always with a view to the ‘routine’ assessment and oversight of medical devices and Notified Bodies. The panels are not described anywhere in the Medical Devices Regulation 2017/745 or the in vitro Diagnostic Medical Devices Regulation 2017/746 as having any specific role in crisis management. b. As such, we do not consider it appropriate for this proposed Regulation that aims at addressing crisis preparedness and management, and which is part of a “package of urgent measures” and “not accompanied by an impact assessment,” to transfer the secretariat of these expert panels to the Agency. Instead, such a proposed transfer should be decoupled from this Regulation, and, if truly justified, made again the framework of a full ordinary legislative procedure, i.e., one accompanied by a prior impact assessment and stakeholder dialogue, and with ample opportunity for the co-legislators to give such a proposal the consideration it merits. c. If despite our above concerns, the Commission’s proposed transfer of responsibility to the Agency must under no circumstances jeopardise the timely availability of these panels: the full deployment and of these panels was already needed in 2019, and action must be taken now to get the panels fully up and running, as soon as possible.
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Response to Proposal for a Regulation establishing a European Centre for Disease Prevention and Control (ECDC)

2 Feb 2021

MedTech Europe welcomes the objective and the proposed text on the extended role of the ECDC, as part of the European Health Union and suggestes to take the following considerations into account: 1. Involvement of Civil Society (Articles 5a and 5b): a.COVID-19 has demonstrated the need to involve the civil society in order to combat public health threats – in particular prevention, preparedness and response planning would benefit from the expertise and resources of civil society in order to best face new public health emergency. b.To ensure that this happens the Regulation should include civil society (including healthcare services, scientific societies, and industry) in activities aimed at the prevention of communicable diseases and preparedness and response planning for future public health emergencies. 2. Forecasting (Articles 3 and 5b): a.One of the major concerns during the SARS-CoV-2 pandemic has been ensuring sufficient supplies of medical technologies throughout healthcare systems in the EU. In this context forecasting by the ECDC should insofar as much as possible include forecasts that will help predict demand of key medical technologies during the evolution of the public health emergency. Of particular value would be forecasts of ‘Intensive Care Unit’ (ICU) usage and related device and diagnostic needs. b.In addition, forecasting that would help determine the types and amounts of personal protective equipment to be used both by frontline healthcare professionals and by the population at large would enable a much more effective level of preparedness and response to any public health emergency as production capacity could be ramped up more efficiently to meet the expected demand. 3. Protective measures (Article 8b): a.During the early phases of the SARS-CoV-2 pandemic it was very challenging to establish clear guidelines at the European level for the use of protective equipment not only for frontline healthcare workers but also for the population at large. Thus, the ECDC should be explicitly tasked to consider the development of guidance addressing the effective use of protective measures as well as any extraordinary measures which may be taken in the case of shortages of protective equipment. 4. Reference laboratory networks and support of transfusion transplantation and medically assisted Reproduction (Article 5): a.In the course of establishing the network of reference laboratories, especially when it comes to the provision of reference materials for use in quality schemes due consideration should be given to the role of the Joint Research Centre (JRC) which is a world-class centre of excellence for the preparation of biological reference materials. As such involvement of the JRC in the establishment of these reference networks would be a positive contribution helping in particular to reinforce the tools to ensure the adequate running of quality control schemes for the networks. b.One of the big concerns at the start of any public health emergency which is caused by an emerging infectious pathogen is the ability to rapidly identify and make available to developers of diagnostic tests suitable samples which can be used to develop and validate effective assays to diagnose the emerging pathogen. As such considerations should be given within the networks for the support of transfusions and to the establishment of networks of biobanks to enable the storage and capacity 5. Extending the mandate to incorporate non-communicable diseases: a. The COVID-19 pandemic had an impact not only on acute care but on the healthcare system and delivery overall. In the cause of the pandemic a significant delay in screening, diagnosis and care in other areas was experienced. b. Thus, it is suggested that ECDC data collection and surveillance during crisis also encompasses areas of non-communicable diseases to capture the full impact of the crisis and set the scene for possible action. Full document in attachment.
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Response to Proposal for a Regulation on serious cross-border threats to health

