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Medtech & Pharma Platform Association

MPP

The Medtech & Pharma Platform Association (MPP) is a European cross-sectoral not-for-profit industry association focusing on combined products, i.e.

Lobbying Activity

Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics

6 Oct 2025

The Medtech & Pharma Platform Association (MPP) wishes to respectfully draw attention to a series of persistent challenges that continue to hinder the effective and proportionate functioning of the European Unions regulatory framework governing medical devices and in vitro diagnostics. Foremost among these concerns is the increasing complexity of regulatory requirements, which has led to heightened uncertainty and administrative burden for economic operators and other stakeholders. The financial implications of compliance, particularly for small and medium-sized enterprises (SMEs) and entities engaged in pioneering innovation, are substantial and risk undermining the competitiveness and diversity of the sector. Moreover, delays in market access have resulted in the deferred availability of medical technologies, with tangible consequences for patients and healthcare systems, as well as for industry actors striving to deliver timely and innovative solutions. In light of these developments, MPP respectfully submits a set of targeted recommendations aimed at enhancing regulatory efficiency and reinforcing stakeholder engagement. These include: Clarification of regulatory responsibilities, with a view to reducing ambiguity and avoiding duplication of efforts; Streamlining of regulatory procedures, to facilitate timely approvals and mitigate procedural bottlenecks; Strengthening of regulatory infrastructure and guidance, notably through increased support for notified bodies and the provision of clearer, more accessible documentation; Establishment of accelerated regulatory pathways for innovative and high-priority technologies, to ensure timely access to critical medical solutions; Promotion of inclusive and transparent multi-stakeholder dialogue, to ensure that policy development is informed by diverse perspectives and grounded in practical realities. In conclusion, MPP calls for a constructive and forward-looking reform of the MDR and IVDR frameworks. Such reform should seek to foster innovation within the European medical technology sector, improve patient access to safe and effective products, and enhance the overall efficiency and responsiveness of the Unions regulatory environment. These observations are substantiated by the enclosed survey results, reflecting the experiences and perspectives of MPP members regarding the implementation of the MDR and IVDR and the opportunities for improvement therein.
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Response to Biotech Act

11 Jun 2025

The Medtech & Pharma Platform Association (MPP) brings together companies from the pharmaceutical, MedTech, Diagnostics, and Tech sectors to advance combined products, i.e. solutions that integrate drugs, devices, diagnostics, and digital technologies for medical purposes. Among MPPs goals is the strengthening of cross-industry synergies, developing new collaboration models for faster market access to safe, innovative therapies, and advocating for balanced, proportionate regulatory frameworks for combined products. Key priorities the MPP recommends for the planned EU Biotech Act, especially for combined products, are: Ensure regulatory consistency and simplification: Align the Biotech Act with existing EU regulations (such as MDR, IVDR, and pharma legislation (incl ATMPs) as well as the AI Act, Data Act, Cybersecurity Act, GDPR and others) and make use of the opportunity to harmonize overlapping requirements for combined products to ensure continuation of patients access to medicines and devices. Reference is made to MPP publications on current bottlenecks in approval of new medicines, e.g. survey results wherein 45% of respondents encountered repetitive reviews and delays in the approval of marketing authorization applications for combined products that incorporate previously used/existing delivery technology (MPP-Letter-Planned-targeted-evaluation-of-MDR-IVDR_21-October-2024.pdf) as well as concerns highlighted by other industry associations with similar concerns (efpias-list-of-proposals-clinical-trials-15-apr-2025.pdf) Promote harmonization across Member States: Leverage the Biotech Act to drive harmonization and simplification of national requirements, particularly for clinical trials and clinical evidence generation, through improved alignment and cooperation between national competent authorities. Clarify definitions and regulatory pathways: Harmonize definitions and approval processes across the Biotech Act, MDR, IVDR, AI Act, ATMPs, Data Act, and GDPR to avoid delays due to inconsistent interpretations and regulatory fragmentation. Strengthen manufacturing and supply security: Link the Biotech Act to EU manufacturing and supply chain security frameworks such as the Critical Medicines Act and Regulation (EU) 2024/1860 to mitigate dependency on external markets and ensure reliable medicines and device access for EU patients Facilitate flexible and accelerated market access: Introduce streamlined, flexible regulatory pathways, e.g. lean clinical evidence requirements, fast-track options, and build on initiatives like COMBINE and SME support programs to enable the much needed translation Europes strong biotech research into competitive products.
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Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

