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European Coordination Committee of the Radiological, Electromedical and healthcare IT Industry

COCIR

COCIR is the European trade association for the medical imaging, health ICT, and electromedical industries.

Lobbying Activity

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)

28 Nov 2025 · Exchange on matters related to the interplay between the medical devices regulations and the AI Act and on the upcoming conference on medical devices.

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

27 Nov 2025 · Exchange of views on the current state of play of the medical devices Regulations reform proposal and discussion on the organisation of a conference on medical devices on the 16th of March 2026.

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

19 Nov 2025 · Exchange on the upcoming targeted revision of the EU rules for medical devices and in vitro diagnostics.

Meeting with Petra Nemeckova (Cabinet of Executive Vice-President Teresa Ribera Rodríguez)

6 Nov 2025 · Competitiveness of the Medical Technology Sector.

Medical imaging industry urges removal of circularity barriers

5 Nov 2025
Topic — EU Circular Economy Act aims to promote sustainable production and circular business models.
Message — The industry requests legal reforms to enable refurbishment and reuse of medical devices. They seek changes to waste, chemicals, and procurement rules that currently block circular practices. They want recognition for importing and refurbishing CE-marked devices without meeting current regulations.123
Why — This would allow them to refurbish and resell used equipment currently blocked by regulations.45
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Medical device industry urges AI Act exemption and EHDS clarity

14 Oct 2025
Topic — EU digital simplification covering AI regulations, health data rules, and regulatory overlap.
Message — Move AI-enabled medical devices from general high-risk AI rules to sector-specific oversight under existing medical device regulations. Extend the August 2027 AI Act deadline until key prerequisites are met, and protect devices developed before August 2024 from retroactive compliance. Provide clear guidance on structured health data and exclude legacy devices from Data Act obligations.12345
Why — This would avoid duplicate regulatory obligations and prevent market disruption for proven devices.67
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Meeting with Axel Hellman (Cabinet of Commissioner Jessika Roswall) and Siemens Healthineers AG and GE HealthCare Technologies Inc

14 Oct 2025 · Challenges in the supply chain for medical imaging devices Regulation of hazardous substances and their impact on competitiveness of the medical device sector

Meeting with Axel Hellman (Cabinet of Commissioner Jessika Roswall)

14 Oct 2025 · Circular Economy Act

Meeting with Hanna Anttilainen (Cabinet of Executive Vice-President Stéphane Séjourné)

14 Oct 2025 · Challenges faced by the medical devices industry

Medical imaging industry urges structural reform of EU device regulations

3 Oct 2025
Topic — Simplification of EU medical device and in vitro diagnostic regulations.
Message — COCIR requests eliminating the five-year recertification requirement, establishing centralized governance for medical devices, and introducing structured pre-submission dialogues with notified bodies. They seek simplified clinical validation requirements and dedicated pathways for innovative technologies addressing unmet clinical needs.1234
Why — This would reduce recertification costs and speed up market access for medical imaging devices.56
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Meeting with Maya Matthews (Head of Unit Health and Food Safety) and MedTech Europe

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

COCIR urges alignment of EU data rules for healthcare

20 Jul 2025
Topic — The consultation seeks to create a coherent legal framework for EU-wide data sharing.
Message — COCIR calls for a phased roadmap and alignment of the EHDS, Data Act, and AI Act. They request clear definitions for structured data and the use of proven international standards.12
Why — Alignment would reduce administrative burden and protect sensitive intellectual property from unintended exposure.34
Impact — Third parties lose access to raw sensor data if stricter intellectual property protections are applied.5
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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 Sandra Gallina (Director-General Health and Food Safety) and

24 Jun 2025 · EU medical device regulation and policy.

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 Andreas Glück (Member of the European Parliament)

11 Jun 2025 · Medical Devices

Medical device industry urges sector-specific AI regulation to avoid duplication

4 Jun 2025
Topic — EU strategy to accelerate AI adoption and strengthen competitiveness across strategic sectors.
Message — The organization requests moving medical devices from horizontal to sector-specific AI regulation, integrating AI Act requirements into existing MDR/IVDR frameworks. They seek to extend AI Act timelines from 2027 to 2029 to allow transition.123
Why — This would eliminate duplicate compliance processes and speed market access for AI medical devices.456
Impact — Patients face potential delays in AI safety oversight during the extended transition period.7
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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.

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

20 Mar 2025

Eight years into the EU Regulations for medical devices and in vitro diagnostics (MDR/IVDR), structural challenges regarding the governance system have become apparent. These challenges relate to a lack of clear accountability, transparency, and involvement of stakeholders. Moreover, the governance system misses a captain of the ship who has the explicit responsibility and accountability for ensuring the timely availability of legacy and innovative MDs and IVDs to patients and health systems. Without the leadership of an empowered central structure, there is no mechanism to course-correct shortcomings or to promote the EU regulatory system globally. This structural weakness has a concrete impact on the practical implementation of the legal frameworks. It creates diverging and unpredictable practices and fragmentation and thus leads to inefficiencies, high costs and delays in bringing medical technologies on the market in Europe. This situation needs to be addressed urgently in order to restore Europes attractiveness and competitiveness for medical technologies. The primary and ultimate goal of the European regulatory systems should be to make a broad range of safe and performing existing and innovative MDs and IVDs promptly available to patients, health care professionals and health systems, taking into account the medical needs of today and the future. The governance system should be designed to fully support this objective in the most efficient, predictable and transparent way possible and with a mind-set that promotes innovation and innovation ecosystems for developers of medical technology solutions in Europe. The medical technology industry proposes that the governance of the MDR and IVDR should evolve based on the following principles: 1. Key tasks and responsibilities should be centralised under a new single structure. This new central governance structure should be patient-centric. Its core priority should be to ensure the timely availability of safe and performing devices for patients, healthcare professionals and health systems as well as to strengthen the innovation capacity and the competitiveness of the medical technology sector. 2. The central governance structure should be accountable for the smooth functioning of the MDR and IVDR regulatory systems. In this respect, it should ensure transparent and predictable procedures and the alignment and coherence with other horizontal EU legislation applicable to the medical technology sector. 3. The decentralised Notified Body system is still needed and should remain a core pillar of the future regulatory system. The new central structure should improve time, costs and predictability of Notified Body services. 4. An empowered mandate, mission and vision, well defined roles and responsibilities, and an appropriate expertise for the broad range of MDs and IVDs are indispensable for a well functioning new future central governance structure. 5. An impact assessment regarding the main organizational options should be conducted with the aim of selecting one in which a new central structure can: a) deliver on its mandate and responsibilities, ensuring the fulfilment of the objectives of the IVDR and MDR including a sustainable, robust regulatory system which promotes innovation while ensuring a high level of patient safety b) has sufficient budget and empowerment to carry out its mission c) be sufficiently staffed to carry out its mission with expertise and experience specific to each MDs and IVDs d) ensure predictable and transparent processes, and reduce complexity, administrative burden and ultimately costs e) provide for early and continuous dialogue, collaboration and feedback between economic operators, regulators and Notified Bodies f) be time and cost effective and overall decreasing time and costs of managing the regulatory system and certifying of devices.
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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)