2 Feb 2021

MedTech Europe welcomes the objective of the European Commission’s proposed ‘Health Union’ package of 11 November 2020. Better coordination and pooling of efforts are needed across the Union to strengthen Europe’s preparedness to tackle future public health emergencies, and the proposed Regulation on serious cross-border threats to health constitutes an important step in this direction. Nevertheless, MedTech Europe believes the proposed Regulation can be substantively improved in several key respects, and calls on the co-legislator to take these considerations into account: (1) Involvement of Civil Society (Article 25): a. During the SARS-CoV-2 pandemic there has been a very effective dialogue established between industry and European Commission services to follow and mitigate the impact of shortages of crucial medical technologies in the clearing house mechanism. It is strongly recommended that at the moment where signs of another imminent public health emergency arise such mechanisms be activated rapidly to respond to any potential shortages which could be encountered as part of the emerging threat. b. Additionally, the discussions with civil society can help to establish issues related to the availability of diagnostic capacity across the EU. (2) Joint procurement of medical countermeasures and stockpiling (Article 12) a. The joint procurement mechanism as setup during the SARS-CoV-2 epidemic has shown itself to be useful in preparing for a public health emergency but with some important shortcomings when used as part of the emergency response itself. b. Notably – while the JPAs for protective equipment and for diagnostics have been successful, he JPA for ventilators has not been – Member States issued initial requests for substantial amounts of ventilators which were then never translated into actual purchases (by orders of magnitude). This exacerbated a situation where manufacturers produced and held stock based on the demand from the JPA which was then never fulfilled. c. In particular, explicit efforts should be made to coordinate the JPA with national procurement initiatives to avoid a double demand bubble as was seen in the first months of 2020 during the SARS-CoV-2 pandemic. d. Joint procurement can be a valuable procurement tool for the establishment of stockpiles, even those being managed under the RescEU mechanisms. This too should be considered in the document. (3) EU Reference laboratories (Article 15) a. The responsibilities of reference laboratories as laid out in article 15 include the development of reference materials and elaboration of external quality assessments, as well as collaboration and research into the public health emergencies – in all of these areas the role of the Joint Research Centre should be considered as the JRC is a world-class centre for the development of biological reference materials which are essential for external quality assessments. As such the role of the JRC should be leveraged as part of the reference laboratory network.
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Response to Revision of the Union legislation on blood, tissues and cells

14 Dec 2020

MedTech Europe - the European trade association for the medical technology industry including diagnostics, medical devices and digital health - welcomes the opportunity to contribute to the initial consultation regarding the revision of the Union legislation on blood, tissues and cells. Medical technologies - i.e., medical devices and in vitro diagnostic medical devices, which must comply with Regulation (EU) 2017/745 and Regulation (EU) 2017/746, respectively - are critical to the collection, testing, processing, transport, storage, and administration to patients, of blood, tissues, and cells products as well as to ensure pathogen reduction. The comments submitted in the attachment are focused on flagging that the final legislative proposal requires an especially careful construct of enforcement possibilities versus flexibility to quickly update guidance documents, technical rules, and specifications in line with technological advancement.
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Response to Green Paper on Ageing