Meeting with Aurel Ciobanu-Dordea (Director Environment)

18 Feb 2025 · Discussion on REACH and RoHS and their interaction with medical imaging devices

Meeting with Andreas Glück (Member of the European Parliament)

12 Feb 2025 · Health

Industry groups urge longer RoHS lead exemption periods

10 Feb 2025
Topic — EU consultation on extending lead exemptions in electrical and electronic equipment components.
Message — Industry requests aligning expiry dates with past decisions, allowing at least two to five years after publication. They oppose complex rewordings and new footnotes that increase bureaucratic burden without technical justification.12
Why — This would reduce bureaucratic burdens and prevent sudden product bans across the single market.34
Impact — Environmental health protections are weakened by delaying the phase-out of lead in electronic components.5
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Industry coalition urges longer deadlines for lead use exemptions

10 Feb 2025
Topic — A consultation regarding time-limited exemptions for lead used in electrical equipment.
Message — The group requests extending lead exemption expiry dates to two years after publication. They claim splitting exemptions adds burden and forces changes based on bureaucracy.12
Why — This would reduce compliance costs and prevent many products from being banned.34
Impact — Children and the environment lose protections if lead safety restrictions are removed.5
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Medical technology groups urge longer RoHS lead exemption periods

10 Feb 2025
Topic — The consultation reviews lead exemptions for electronic components under the RoHS Directive.
Message — The industry group requests extending proposed expiry dates to at least two to five years after official publication. They oppose splitting exemptions into sub-categories, arguing this creates unnecessary bureaucratic burdens without technical justification. They also reject adding footnotes that duplicate other chemical regulations, which could immediately ban specific electronic products.123
Why — Extending these exemptions reduces administrative costs and prevents the immediate withdrawal of vital equipment.45
Impact — Consumers may lose access to products like electronic keys due to uncoordinated regulatory changes.6
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COCIR urges reduction of regulatory burdens on medical technologies

15 Jan 2025
Topic — A consultation aimed at removing single market barriers to help companies scale.
Message — COCIR calls for the removal of redundant reporting obligations and the streamlining of overlapping horizontal regulations. They advocate for longer transition periods that match the long design cycles of medical equipment. Finally, they suggest better coordination between EU departments to avoid duplicate data collection requests.123
Why — Streamlined rules would lower compliance costs and allow companies to reinvest in research.45
Impact — European patients lose out as companies prioritize launching new technologies in non-EU markets.678
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Meeting with Laurent Muschel (Acting Director-General Health Emergency Preparedness and Response Authority)

28 Nov 2024 · Courtesy meeting

Meeting with Stine Bosse (Member of the European Parliament, Committee chair)

4 Nov 2024 · European health policy

Meeting with Roberto Viola (Director-General Communications Networks, Content and Technology)

23 Oct 2024 · Digital health

Meeting with Tiemo Wölken (Member of the European Parliament) and Biomedical Alliance in Europe

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

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

COCIR urges expanded EU-Canada cooperation on medical devices

11 Apr 2024
Topic — Evaluation of the EU-Canada Comprehensive Economic and Trade Agreement after five years.
Message — COCIR recommends expanding the regulatory dialogue to include medical devices and accessories. They suggest enhancing cooperation under CETA Chapter 21 to improve recognition of audits.123
Why — This would lower administrative burdens and accelerate market access for European businesses.4
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Health tech trade body COCIR urges longer chemical data timelines

3 Apr 2024
Topic — Proposal to transfer RoHS scientific and technical tasks to the European Chemicals Agency.
Message — Industry calls for a mandatory one-year period to gather data before chemical consultations begin. They also advocate for face-to-face meetings to resolve conflicting stakeholder information.123
Why — This provides more time for technical studies and prevents restrictions based on unverified evidence.456
Impact — Environmental groups may face delays in banning toxic substances due to extended industry timelines.78
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Response to Evaluation of Standardisation Regulation (EU) No 1025/2012

28 Sept 2023

In the context of the ongoing evaluation of Regulation 1025/2012 on European standardization, COCIR would like to highlight the following considerations and recommendations. Regulation 1025/2012 is still fit for purpose. Therefore, we recommend avoiding any revision of the Regulation at this stage. At the same time, we recognize the need for an improvement of specific provisions of Regulation 1025/2012, especially Article 10(5). In particular, we believe that there is significant room for improvement with respect to the practical implementation of Article 10(5) and its impact on the complex system of HAS Consultants and related processes to assess whether a harmonized standard meets the expectations and can be published in the EU Official Journal. Overall, the current implementation of Article 10(5) is perceived as an obstacle to the well-functioning of the European Standardization System, and it creates serious risks on its global relevance in the future. In particular, we already observe a negative impact on the engagement of experts in the European Standardization System processes. Specifically, experts struggle with the formal and sometimes even technical issues identified by the HAS consultants which eventually hinder the publication of globally accepted safety standards in the Official Journal of the EU. Therefore, we would welcome the development of measures supporting the implementation of Article 10(5) in a way that facilitates the adoption of the comprehensive set of safety standards developed by IEC and ISO at EU level. Furthermore, we take the chance to underline that the voting rules of IEC and ISO ensure a strong European voice at IEC and ISO level. This ensures that requirements originating from the EU can become part of IEC and ISO standards without any additional need for regulations. Therefore, facilitating the adoption of IEC and ISO standards would strengthen the European Standardization System and leverage its role also at the international level.
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COCIR urges delay in expanding EU sustainable investment rules

3 May 2023
Topic — This initiative establishes classification criteria for environmentally sustainable economic activities across the European Union.
Message — COCIR requests postponing the taxonomy's expansion to ensure reporting quality and manageable administrative workloads. They argue medical devices should be exempt when environmental rules conflict with safety or performance.12
Why — Postponing the requirements would reduce the immediate reporting burden on medical device manufacturers.3
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COCIR urges EU to avoid overlapping cybersecurity regulations

23 Jan 2023
Topic — The consultation addresses mandatory cybersecurity requirements for all products with digital elements.
Message — COCIR wants the Act to respect existing medical device laws. They request that new rules exclude products already on the market. They also want refurbished goods excluded.123
Why — This would prevent costly duplicative compliance processes for healthcare manufacturers.45
Impact — Patients may face risks from older products that remain exempt from modern security standards.67
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Response to Mid-term evaluation of the Recovery and Resilience Facility (2020 – 2024)

6 Dec 2022

The Recovery & Resilience Facility (RRF) makes 672.5 billion in grants and loans available to EU Member States until 2024. As outlined in COCIRs recommendations in April 2021, a lack of capacity at various stages of national healthcare systems became apparent during Covid-19. Unforeseen external shock factors showed a lack of flexibility and pandemic preparedness. In the attached document, we are glad to provide our members concrete experiences during the implementation of this historic programme as part of the evaluation process.
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Response to EU strategic Framework for Global Health

19 Sept 2022

In addition to our contribution to the public consultation, COCIR – the European Trade Association representing the leading industries in the medical imaging, radiotherapy, electromedical, and health ICT sectors – supports in principle the European Commission's initiative to develop a strategy that will help the EU fulfill its global role as a promoter of world-wide resilience and sustainability in healthcare. Large-scale health challenges, such as pandemics, the climate change effects on biodiversity, and the evolution of infectious and non-communicable diseases – NCDs – neither can nor should be tackled with unilateral actions. A European multilateralism strategy could effectively promote global health objectives and help improve the global systems’ resilience through the uptake of e-governance and digital health solutions. Τools, such as knowledge transfer from the EU to third countries, could in principle promote growth and global health objectives, provided that the EU will in parallel create a roadmap on how to practically achieve this without jeopardising its competitiveness and know-how. COCIR, together with its members, will continue to contribute to this European Commission initiative, providing our full support. Moreover, we call on the European Commission to organise a specific stakeholder consultation with our member industries and look forward to becoming informed on the results and planned next steps.
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Response to Reclassification of certain active devices without an intended medical purpose

7 Sept 2022

COCIR appreciates the opportunity to provide feedback to the European Commission’s proposal for an Implementing Regulation laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose. While we support the Implementing Regulation’s objectives to ensure that such devices are classified in accordance with their risks, we believe that the intended use of the device, as prescribed by Article 51 of Regulation (EU) 2017/745, should be further considered in the formulation of the proposed classification risk laid out in this Regulation. Please find here a number of recommendations to further improve the framework, in view of future application and implementation: • Application of the principles established by Regulation (EU) 2017/745 Article 51 and MDCG 2021-24 - i.e., the intended use and the type of technology - in the classification of treatments as “potentially hazardous”. We note that for products of Section 4 of Annex XVI to Regulation (EU) 2017/745, the Implementing Act Recital 6 considers side effects to this purpose. • Manufacturers to justify whether their devices are potentially hazardous or not. Grouping different types of devices - whose technology and intended use differ - in one group would not provide a realistic picture. For instance, listed side effects for products of Section 4 of Annex XVI to Regulation (EU) 2017/745 (Implementing Act Recital 6) do not apply to all mentioned products. As such, risks of devices for lipoplasty or liposuction which are intended to surgically invade the body cannot be equally compared to devices non-ablative and non-invasive. • Whereas devices with an intended medical purpose may carry a higher risk than their Annex XVI counterparts, the opposite situation – where non-intended medical purpose devices are associated to a higher risk – is not applicable nor desirable. Specifically, we refer to the proposed upgrade of class risk (to class IIb) for high intensity electromagnetic radiation emitting equipment as referred to in Section 5 of Annex XVI to Regulation (EU) 2017/745 that is intended for the use on the human body for skin treatment. According to MDCG 2021-24, devices regulated by Rule 9 – and specifically phototherapy for skin treatment – are classified as class IIa. In those cases where medical and Annex XVI pulsed light (‘IPL’) equipment are technically identical*, we advocate for maintaining the same class risk. Additionally, we would appreciate further clarification on the application of Article 1(a) and 1(b) for home use devices – e.g. will skin rejuvenation be included as intended use for home use devices? We also enquire what type of impact the upgrade from class I to class IIa could have on the use of some equipment in section 5 Annex XVI by non-professional users, such as beauticians or figures in the beauty sector. Finally, we recommend that decisions on the upgrade of products from risk class I to IIa take into account: a) The impact on Notified Bodies capacity and workload, also in light of the current discussions and the recommendations of the position paper MDCG 2022-14 . b) The proposed transitional provisions in the draft Commission Implementing Regulations on Common Specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745. In particular, we would like to avoid that prolonged certification procedures could overlap with (and affect) the time allowed for the transition of those products. *COCIR companies can provide technical evidence in support of this statement
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COCIR urges legal alignment for European Health Data Space

27 Jul 2022
Topic — The consultation addresses rules for sharing health data across the European Union.
Message — COCIR requests that the EHDS regulation be aligned with GDPR to ensure legal certainty. They also seek protection for intellectual property and want industry experts included in consultations.123
Why — Aligning these rules would reduce compliance risks and protect corporate intellectual property.45
Impact — Vague definitions of data systems threaten to increase costs for national healthcare systems.6
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Health tech group COCIR seeks to narrow Data Act scope

12 May 2022
Topic — The EU Data Act creates rules for sharing data between businesses and governments.
Message — COCIR requests narrowing the data definition to protect intellectual property and trade secrets. They propose extending the transition period from 12 to 48 months for compliance.12
Why — This would protect proprietary manufacturing secrets and significantly reduce immediate compliance burdens.3
Impact — Researchers and third-party service providers would lose access to valuable machine-generated diagnostic data.4
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Response to Single Market Emergency Instrument (SMEI)

11 May 2022

Please find the COCIR contribution hereby attached.
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Response to European chips act package – Regulation

9 May 2022

Please find our feedback attached.
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Meeting with Malte Gallée (Member of the European Parliament, Shadow rapporteur) and European Recycling Platform SAS

21 Apr 2022 · Batteries Regulation (staff level)

Medical Tech Group Urges Proportionality in EU Chemical Rules

12 Mar 2022
Topic — EU review of rules restricting hazardous substances in electrical and electronic equipment.
Message — They seek a simpler exemption process using proportionality for essential medical equipment. They also propose a legacy approach for spare parts to ensure device availability.123
Why — Companies would avoid high costs by not redesigning old models for negligible benefits.45
Impact — Environmental advocates lose as some hazardous chemicals remain in the supply chain longer.67
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Response to Cancer Screening Recommendation

9 Feb 2022

The COCIR feedback can be found in the attachment. Thank you.
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Response to Smartwatches and connected toys

27 Aug 2021

We appreciate the opportunity to provide our feedback to the draft Delegated Regulation under Article 3(3), points (d), (e) and (f) of the Radio Equipment Directive. Our detailed comments can be found in the attached.
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Medical technology industry warns against new AI liability rules

28 Jul 2021
Topic — EU proposal to adapt civil liability rules for AI-enabled products and services.
Message — The organization requests that existing medical device regulations be recognized as sufficient for AI liability. They argue new rules would create a fragmented legal landscape and undermine sector-specific accountability frameworks already in place.123
Why — This would allow them to avoid additional compliance costs and legal uncertainty beyond existing medical device regulations.45
Impact — Patients and consumers lose stronger protections if AI-specific liability gaps remain unaddressed by horizontal rules.6
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Response to Standardisation Strategy

23 Jul 2021

In healthcare, standards have an indispensable role for the proper functioning of medical devices, for correct transmission of information, and more. Thus, standards support manufacturers to produce medical devices and digital health technologies with constant high quality and help authorities to ensure that medical devices and digital health technologies provide the safety and performance required. COCIR gladly contributes our views to the roadmap for a European standardisation strategy. Our detailed views can be found in the attached document.
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Response to Revision of the Machinery Directive

20 Jul 2021

COCIR gladly provides our feedback to the proposal for a Machinery Regulation in the attached document.
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Medical technology group warns AI Act burdens healthcare innovation