13 Dec 2020

MedTech Europe’s Eyecare Sector Group welcomes the European Commission’s initiative to address the challenges of the ageing population in Europe. Considering the demographic trends and increasing demands on national healthcare systems (‘HCSs’), building a long-term, patient-centric plan for our elderly is more important than ever - and an essential aspect of active and healthy ageing. It would contribute to greater intergenerational solidarity and societal inclusion of older people. Eye diseases, especially cataracts, are a significant but often neglected issue among ageing populations. Cataracts are a major cause of visual impairment (‘VI’) and blindness, affecting 64% of the European population aged over 70 years (1). They directly impact the quality of life (‘QoL’) and independent living of people and represent a significant cost to society. Higher levels of VI limit activity and reduce mental well-being of elderly people (2). Limited activity also often prevents elderly from remaining economically productive and leads to an increase in healthcare costs due to sedentary lifestyle. Addressing eye diseases should therefore be a core pillar of promoting healthy and active ageing. There is an opportunity for the European Union to lead on this issue in several ways. 1. Promote early diagnosis and treatment of VI and cataracts Early diagnosis and treatment of eye health issues enable the elderly to remain active and reduces healthcare costs. Earlier diagnosis would support early interventions where needed, reducing the prevalence of longer-term disability from untreated conditions, the need for prolonged treatments, as well as falls and other harms related to poor sight. Together, these interventions can reduce overall healthcare costs. The elderly would also gain increased autonomy and QoL (3) with a wider range of choices for early interventions. Cataracts surgery is proven to be one of the most cost-effective procedures across all medical specialties (4). The benefits of early intervention are highly significant. We call on the European Commission to promote early diagnosis and treatment of visual impairments. 2. Reduce inequalities in eyecare across Europe COVID-19 has disproportionately impacted the elderly. Delays / cancellation of non-emergency procedures like cataract surgery have caused further hardships (5), as delaying treatment often results in an increase in disability and reduced activity (6). Patients on prolonged waiting lists (> 6 months) for cataract surgery may experience vision loss, increased risk of falls, and ultimately, poorer QoL during the waiting period (7). We call on the European Commission to facilitate best practice sharing amongst Member States for managing the backlog of non-emergency procedures caused by the COVID-19 pandemic, with the aim to reduce inequalities in access to health services and longer-term costs to societies. 3. Increase the uptake of digital technologies to support the ageing population Digital devices can streamline healthcare processes and support our elderly at home. For eye health, they can facilitate screening and diagnosis, and reduce intervention times and pressure on national HCSs. We call on the European Commission to facilitate investments in digital technologies that are tailored to the needs of and can bring significant benefits to our ageing population. 4. Ensure healthcare sustainability by adopting a value-based approach The G20 made a commitment to sustainable health via Value-Based Healthcare (VBHC), which improves patient outcomes and saves money over time through a holistic approach to healthcare. This approach should be promoted by the EU to support active and healthy ageing. New treatment options, that support healthy ageing by significantly improving patient autonomy, are often not sufficiently reimbursed, despite the value they bring. We call on the European Commission to facilitate best practice sharing among Member States regarding VBHC.
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Response to Commission Implementing Decision on standard contractual clauses for the transfer of personal data to third countries

10 Dec 2020

MedTech Europe welcomes the opportunity to provide comments and appreciates the efforts made by the European Commission to design those new clauses. Please find our comments attached.
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Meeting with Annukka Ojala (Cabinet of Commissioner Stella Kyriakides), Daphne Von Buxhoeveden (Cabinet of Commissioner Stella Kyriakides)

10 Dec 2020 · VC Meeting - The role of medical technologies in the fight against antimicrobial resistance and healthcare acquired infections

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

6 Nov 2020 · Videoconference with Pharmaceutical Industry Associations to discuss shortages of medicines and medical devices including diagnostic tests in the context of COVID-19 pandemic

Meeting with Stella Kyriakides (Commissioner) and

30 Sept 2020 · Call with pharmaceutical and medical device supply Chain on COVID-19

MedTech Europe urges broader chemical trace exemptions for parts

29 Sept 2020
Topic — A proposal to amend the Persistent Organic Pollutants Regulation regarding chemical limit levels.
Message — The industry supports a trace contaminant limit for medical devices but wants it expanded. They request explicit coverage for manufacturing processes, spare parts, components, and accessories.123
Why — This would prevent production disruptions and ensure EU manufacturers are not disadvantaged by import rules.45
Impact — Environmental groups may oppose this as it permits higher chemical concentrations for longer.6
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Response to Requirements for Artificial Intelligence