2 Jul 2021
Topic — This consultation gathers feedback on safety and liability requirements for artificial intelligence systems.
Message — COCIR urges removing medical devices from the high-risk category to avoid regulatory duplication. They recommend aligning definitions with medical laws and relaxing data accuracy requirements. The group also requests extending the transition period to four years.123
Why — This would reduce compliance costs and prevent redundant regulatory hurdles.45
Impact — Patients may suffer if developers prioritize other markets with faster approval processes.6
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Response to Data Act (including the review of the Directive 96/9/EC on the legal protection of databases)

25 Jun 2021

COCIR welcomes the opportunity to provide feedback to the European Commission’s inception impact assessment for a Data Act. COCIR fully endorses the Commission’s view that the availability of and access to data holds immense potential for innovation and value creation, and that this will greatly contribute to the recovery and resilience of our society following the COVID-19 pandemic. Representing the health technology and innovation sector, COCIR is strongly convinced of the positive effects of the use of health data in the public interest. The Data Act can be a valuable tool, complementing other existing frameworks in support of a European Single Market for data and the creation of a European Health Data Space. With regard to business-to-government sharing, first and foremost there should be strong adherence to the GDPR and ePrivacy. Coherence should also be ensured with the ongoing initiatives proposed under the European Health Union package that seek to gather more data linked to health threats. Requests for data should be reasonable and proportionate. A comprehensive impact assessment should be done before introducing any mandatory data access rights, taking into consideration the sector-specific context, including competition issues and market failures. At all times it should be made clear for which purposes and to which parties the data will be made available. Sharing mechanisms should take full advantage of automated means to share and exchange data, accommodating bulk transfers or providing data exchange through APIs. With regard to business-to-business sharing it is vital to underscore the voluntary nature of data sharing. Having said that, contractual fairness and clarity should be elemental to any B-2-B agreement. This could be further facilitated and instrumentalised through data sharing template agreements and licenses. With regard to rules on data access and usage rights COCIR fully supports the fair, reasonable, proportionate, transparent and non-discriminatory use of terms. We would like to stress however the legal uncertainty and complexity related to what constitutes personal and non-personal data, and how to deal with any mixed datasets. With regard to a competitive cloud market COCIR appreciates the evaluation of the current industry codes of conduct on data portability and service switching. This should lead to a strengthened framework that will offer European industry the infrastructure and services needed to develop new insights and technologies. . With regard to international access to data COCIR understands the need for safeguards and trust-building measures. It is however crucial that this does not lead to overly protectionist measures or data localisation measures, as this may inadvertently hamper or block international collaboration on research and innovation. Practical rules on data sharing and free flow of data between trusted parties (also non-EU) should remain the general principle.. COCIR remains fully committed to working with the European Institutions, the Member States and other involved stakeholders in creating a robust European data economy that will foster a competitive and innovative environment, leading to a stronger and more resilient EU economy and society. COCIR References COCIR contribution to the public consultation on the Data Governance Act (February 2021) COCIR response on the European Health Data Space (IIA) (February 2021) COCIR response on Open Data – Availability of Public Datasets (August 2020) COCIR response on the data governance framework of common European data spaces (July 2020) COCIR input on the European Strategy for Data (May 2020) About COCIR COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries.
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Response to Commission Implementing Regulation on EUDAMED

22 Jun 2021

COCIR appreciates the opportunity to provide feedback to the draft Commission Implementing Regulation laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed). Our detailed comments are included in the attached document.
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COCIR Calls for Simpler REACH Rules for Medical Technology

1 Jun 2021
Topic — Revision of EU rules for the registration, evaluation, authorisation and restriction of chemicals.
Message — COCIR requests a simplified authorisation process for essential medical technologies using small chemical quantities. They also advocate for rules allowing the reuse of spare parts to support device refurbishment.123
Why — This would reduce administrative burdens and stop engineering teams from being diverted from innovation.45
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Response to Electronic instructions for use for medical devices

25 May 2021

COCIR appreciates the additional opportunity to provide industry feedback to the draft Implementing Regulation on electronic instructions for use (IfU) under the Medical Device Regulation. In general, the availability of electronic IfU is wider than providing one hardcopy. Commonly used technologies provide means for full-text search which has a clear benefit for the usability of the Instructions for Use. The current e-IFU regulation is behind the times in terms of technology and the need to provide ease of access to information for clinicians. In addition, the adverse environmental impact of continuing to require paper manuals for the majority of devices in the EU is extremely wasteful and does not align with the conservation and waste reduction principles central to the EU. Clearly the future of Instructions for Use, for professional users or lay persons, lies within their electronic provision - independent of being embedded in the software as an online help system, or through separate means. Medical devices should by default be allowed to use e-IfU unless otherwise specified. It should be up to the manufacturer to decide if the Instructions for Use are provided electronically or on paper depending on their analysis of the device use, as long as it can meet all other risk assessment and other provisions within the e-IfU regulation. By following the existing risk management framework already built into the regulation, along with the provisions to ensure paper manuals are provided immediately to any customer who requests them, free of charge, the potential risks are well mitigated, and the regulation can better support the current workflow and expectations of clinicians in today’s environment. Our detailed feedback is described in the attached document.
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Meeting with Margaritis Schinas (Vice-President) and

8 Apr 2021 · Health Union

Response to Revision of the NIS Directive

18 Mar 2021

COCIR welcomes the opportunity to provide feedback to the European Commission’s proposal for a Directive on measures for a high common level of cybersecurity (hereafter the NIS 2 Directive proposal). COCIR appreciates that the NIS 2 Directive approval builds upon the strengths of the original framework and introduces additional measures to enhance the cybersecurity capacity and capabilities of Member States. Stronger built-in cooperation mechanisms will help improve the EU’s resilience and reinforce its regional power. From a market perspective however, things look quite different as the NIS 2 Directive proposal still leaves several flaws unaddressed, that might perpetuate or aggravate the existing legal fragmentation and overlaps with other regulatory frameworks The healthcare sector is already heavily regulated, especially when it comes to medical devices and medical software which will in the near future be covered by even more stringent requirements introduced by the Medical Device Regulation. The digital transformation of health and care has been ramping up in the past years, and certainly under influence of the COVID-19 pandemic crisis, this development has strongly accelerated. The importance and growth of digitalisation in the sector hasn’t gone unnoticed and clearly there is a critical need for appropriate cybersecurity and resilience measures. Cybersecurity in healthcare is however a shared responsibility between industry, healthcare providers, healthcare professionals and other stakeholders. COCIR fully supports and contributes to continuing efforts that raise the level of awareness and security within the sector, recognizing the importance of a secure supply chain. Having said that, COCIR would like to urge the European Commission to provide the necessary tools, guidance and possible templates – developed in cooperation with stakeholders, including industry – to ensure a smooth and harmonised exchange of information with authorities and within value chains. In general, COCIR would like to reiterate its call - To reduce legal fragmentation and create a level playing field - To provide legal certainty in more clearly articulating the scope, definitions and requirements - To ensure consistency with existing frameworks and avoid overlaps and administrative burden - To recognise the value of sector-specific approaches in order to define proportionate and risk-based measures - To take account of international and European developments in standardisation to define state of the art More detailed feedback can be found in attached document
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Response to Evaluation of patient rights in cross-border healthcare