10 Sept 2020

Artificial Intelligence (AI) in medical technologies has the potential to deliver on the promise of better healthcare in Europe. To optimise the value of AI in the healthcare sector, policies need to remain flexible and follow the evolution of technological development, allowing space for technology to thrive. Therefore, we at MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health, are keen to bring today our healthcare expertise and perspective to the AI policy conversation via our attached response to the public consultation on an EU legal act for Artificial Intelligence. We greatly welcome the aim of the European Commission (EC) to address a number of legal and ethical issues, raised by AI, to foster the development and uptake of AI, and to avoid legal fragmentation across Member States. We agree that European citizens need to have confidence that their medical technologies, with or without an AI component, provide a high level of safety and quality for patients. In the medtech sector, the safety and effectiveness of medical device software, including "AI with an intended medical purpose", is already addressed through existing, recently reinforced, regulations, i.e. the Medical Device Regulation (EU) 2017/745 (“MDR”) and the In vitro diagnostics Regulation (EU) 2017/746 (“IVDR”). It is for this reason, that MedTech Europe supports the idea that, while assessing the need for new legislation specific to AI, the application of existing regulations on AI should be taken into account to understand whether any gaps exist, to avoid overlap and conflicting regulations that could cause issues when AI is introduced. Read our full response attached.
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Meeting with Astrid Dentler (Cabinet of Vice-President Dubravka Šuica)

9 Sept 2020 · Green Paper on Ageing; cardiovascular diseases; innovative technologies

Response to Environmental claims based on environmental footprint methods

31 Aug 2020

MedTech Europe - the European trade association for the medical technology industry including diagnostics, medical devices and digital health - welcomes the opportunity to contribute to the initial roadmap consultation regarding the legislative proposal for substantiating green claims. Medical technologies comprise of medical devices and in vitro diagnostics (IVDs), many of which are essential to addressing global health concerns, managing diseases and keeping people in good health. MedTech Europe supports the overall objective of the legislative proposal for substantiating green claims. Medical technology manufacturers in our membership report that well-established methods already exist and are routinely used for measuring sustainability to substantiate green claims that a manufacturer makes. There are numerous initiatives already implemented that provide information on the environmental performance of products and organisations, e.g. voluntary labelling according to well-accepted eco-labels, voluntary phase-outs of certain chemicals or materials, development of innovative and energy efficient devices, life cycle assessments (LCAs), and various other initiatives designed to improve the environmental footprint of products and services. Any new legislation at EU level – whether under the Circular Economy Action Plan or any other initiative – should not put in question or endanger these initiatives and the value they provide. Please find MedTech's Europe complete feedback to the consultation on Environmental performance of products & businesses – substantiating claims attached.
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Response to Review of the requirements for packaging and feasibility of measures to prevent packaging waste

5 Aug 2020

MedTech Europe - the European trade association for the medical technology industry including diagnostics, medical devices and digital health - welcomes the opportunity to contribute to the initial roadmap consultation regarding the review of the requirements for packaging and other measures to prevent packaging waste. We would like to register as an interested stakeholder to contribute to the upcoming stage of the public consultation. Medical devices and diagnostics are used to save people’s lives, to support the diagnosis and treatment of diseases and to keep people at good health. The rules for guaranteeing the safety and performance of devices have been recently overhauled by the adoption of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). In general, MedTech Europe supports the broad objective concerning the review of the essential requirements of the Directive 94/62/EC on Packaging and Packaging Waste, namely the well-functioning internal market through fully harmonised rules on packaging while tackling negative impacts on environment and health from packaging and packaging waste. Article 20 of the Directive 94/62/EC on Packaging and Packaging Waste lays provisions “to deal with any difficulties encountered in applying the provisions of this Directive, in particular, to inert packaging materials placed on the market in very small quantities (i.e. approximately 0,1 % by weight) in the Union, primary packaging for medical devices…”. Any new legislative initiative to revise the current Directive on Packaging and Packaging Waste with regard to medical devices and in vitro diagnostics should be assessed in light of its potential effect on the safety and availability of devices and diagnostics needed for the health and safety of people in Europe. Concepts such as legal certainty aiming at avoiding overlap or inconsistent measures, feasibility and proportionality of measures can be used for such an assessment. MedTech Europe aims to provide a more comprehensive response in the upcoming stage of the public consultation on the review of the essential requirements of the Directive on Packaging and Packaging Waste and remains committed to keeping the dialogue open with the EU institutions.
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Response to Legislative framework for the governance of common European data spaces

30 Jul 2020

Please consider the attached 2.5 page feedback from MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health.
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Response to Modernising the EU’s batteries legislation