11 Feb 2021

COCIR – the European Trade Association representing the leading industries in the medical imaging, radiotherapy, electromedical and health ICT sectors, fully supports this European Commission [EC] initiative to assess the performance of the Directives 2011/24 and 2012/52/EU. COCIR considers the EC effort timely and necessary. We urge the EC to promote solutions which enhance the simplification of administrative processes within and across Member States, in order to make cross-border care more accessible to citizens. COCIR is fully supportive of ERNs and encourages the extension of their scope to cover more diseases, such as more common types of cancer as has been proposed in the Europe’s Beating Cancer Plan. COCIR, together with its members, will continue to contribute to this European Commission initiative, providing our full support. Moreover, we call on the European Commission to organise a specific stakeholder consultation with our member industries and look forward to becoming informed on the results and planned next steps. Please refer to attached document for our detailed feedback.
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Response to Legislative framework for the governance of common European data spaces

8 Feb 2021

COCIR welcomes the opportunity to provide feedback to the European Commission’s proposal for a Data Governance Act. COCIR has in the past presented its views on the European Strategy for Data as well as on the inception impact assessment of a data governance framework for common European data spaces. COCIR fully endorses the Commission’s view that the availability of and access to data holds immense potential for innovation and value creation, and that this will greatly contribute to the recovery and resilience of our society following the COVID-19 pandemic. Leading the digital health innovation, COCIR and its members strongly believe in the crucial role the use and sharing of data plays in addressing the ongoing COVID-19 pandemic crisis, and the structural role the European Health Data Space will play in the further development of preventive and personalised healthcare, driving research and innovation, leading to better outcomes for patients and the society as a whole. Please refer to attached document for detailed feedback. In summary, COCIR considers the Data Governance Act proposal to be an important step in enabling common European data spaces, and in building trust with organisations and citizens. At the same time COCIR would like to caution on provisions that may jeopardise consistency and coherence with existing regulations and initiatives, especially the General Data Protection Regulation. The success of common European data spaces will further depend on the sector-specific context and frameworks that will need to be created. In this regard, COCIR is warmly welcoming the initiative of the European Commission to establish a legislative framework for a European Health Data Space and will in due time provide its expert feedback, drawing from its vast and long-term experience of improving care provision through innovative and digital health technologies. COCIR remains fully committed to working with the European Institutions, the Member States and other involved stakeholders in creating a robust data governance framework that will be able to support all common European data spaces, driving new opportunities for research and innovation and building a stronger and more resilient EU economy and society.
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Medical imaging industry urges harmonised health data rules across EU

3 Feb 2021
Topic — Regulation on the European Health Data Space for patient data sharing and research.
Message — The organization requests harmonized data protection rules across Member States to enable health data access and exchange. They argue fragmented GDPR implementation creates significant hurdles for machine learning and medical software development. They seek clarification that medical images without patient information should be considered anonymized data for scientific research.123
Why — This would reduce compliance burdens and enable companies to process large amounts of health data for AI development.45
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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

COCIR remains committed to working with the EU institutions and relevant stakeholders to create a clear robust and futureproof framework for transfers of personal data to third countries, in full respect of the fundamental rights and freedoms of EU citizens. Please find our comments in attached document. COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries.
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Response to Evaluation of the 'New Legislative Framework' for EU legislation on industrial products

2 Dec 2020

The New Legislative Framework (NLF), in support of the single European market for industrial products, is key to the competitiveness of European industry and to meet the European Union’s ambitions on the digital transformation of the European economy and sustainability of the European society. Overall, the provisions of the New Legislative Framework are still fit-for-purpose to meet the challenges of the 21st century. However, business models are evolving. Some changes in the use, interpretation and implementation of the New Legislative Framework may thus be necessary. A finely tuned NLF would allow new business models to flourish, bringing benefits to industry, environment and climate, healthcare and ultimately patients and citizens. COCIR welcomes the EC initiative to evaluate the NLF and will contribute actively to the studies detailed in the roadmap. Our more detailed recommendations for the aspects to consider in the evaluation can be found in the attached document. Summary of recommendations • The NLF should clarify that software is understood as to be placed on the market only once, even if transported on a physical medium. • Use of the New Legislative Framework to introduce new security requirements at product level should avoid overlapping / contradictory requirements between horizontal and sectorial legislations. • The NLF should enable as much as possible the use of eLabelling and electronic Instructions for Use. • CE marked medical imaging devices for professional use refurbished according to international standards, e.g. IEC 63077, should have to meet at least all the requirements that were in force at the time when the relevant Declaration of Conformity was issued – and re-distributing in the EU should not be dependent on where the product was marketed as a new product, inside or outside of the EU, under the provision it does not significantly impact safety and performance. • The "repaired as produced” principle should be incorporated in the NLF so that future EU legislation does not contain different or even conflicting approaches in this regard. This would help to ensure that the NLF provides a boost for the circular economy and not a barrier. • Reuse of components for the manufacturing of new devices should be considered in the evaluation of the NLF. • In the implementation of the NLF, the essential requirements / GSPRs should be worded at a generic level as originally intended. • A thorough assessment of the implementation of Regulation 1025/2012 with all relevant stakeholders (including industry) with the goal to streamline the harmonisation process, is necessary. • The NLF (and all derived sectorial legislation) should allow the possibility of conducting audits by Notified Bodies remotely, using the latest digital technologies.
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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

COCIR urges EU to use existing medical device rules for AI

10 Sept 2020
Topic — The European Commission is consulting on new ethical and legal requirements for Artificial Intelligence.
Message — COCIR argues against new regulatory frameworks for AI-based medical devices. They believe current medical and data protection rules already ensure safety, and suggest using voluntary codes and international standards instead.12
Why — The industry avoids the administrative costs and complexity of complying with new, overlapping regulations.34
Impact — Patients may face inconsistent safety standards if ethics oversight remains voluntary rather than mandatory.56
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Response to Implementing act on a list of High-Value Datasets

25 Aug 2020

COCIR welcomes the opportunity to provide feedback to the consultation on the availability of public datasets as provided for by Article 14 of the Open Data Directive. Public sector information is highly relevant for the healthcare sector and COCIR looks forward to the prospect of the availability of High Value Datasets in a European Health Data Space. COCIR is fully supportive of the principles laid down in the Open Data Directive with regard to the availability of High Value Datasets. In addition, COCIR would like to formulate following general principles for the availability of High Value Datasets: 1. High value datasets should imply high quality of the datasets 2. Availability of public datasets should work cross-border 3. Availability of datasets should come with minimal delay 4. Equal access to High Value Datasets for all actors and all sectors 5. Prior assessment and consultation with private sector partners in case of particular concerns COCIR recommends that the European Commission makes use of its delegated powers to include health information as a thematic category. COCIR would like to encourage the European Commission to include High Value Datasets, for instance on population health data, health system effectiveness and availability of healthcare resources. COCIR would like to emphasise the need for sufficient funding in order to create the appropriate conditions for availability of High Value Datasets. COCIR remains fully committed to work with the European Commission, the EU Member States and other relevant stakeholders to increase the meaningful use and re-use of public sector information in order to foster a competitive and strong European digital health sector, to support the resilience and capacity of health systems and to improve health outcomes for patients. Please refer to attached file for more detailed feedback. About COCIR COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries. Founded in 1959, COCIR is a non-profit association headquartered in Brussels (Belgium) with a China Desk based in Beijing since 2007. COCIR is unique as it brings together the healthcare, IT and telecommunications industries. www.cocir.org
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Response to Revision of the NIS Directive

12 Aug 2020

COCIR welcomes the opportunity to provide feedback to the combined roadmap and inception impact assessment on the revision of the Directive on Security of Network and Information Systems (NIS Directive) as published by the European Commission. Please refer to attached document for COCIR's response. COCIR remains fully committed to work with the European Institutions, the Member States and other involved stakeholders in addressing the identified challenges. About COCIR COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries. Founded in 1959, COCIR is a non-profit association headquartered in Brussels (Belgium) with a China Desk based in Beijing since 2007. COCIR is unique as it brings together the healthcare, IT and telecommunications industries. www.cocir.org
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Response to Legislative framework for the governance of common European data spaces

31 Jul 2020

COCIR welcomes the opportunity to provide feedback to the European Commission’s inception impact assessment on a legislative framework for the governance of common European data spaces. COCIR has presented its views on the European Strategy for Data and is fully supportive of the creation of common European data spaces, and in particular a European Health Data Space, which would greatly contribute to the development of preventive and personalised healthcare, driving research and innovation, leading to better outcomes for patients and the society as a whole. Please refer to attached file for the COCIR response to the consultation. About COCIR COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries. Founded in 1959, COCIR is a non-profit association headquartered in Brussels (Belgium) with a China Desk based in Beijing since 2007. COCIR is unique as it brings together the healthcare, IT and telecommunications industries. www.cocir.org
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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 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 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 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

Response to Report on the application of the General Data Protection Regulation

29 Apr 2020

COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries. Founded in 1959, COCIR is a non-profit association headquartered in Brussels (Belgium) with a China Desk based in Beijing since 2007. COCIR is unique as it brings together the healthcare, IT and telecommunications industries. www.cocir.org
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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 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 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

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 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 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 SANOFI and

6 Apr 2020 · Digitisation of healthcare and innovative e-health solutions.

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 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

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

Response to Europe’s Beating Cancer Plan

2 Mar 2020

Europe’s Beating Cancer Plan COCIR contribution to the EC Roadmap COCIR –the European Trade Association representing the leading industries in the medical imaging, radiotherapy, electromedical & health ICT sectors– welcomes this European Commission (EC) initiative of a cross-disciplinary Action Plan to effectively address cancer related challenges in Europe. We appreciate the opportunity to provide our feedback to the current roadmap and look forward to the upcoming targeted consultations between EC & stakeholders. The challenges identified in the Roadmap are accurate & recurrent in the activities of our industries. Cancer prevention and inequalities in access to cancer diagnosis & care – are deriving from diverging national healthcare schemes , personal & socioeconomic reasons . Here COCIR highlights the added value of imaging, image-guided therapies, such as radiotherapy, and digital solutions enabled by ICT across the entire continuum of cancer care5. COCIR supports the EC focus on early detection & diagnosis via regular screening. From this perspective, we call for the update of the 2003 Council Recommendations and a review of existing EU Screening Guidelines for breast , colorectal & cervical cancer & urgently elaborate new ones for other types of cancers, such as lung & prostate cancer. These efforts should be ideally combined with the provision of tangible incentivises for implementation at national level through, for example, Structural, Cohesion & Innovation Funds. We also consider long term investment is critical to develop innovative solutions to keep the leadership in research in Europe. With regards to cancer treatment it is important to note that there are proven alternatives to pharmaceutical and chemical therapies, such as surgery and radiotherapy as well as importance of digital-enabled solutions. Radiotherapy treatment is recommended for more than 50% of cancer patients as a core component of high-quality cancer care. Still, 25% of cancer patients across Europe could benefit from radiotherapy but do not receive it11. Lastly digital health technologies support better control & quality, improve efficiency & interoperability of workflows along the care pathway. In addition, Artificial Intelligence & Data Analytics contribute to more accurate & rapid detection, diagnosis and more personalised treatment of various cancers resulting in improved outcomes for better informed and more engaged patients . In this frame, a specialised EU Health Data and Knowledge Space for Cancer and/or an augmented European Reference Network scheme to include all types of cancer could be a topical solution. COCIR, together with our members, will continue to contribute to this European Commission initiative providing our full support. We call on the EC to organize a specific consultation with our industries.
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Response to A new Circular Economy Action Plan

20 Jan 2020

COCIR, representing the radiological, radiotherapy, healthcare IT and electromedical industry in Europe appreciates the possibility to provide its views on the roadmap for the new Circular Economy Action Plan (‘CE Action Plan’). COCIR supports the objectives of the CE Action Plan. COCIR Members are frontrunners in implementing a circular business model: refurbishment of medical imaging devices, a very advanced form of reuse and life extension, is an established practice for more than two decades. Today, “Good refurbishment practices for medical imaging equipment” is an international standard, the IEC 63077. Based on more than 20 years of experience, COCIR Members notice that the Circular Economy initiatives of the EU so far, starting from 2015, have not yet fully untapped the potential of reuse – such as refurbishment and upgrading - and kept the focus on waste prevention and recycling. It has been already recognized by the Waste Framework thatreuse or waste prevention should be prioritized over recycling and that a recycling economy is still very far away from a circular one. COCIR is therefore very glad to finally see a clear reference to prioritisation of reuse: It will set minimum requirements to prevent environmentally harmful products from being placed in the EU market and identify options to prioritise reuse and repair before recycling. COCIR would like to clearly underline that any action of the EU with the aim to prioritize reuse and repair should carefully consider that: 1. Reuse and repair in the B2B sector, in particular for capital investment equipment such as medical imaging devices which are for professional use only, is a completely different field than consumer products. A one-size-fits-all approach would not work and would potentially have negative consequences on the B2B activities, such as refurbishment of medical imaging devices. COCIR suggests that any future measures/guidelines should take into account the specificities of each sector. 2. Reuse of equipment in the B2B sector is as important as the reuse of spare parts for servicing, repair and maintenance of installed equipment. Reusing recovered parts has an incomparably lower environmental impact than manufacturing new ones. Nonetheless, most of EU chemical legislation goes the opposite direction rather than favouring this activity. .......................................
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COCIR warns PFOA restrictions threaten medical device availability