9 Jul 2020

MedTech Europe supports the European Commission’s commitment to ensure a competitive, circular, sustainable and safe value chain for all batteries placed on the EU market. Our submission focuses on the potential impact of a ban on primary batteries on the medical technology sector (medical devices and in vitro diagnostic medical devices (IVDs)). Medical technology manufacturers are committed to and have already transitioned to rechargeable batteries where this is possible (e.g. patient monitors, activators), but patient safety and performance considerations require manufacturers to choose primary batteries for a number of remaining applications. The first considerations when designing a medical device are patient safety and product performance. This will result in the choice of battery. Primary batteries are used where the use of a rechargeable battery could affect the performance of a device (e.g. its shelf life), where the device becomes infected (e.g. single use devices), or where it poses a risk to the patient in terms of reliability and longevity (e.g. with lifesaving therapies such as pacemakers and defibrillators). In terms of environmental impact, medical devices containing primary batteries are increasingly designed to offer a long lifetime. By switching to rechargeable cells, the longevity may not increase. In addition, in many cases a more complicated circuit would be necessary, with more electronics, which would have an adverse impact on the environment. The environmental impact from medical devices is already minimised because manufacturers actively seek and provide for the return of many devices at the end of their useful lives. Medical devices are usually complex products which have a long time to market and time-consuming regulatory approval schemes. Changing the design of a medical device to replace a primary by a rechargeable battery will therefore (if technically feasible in the first place) require many years and would come at high cost, preventing innovations in healthcare resulting in new, improved products for patients. While most medical devices and IVDs containing primary batteries are used by professionals, there are a number of others with consumer applications where primary batteries are crucial for device accuracy and safety (e.g. IVD self-tests). When considering the use of primary batteries, it is therefore important to distinguish medical devices of all types from more standard consumer products. An important consideration in this regard is that batteries used in devices which become infected waste cannot be recycled as this would pose a health risk to users and waste management operators. In conclusion, a ban on primary batteries in medical devices and IVDs would potentially degrade patient outcomes, increase risk, and increase potential user errors while increasing costs and waste streams.
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Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

29 Jun 2020 · Videoconference with Pharmaceutical Industry Associations to discuss shortages of medicines and medical devices including diagnostic tests in the context of COVID-19 pandemic

Meeting with Stella Kyriakides (Commissioner) and

29 Jun 2020 · Call with pharmaceutical and medical device industry associations on COVID-19

Meeting with Axel Voss (Member of the European Parliament, Rapporteur)

22 Jun 2020 · AI Civil Liability

Meeting with Stella Kyriakides (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

29 May 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

15 May 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

8 May 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

8 May 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

29 Apr 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

29 Apr 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

23 Apr 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

23 Apr 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

17 Apr 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

9 Apr 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

9 Apr 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Anne Bucher (Director-General Health and Food Safety)

6 Apr 2020 · COVID 19 in vitro diagnostic access and availability for Europe

Meeting with Stella Kyriakides (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

3 Apr 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

3 Apr 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

27 Mar 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

27 Mar 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

20 Mar 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

20 Mar 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

13 Mar 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss possible shortages of medicines and medical devices for the Covid-19 outbreak