3 Dec 2019
Topic — The consultation addresses the restriction of PFOA under the EU POP Regulation.
Message — COCIR requests a minimum five-year exemption for medical imaging and radiotherapy equipment. Currently proposed timelines are technically impossible for complex global supply chains.12
Why — An extended deadline avoids high redesign costs and preserves existing product lines.3
Impact — European patients risk losing access to critical diagnostic tools and cancer treatment systems.4
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Response to Evaluation of investments in information and communication technologies supported by the ERDF in the period 2007-2013

5 Sept 2019

COCIR takes the opportunity of the publication of this Roadmap to congratulate the Commission to commit to an ex post evaluation on investment projects targeting the provision of information and communication technologies (ICT) by the European Regional Development Fund (ERDF) during the period 2007-2013. Cohesion Policy funding, such as the European Regional Development Funds, is crucial to assist EU Member States in improving the quality, accessibility and sustainability of their healthcare systems and to contribute to the growth and job creation across the European Union. Increasing societal challenges and current public expenditure cuts require smart and cost-efficient solutions. Innovative medical technologies, including Information and Communication Technologies, are bridging the quality-cost gap and leading the change towards a more integrated approach. COCIR, the leading EU trade association on medical technologies, representing the European Radiological, Electromedical and Healthcare IT industries, calls onto the EU institutions to further support investment in the healthcare sector, such as investment in infrastructure (including digital infrastructure) and the uptake of services through continued and smarter use of European Regional Development Funds. Investments in innovative medical solutions through an effective use of the EU funds are crucial to reduce inequalities within and between EU Member States and to balance the cost-quality factor in health services. COCIR believes Cohesion Policy funds should be used to make sure that access to healthcare does not depend on which region European citizens live in. EU funding is also crucial to further engage regions in the achievement of the health-related Europe 2020 strategy initiatives, such as the Active and Healthy Ageing Innovation Partnership (AHAIP) and the Digital Agenda for Europe. COCIR recommends the European Commission and the EU Member States to apply where relevant the learnings of the ex post evaluation as an essential input for the development and roll-out of other EU investment programmes, such as the Connecting Europe Facility (CEF), Horizon Europe the Digital Europe and Cohesion and Values programmes. COCIR is looking forward to contribute to the upcoming consultations as identified in the Roadmap along the years 2020 and 2021.
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Response to European Partnership for innovative health

27 Aug 2019

COCIR is glad to provide our feedback to the European Commission’s roadmap towards a Partnership for Innovative Health under Horizon Europe. European Commission has clearly identified the challenges that Europe is facing in the healthcare arena. The future Partnership could be a unique model for radical collaboration with extensive impact and benefits for all parties involved in the healthcare system. Patients will receive better, more personalised care. Integrated pathways will ease the burden on carers. Healthcare professionals will be able to deliver streamlined care that addresses their patients’ real issues. Companies will get access to new innovative solutions from cross-sector collaboration; they will get appropriate rewards for innovation that creates value; and technology will be de-risked. Payers will get better outcomes and better value. The society will benefit from healthier citizens and more effective healthcare systems. Finally, the whole ecosystem – on which all these players depend – will be more effective and sustainable. This novel Institutional cross-sectorial partnership for health research and innovation should bring together industry players from the entire value chain (large, mid-caps and small companies, including SMEs), the relevant academics, research organisations, regulators, payers, healthcare authorities, healthcare professionals, carers – and patients and citizens at large. Industry’s contribution will be a combination of expertise (spanning the fields of regulation, technology, science, cybersecurity and quality assurance), clinical development programmes, structured high-quality data and data platforms, equipment and prototypes. We applaud especially the increased focus on digitisation of the new partnership as the area where our members can make their strongest contribution. The role of our industry is in providing digital technologies to connect and integrate data sources to turn data into patient centric information. The combination of different knowhow will enable us to focus on learning healthcare systems predicting real needs; optimising the health journey for patients and de-risking innovation by providing solutions enhancing predictability. Our aim is to break down the silos between the different players, workflows and to accelerate the development of people-centred health care innovations for unmet public health needs. Our detailed feedback can be found in the attached document. We hope that all EU institutions will fully support this unique opportunity. COCIR has gladly contributed to the on-going discussions and is looking forward to further collaboration with other industry sectors, European Commission, member states and relevant stakeholders.
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Response to Common Specifications for the reprocessing of single-use medical devices

20 Aug 2019

COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries. We appreciate this opportunity to provide feedback to the draft Implementing Regulation for Single-use medical devices - safety and performance requirements for reprocessing. This is a critical period for the entire medical devices industry and regulatory system. It is crucial that secondary legislation, including implementing acts, guidance documents and Harmonised Standards, will be ready on time to allow industry to prepare and diligently implement the Medical Device Regulation. We are thus glad that progress is made on this important element of the implementation. We have reviewed the draft document and outline in the attached document the detailed aspects that require clarification as well as our proposals for improvement. COCIR is ready to discuss any remaining questions with the European Commission and member states.
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COCIR urges specific RoHS review for medical imaging sector

9 Oct 2018
Topic — Evaluation of EU rules restricting hazardous substances in electrical and electronic equipment.
Message — COCIR recommends a specific assessment for medical imaging devices because current rules ignore unique business models. They want the evaluation to identify actions reducing impacts on innovation and the circular economy.12
Why — These changes would reduce legal uncertainty for long-term research investments and boost refurbishment sales.34
Impact — Patients and healthcare systems lose access to advanced technologies due to regulatory barriers.5
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Meeting with Rolf Carsten Bermig (Cabinet of Commissioner Elżbieta Bieńkowska)

28 Aug 2018 · MDR implementation

Response to Multiannual Financial Framework – European Social Fund Plus (ESF+)

27 Jul 2018

COCIR welcomes the European Commission´s proposals for the next financial period 2021-2027, which put efforts towards simplifying and making the use of the EU Cohesion and Values Funds for the health sector more flexible. This contribution outlines key recommendations, which COCIR considers essential for the delivery of sustainable and high-quality health and care. These recommendations focus on the EC legislative proposals on the EU Cohesion and Values programmes (including the European Regional Development Fund -ERDF, Cohesion Fund -CF, and the European Social Fund Plus -ESF+), identified below and developed in the enclosed position paper. 1. The EU Cohesion and Values Funds should be made available to invest and encourage the scaling up of innovative healthcare and ICT technology solutions leading to better patients’ health and Europe’s healthcare system´s efficiency and economic recovery. 2. The European Commission should develop a robust framework of indicators relevant to access issues, which can be tailored to national and regional contexts. It is crucial for these indicators to measure access to medical technologies, which support diagnostic imaging, radiotherapy services, Digital Health, and Health ICT. 3. The European Commission should encourage and incentivise EU Member States to cooperate with each other in order to meet the challenges in the healthcare sector. Such cross-border initiatives could provide positive synergies between different systems and settings. 4. The European Commission should promote the more flexible and simplified use of Cohesion Policy Funds, both at national and regional levels, for investments in the healthcare sector including infrastructure (and including digital infrastructure) and services. The simplification measures should cover the reimbursement costs, access to funding for private entities, requirements for the project selection and implementation, and online procedures. 5. The European Commission should encourage and incentivise EU Member States to adopt new financing models including Managed Services, revolving instruments and models based on pay-as-a-service as part of the solutions for providing and maintaining high quality and sustainable healthcare services in support of social and territorial Europe, which is closer to citizens. 6. COCIR calls for the inclusion of a specific reference relating to investments in health and care infrastructure and services in the Cohesion Fund Regulation Proposal. 7. COCIR calls on the European Commission to promote innovation triangles with the mandatory participation of academia, technology companies and public authorities, to encourage and further support investments in innovation in the health sector.
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Response to Legislative proposals for ERDF/CF, ETC (Interreg) and ECBC