Response to Europe’s Beating Cancer Plan

3 Mar 2020

The medtech industry welcomes the EU’s Beating Cancer Plan and is committed to working with all stakeholders contributing to medical advances in the area of cancer. Medical technologies play an essential role in driving the 4 pillars of this plan. In-vitro diagnostics (IVDs) provide information on the likelihood of developing cancer at an early stage, the presence and type of cancer, and treatment success. In addition, surgery and medical devices are especially critical for effective treatment and care. Hence, harnessing medical technologies’ potential and innovations for beating cancer can create value for patients, healthcare professionals and healthcare systems. Our considerations: • New care delivery models: As stated by the EC, cancer care should focus on patients’ needs and preferences (e.g. community care or home treatments) and be done in multidisciplinary ways. This requires replacing prevailing patterns of fragmented care delivery by integrated and value-driven care approaches. • Value of diagnostic information: The value of IVDs lies in the actionable information that they provide to patients, healthcare professionals and health systems at every stage of cancer care – from screening to monitoring. IVDs are vital in determining which treatment will work, and minimise its side effects. The value of diagnostic information does not only provide clinical benefits but an overall increase in the quality of life and safety for patients and the avoidance of unnecessary spending. Better leveraging this source of information should involve investment in screening and laboratory infrastructure and pathology capacity, clear evidence requirements, and reimbursement pathways for IVDs. • Co-morbidity and symptom management: Co-morbidities such as cardiovascular conditions are common in cancer patients. Diagnosing and managing co-morbidities can impact patients’ quality of life and survival. IVD information can help clinicians detect these co-morbidities, i.e. by identifying patients with increased risk of vein thrombosis and pulmonary embolism. Cancer care should also address disease-related symptoms such as pain by means of supportive care. • Healthcare-associated infections and AMR: Some cancer treatments can change the immune and blood systems, and it is estimated that one in five cancer patients needs antibiotics during their cancer treatment. Thus, comprehensive infection prevention programmes and control of opportunistically resistant infections are essential. • Digital health: Leveraging digitisation is crucial for improving cancer treatment pathways and efficiency in health systems. For example, digital imaging and pathology programmes and algorithms can foster comprehensive diagnosing. These and other technologies require investment in increased digital literacy among healthcare professionals, care givers and patients. • Data sharing: Knowledge and data sharing is essential in enabling a broad generation of scientific evidence and hence should not be limited to genomic markers alone. An integrated approach, considering both genetic and other available biomarkers, will aid in creating clinically effective testing algorithms and cost-efficient biomarkers that improve the standard of care. Establishing access to national databases and a platform of cloud-based data sharing are of utmost importance to facilitate data sharing. We ask the EU to: - share best practice; - revisit its screening guidelines to increase screening rates, and provide structural support to achieve high levels of quality and effectiveness; - enable the implementation of VBHC and cross sectoral partnerships on health innovation to accelerate access to integrated care; and - promote fast track funding/reimbursement models for innovative solutions, - bridge resource constraints in MS with limited resources (via structural and cohesion funds). (See also attached pdf document with more information.)
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MedTech Europe urges longer PFOA transition for medical devices

5 Dec 2019
Topic — This consultation concerns the listing of PFOA under the EU POPs Regulation.
Message — MedTech Europe requests a time-limited exemption until 2030 for medical devices. This would avoid market disruption and allow for a properly enforceable substitution.12
Why — This allows companies to avoid immediate product bans and high compliance costs.34
Impact — Future patients lose access to life-saving technology if essential devices are discontinued.5
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Meeting with Rolf Carsten Bermig (Cabinet of Commissioner Elżbieta Bieńkowska) and SPECTARIS Deutscher Industrieverband für Optik, Photonik, Analysen- und Medizintechnik e.V. and

5 Sept 2019 · Medical Devices (Mr Bermig attended the meeting organized by Commissioner Oettinger)

Response to European Partnership for innovative health

26 Aug 2019

The proposal for the European Partnership on Innovative Health recognises the key impact of the European Health industrial sector, including medical technology, as a strong driver for innovation, economic and social impact, growth and jobs. We support the problem definition and the proposal for an institutionalised partnership. This partnership pioneers a new way to develop people-centred health care innovations promoting collaboration among: - industrial sectors: diagnostics, medical devices, pharmaceuticals, vaccines, biotechs, digital technologies and services; - the whole value chain of stakeholders: industrial players, academics, research organisations, regulators, payers, healthcare authorities, healthcare professionals, carers – and patients and citizens at large. An institutionalised partnership is essential for this level of integration (which is unprecedented) and to reach the desired impact on patients and health systems. We recommend the option Institutionalised Partnership under Article 187 of the EU Treaty as it is the most effective way: - to connect to national priorities in the strategic process, - to ensure achievement of the desired impacts of the R&I partnership, including those related to regulatory or policy uptake, - to ensure continuous openness to new partners, - to ensure flexibility of implementation and regular adjustments responding to changing policy or market needs, - to assure quantitative and qualitative leverage effects, including on financial and non-financial contributions, visibility and positioning in the international context, incentivized R&I related risks of private sector investments, - to ensure best access to projects funded by R&I partnerships to the wider European industry and potential end-users, and an active and targeted dissemination, especially to Member States, Associated Countries, - to anchor R&I of Global Companies in EU member states and Associated countries and leverage on these big players for wider market access, product distribution with local job creation, - to organize a mutual long term commitment to integrate innovative SMEs in large and multinational projects, - to focus on digitization without losing sight of healthcare improvement objectives, - to progressively activate synergies with other Horizon Europe Instruments (EIC) or programmes (Digital Europe, ERDF) to accelerate time to market for key healthcare innovations. The European Medical Technology industry is ready to strongly support this initiative.
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Response to Common Specifications for the reprocessing of single-use medical devices

20 Aug 2019

MedTech Europe - the European trade association representing the medical technology industries, from diagnosis to cure - is pleased to submit input to this consultation. For ease of viewing, the consolidated technical comments received from our members are enclosed as single document. Beyond these technical comments, we would also like to suggest that the opening Article 1 (‘Subject Matter’) should contain a clear statement that the reprocessing activities referred to in Article 17(2) of the Medical Devices Regulation 745/2017 (“the MDR”) are outside the scope of this Commission Implementing Regulation. Article 1 of the draft Commission Implementing Regulation already states that the purpose is (only) to lay down rules for the application of MDR Article 17(3) and not 17(2). Nevertheless, when we consulted our members, it was not clearly evident to all companies' staff that this Commission Implementing Regulation applies only to reprocessing of single-use devices conducted by health institutions for their own in-house re-use, i.e., without further market circulation within the Union. Finally, while MedTech Europe is pleased to see progress on this important MDR Implementing Act, we regret that stakeholders were consulted on such a complex topic during the Summer vacation. We would be grateful if the Commission could ensure that future stakeholder consultations of this nature are better timed. Thank you.
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Response to European Electronic Health Record (EHR) Exchange Format

20 Dec 2018

MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health. Our members are national, European and multinational companies as well as a network of national medical technology associations who research, develop, manufacture, distribute and supply health-related technologies, services and solutions. The members of MedTech Europe are committed to working towards better interoperability of digital health products and technologies on the basis of open and international standards and specifications. Lack of Electronic Health Record (EHR) interoperability is a barrier to overcoming the fragmentation of the market for digital products and technologies, and to realising the potential of these solutions to transform the delivery of healthcare records in Europe. Given this fragmentation of the market and the special role of public policy in European healthcare systems, policymakers and healthcare authorities have a unique opportunity to enable and improve EHR interoperability. Because EHRs affect the provision of healthcare, a Member State competence in Europe, such decisions would normally fall on policymakers on the regional or national level. To advance the European Digital Single Market, these specifications ought to come from the European Union. Therefore we welcome the intention of the European Commission to specify an Electronic Health Record Exchange Format (EHRxF) for the cross-border transfer of EHRs, as this marks an important economic and political step towards a better alignment of the roles of the European Union, the Member States and the healthcare organizations. In this context, we welcome that for the EHR Exchange Format the European Commission will collaborate with the eHealth Network and will rely on the technical competence and expertise assembled in eHAction, the Joint Action to support the eHealth Network. Given the medtech industry’s interest to work in a framework of global standards, we trust that working with national technical experts will mean the EHRxF will include European and international specifications, including the relevant profiles of Integrating the Healthcare Enterprise (IHE) and the standards for clinical and administrative data specified by Health Level Seven (HL7). It is important to highlight that patients and citizens should have meaningful control over their health data including their EHR, and that, considering the ageing population, programmes to facilitate the exchange of health data should be accompanied by appropriate educational programmes. MedTech Europe stands ready to support the European Commission in this undertaking and look forward to working towards making the promise of digital health a reality for Europe.
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Meeting with Manuel Nobre Goncalves (Cabinet of Commissioner Carlos Moedas)