27 Jul 2018

COCIR welcomes the European Commission´s proposals for the next financial period 2021-2027, which put efforts towards simplifying and making the use of the EU Cohesion and Values Funds for the health sector more flexible. This contribution outlines key recommendations, which COCIR considers essential for the delivery of sustainable and high-quality health and care. These recommendations focus on the EC legislative proposals on the EU Cohesion and Values programmes (including the European Regional Development Fund -ERDF, Cohesion Fund -CF, and the European Social Fund Plus -ESF+), identified below and developed in the enclosed position paper. 1. The EU Cohesion and Values Funds should be made available to invest and encourage the scaling up of innovative healthcare and ICT technology solutions leading to better patients’ health and Europe’s healthcare system´s efficiency and economic recovery. 2. The European Commission should develop a robust framework of indicators relevant to access issues, which can be tailored to national and regional contexts. It is crucial for these indicators to measure access to medical technologies, which support diagnostic imaging, radiotherapy services, Digital Health, and Health ICT. 3. The European Commission should encourage and incentivise EU Member States to cooperate with each other in order to meet the challenges in the healthcare sector. Such cross-border initiatives could provide positive synergies between different systems and settings. 4. The European Commission should promote the more flexible and simplified use of Cohesion Policy Funds, both at national and regional levels, for investments in the healthcare sector including infrastructure (and including digital infrastructure) and services. The simplification measures should cover the reimbursement costs, access to funding for private entities, requirements for the project selection and implementation, and online procedures. 5. The European Commission should encourage and incentivise EU Member States to adopt new financing models including Managed Services, revolving instruments and models based on pay-as-a-service as part of the solutions for providing and maintaining high quality and sustainable healthcare services in support of social and territorial Europe, which is closer to citizens. 6. COCIR calls for the inclusion of a specific reference relating to investments in health and care infrastructure and services in the Cohesion Fund Regulation Proposal. 7. COCIR calls on the European Commission to promote innovation triangles with the mandatory participation of academia, technology companies and public authorities, to encourage and further support investments in innovation in the health sector.
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Response to Multiannual Financial Framework: Digital Europe programme

27 Jul 2018

COCIR has the following recommendations focusing on Health Care, which are further developped in the full document: 1. Based on the central role played by the digital industry in transforming Health & Care through integrated Care, more funding needs to support our industry to ensure Europe keeps a pole position on innovation. 2. To operationalise the existing European Interoperability Framework (IHE profiles and PCHA Guidelines) and its adoption and extension, it is critical to support the establishment of a European coordinated interoperability conformity assessment process as recommended by the EuroCAS project to ensure consistency among the national conformity assessment programmes in health 3. Member States should get support to ensure an appropriate IT infrastructure in their regions and country. 4. There is a need to increase awareness of what digital solutions can provide during Health Care curricula but also through continuous learning tools for Health Care practitioners, users and citizens.
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Response to MFF: 9th Framework Programme for Research and Innovation and Rules for Participation and Dissemination

27 Jul 2018

We welcome the European Commission proposal for Horizon Europe published on 7 June. Following on its predecessor Horizon 2020, Horizon Europe is supposed to be the most ambitious Research and Innovation programme of the European Union yet. As Commissioner Moedas said when announcing the new programme, Europe has built a “global reputation as a world leader in research and innovation programming”. As the most innovative sector in terms of patents in Europe, the medical technology and digital health industry highlights the need to support research, development and innovation at the European level. COCIR members have a long-standing engagement in EU-funded research and innovation and look forward to the development of the new programme. You find our detailed recommendations in the attachment.
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Meeting with Vytenis Andriukaitis (Commissioner) and

17 Jul 2018 · HTA, digital health and care, medical devices

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

13 Jul 2018 · HTA, medical devices

Meeting with Vytenis Andriukaitis (Commissioner) and

15 Jun 2018 · HTA

Response to EU cooperation on Health Technology Assessment

30 Mar 2018

COCIR welcomes the EC proposal on HTA cooperation in the European Union, adopted on 31 January 2018, in which the majority of the concerns highlighted in COCIR contribution to the European Commission public consultation on strengthening of the EU cooperation on HTA are considered. COCIR believes the current EC proposal is an important step towards more harmonized, sustainable and timely joint therapeutic value assessments, which should help bringing the innovation to patients much faster than today. COCIR concur joint clinical assessments have the potential lead to effective, innovative health tools reaching patients faster. However, for patients to be able to use innovative technologies, there are certain conditions to fulfill, which COCIR wishes to develop in the 5 following points: 1. COCIR believes it is important that multi-application technologies remain out of scope of the proposed legislation; since, clinical evaluations of procedures conducted using multi- application medical technologies are only relevant within the context of nationally defined healthcare practices and priorities, and the medical practices involving these technologies vary across the EU Member States. 2. Should an HTA cooperation be implemented in EU, COCIR recommends developing and use methods, data requirements and outcome measures that are appropriate for and tailored to the specificities of medical technologies. 3. COCIR believes the regulatory framework proposed by the European Commission has the potential to bring benefits to patients, especially those with unmet medical needs. Yet, to ensure patients have access to cutting edge, high-quality innovative medical technologies, HTA bodies should work through constructive and open dialogue with health technology developers, to generate data for joint assessments. Because of a great diversity among medical technologies, some technologies may generate evidence at a later stage. Therefore, the time flexibility to provide data for joint assessments is necessary, to avoid the situation where a medical technology is rejected, due to insufficient evidence. 4. the extent to which patients will benefit from accelerated uptake of innovative technologies will depend on national decision – makers. COCIR strongly encourage that any HTA is EU Member States demand-driven and relevant, processed with constructive involvement of health technology developers, which means HTA for medical technologies should not be performed as a systemic additional administrative hurdle. Instead, HTA should be instructed to answer a specific question raised by one or more Member States about a specific medical technology, and to inform specific decisions on reimbursement, clinical guidelines recognition, or procurement etc. 5. cost-effective innovation can eventually lead towards more effective and sustainable health delivery for Member States. To ensure the EU cooperation on HTA is financially sustainable, also beyond the 2020, COCIR believes it is necessary the EU continues funding joint cooperation on HTA in the EU. COCIR strongly encourage further synergy between the European Commission and the co-legislators, the European Parliament and the Council, through adoption of the Regulation. Please find enclosed COCIR Position Paper on the EC Proposal on HTA.
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Meeting with Vytenis Andriukaitis (Commissioner) and

8 Dec 2016 · Integrated care