15 Jun 2018 · Future closer collaboration and FP9

Meeting with Vytenis Andriukaitis (Commissioner) and

15 Jun 2018 · HTA

MedTech Europe backs renewing chemical exemptions for medical devices

15 Mar 2018
Topic — This consultation reviews environmental exemptions for lead used in specific glass applications.
Message — The association supports the renewal of all current exemptions for medical technologies. They argue these are crucial for continued supply as there is a lack of safe alternatives.123
Why — Renewals help manufacturers avoid costly product re-validations and delays in reaching the market.45
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MedTech Europe urges renewal of critical medical device exemptions

15 Mar 2018
Topic — A consultation on renewing environmental exemptions for lead solders in semiconductor connections.
Message — MedTech Europe supports the renewal of RoHS exemptions to ensure the continued supply of medical technologies. They state that the industry currently lacks safe alternatives that meet performance requirements.12
Why — Renewing these exemptions prevents costly re-validation of products and market approval amendments.3
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MedTech Europe Backs Lead Exemption Extension for Medical Devices

15 Mar 2018
Topic — A consultation on extending lead-related environmental exemptions for medical technology components.
Message — MedTech Europe supports renewing environmental exemptions for several medical device applications. They argue that safe and performant alternatives for these technologies are currently unavailable.12
Why — Maintaining these exemptions avoids costly product re-validations and market approval delays.34
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MedTech Europe Urges Renewal of Medical Device RoHS Exemptions

15 Mar 2018
Topic — This consultation addresses renewing exemptions for cadmium use in medical device electrical contacts.
Message — MedTech Europe supports renewing all current exemptions and specific expiry dates for medical devices. They argue that safe and performant alternatives for these specific applications are currently unavailable.12
Why — This extension prevents costly re-validation of products and maintains stable investment planning.34
Impact — Environmental advocates lose as toxic heavy metals persist within medical equipment manufacturing.5
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MedTech Europe backs lead exemptions for medical device diodes

15 Mar 2018
Topic — EU consultation on renewing lead exemptions for plating layers in certain diodes.
Message — The organization supports renewing exemptions to ensure the continued supply of medical technologies. They argue long transition periods are needed because safe alternatives are currently unavailable.123
Why — This would help manufacturers avoid high costs associated with product re-validation.4
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MedTech Europe backs renewal of medical device substance exemptions

15 Mar 2018
Topic — This consultation addresses extending exemptions for lead usage in medical device components.
Message — MedTech Europe supports the proposed renewal of all RoHS exemptions currently under consultation. They emphasize that there is a lack of safe and available alternatives that are equally performant for medical technologies.12
Why — Renewing these exemptions allows manufacturers to avoid costly product re-validation and market delays.34
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MedTech Europe Urges Renewal of Lead Exemptions for Medical Devices

15 Mar 2018
Topic — The consultation reviews the renewal of lead use exemptions in electronic medical device components.
Message — The group supports renewing exemptions to ensure the continued supply of medical technologies. They argue that a lack of safe alternatives necessitates long transition periods for compliance.12
Why — Renewing the exemptions allows the industry to avoid expensive re-validation and regulatory approval hurdles.34
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MedTech Europe backs RoHS exemption renewals for medical devices

15 Mar 2018
Topic — The consultation concerns renewing RoHS exemptions for lead and cadmium in glass enamels.
Message — MedTech Europe supports renewing RoHS exemptions, citing a lack of safe and available alternatives. They request long transition periods to ensure the continued supply of medical technologies.123
Why — Renewals would help manufacturers avoid expensive re-validation and regulatory approval update costs.4
Impact — European patients suffer if new medical technologies are delayed due to restricted substance use.5
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Meeting with Agnieszka Drzewoska (Cabinet of Commissioner Elżbieta Bieńkowska), Rolf Carsten Bermig (Cabinet of Commissioner Elżbieta Bieńkowska)

8 Nov 2017 · Strategic public procurement oraz HTA co-operation

Response to Codes for the designation of Notified Bodies in the field of medical devices and in vitro diagnostic medical devices

25 Oct 2017

MedTech Europe is pleased to submit comments for the draft Implementing Regulation which will set out codes for notified bodies in the field of medical devices (MD) and in vitro diagnostic medical devices (IVD). Our comments relate to both Annex I and Annex II. Please find our comments attached.
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