20 Mar 2025

We would like to bring to your attention the letter submitted by the Medtech & Pharma Platform (MPP) to the Commission in October 2024, which outlines key considerations ahead of the targeted evaluation of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). The implementation of the MDR and IVDR has made substantial progress in the last few years and important measures were put in place to address some of the most pressing issues. The MPP Association would like to draw your attention to the following challenges currently faced by our members in relation to the MDR compliance: 1. Scientific advice: The above-mentioned survey highlighted that 25% of respondents faced hurdles in obtaining advice for their integral and non-integral combined products due to the absence of appropriate stakeholders, including NBs, device manufacturers, or competent authorities, in the scientific advice discussions, adversely affecting registration timelines. One possible solution to address this aspect is to consider adopting a more flexible interpretation of the rule disallowing Notified Bodies to provide consultancy services to allow them to participate in scientific advice procedures. 2. Conflicting advice: Through our survey, it was also found that greater alignment between the EMA, National Competent Authorities (NCAs) and NBs is needed when assessing aspects like the summary of product characteristics (SmPC) and the package leaflet (PL) of co-packaged combined products. 55% of respondents reported having received conflicting requirements/advice from the EMA/NCA and NBs; of those 55%, 35% could find a compromise to address the conflicting feedback, while 20% reported that no compromise could be found and that they followed requirements formulated by the NB. The MPP would welcome common guidance and shared training between the EMA and the NBs to build staff expertise and expert knowledge on the specific aspects and implications of combined products. This would contribute to the high quality and reliability of the scientific evaluation and thus foster a mutual understanding and interpretation of applicable rules and standards. 3. Lifecycle management: There remains a lack of clarity around the lifecycle management of products under MDR Art. 117, especially around substantial changes. The MPP would like to highlight the need for further clarity on substantial changes and notes that it would be beneficial for all relevant stakeholders to discuss and agree on the specific definition and examples of what constitutes substantial changes with the potential to impact on safety and performance. 4. Repackaging/relabeling of medical devices: MDR Art. 16 proves challenging for companies that repackage and/or relabel medical devices when co-packing the medical device with a medicinal product. Neither EMA guidelines nor MDCG 2021-26 address the specific situation of highly regulated pharmaceutical companies co-packaging a device, typically obtaining the CE marked medical device as bulk ware from the legal manufacturer (without individual labeling). The MPP Association would welcome clarification of which obligations apply to such companies, including through the update of MDCG 2021-26. 5. Post market requirements for co-packaged medical devices: There remains uncertainty for pharmaceutical companies with regard to which post market obligations apply to pharmaceutical companies when putting a co-packaged medical device on the market. The MPP would welcome greater clarity and predictability on the responsibility and liability of the pharmaceutical company and the medical device legal manufacturer for a co-packaged product. We thank you for considering our position and the proposals outlined above. The MPP Association is available for further dialogue and collaboration with the European Commission.
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Response to Evaluation and revision of the general pharmaceutical legislation

13 Oct 2023

The Medtech & Pharma Platform Association (MPP) welcomes the proposals objectives to improve the availability and accessibility of medicinal products throughout the EU and support industry competitiveness. We would like to propose amendments on points which are of importance for products combining medicines and medical devices including in-vitro diagnostics and therefore fall under the scope of both the medicinal product and medical devices legislation in the EU. The MPP advocates for a better alignment of the text of the proposals with the applicable medical devices legislation, i.e. Regulation 2017/745 (MDR) and Regulation 2017/746 (IVDR), on various aspects including definitions, in order to avoid divergences and legal uncertainties. Additionally, the MPP calls for clarifications on several points which are not sufficiently specified or may lead to conflicting interpretations. This includes the information supporting medical device/IVD compliance with the MDRs/IVDRs requirements which can be requested by the competent authorities as part of marketing authorization and variation applications or a pediatric investigation plan, the assessment of the risks linked to the medical device/IVD or the labelling and information requirements of combined products*. The MPP recommends incorporating measures in the legislation that would allow Notified Bodies to provide an opinion on medical device technology platforms which are part of drug device combinations covered by the EU medicinal product legislation. This will prevent work duplication in the review of the information relating to the platform, as the notified body opinion on the platform would be considered when assessing specific combinations. Furthermore, proposed amendments aim to ensure that Notified Body expertise is considered during the scientific advice procedure for medicinal products used with a medical device. Additionally, the role of medical device expert panels and the scope of their intervention should be clearly defined in the proposals. We recommend amending the proposals to clarify that products intended for the sterilization of packaging, specifically ethylene oxide, are covered by the medicinal product legislation, provided they are manufactured on a site holding a manufacturing authorization, in line with the position communicated by the European Commission in the first half of 2023. An overview of the MPPs specific feedback in relation to the proposed legislation is provided in the document submitted with this feedback. The MPP continuously seeks dialogue with relevant stakeholders to create an appropriate framework for combined products that fosters innovation, reduces time to market, and addresses patients needs. We thank you for considering our position and the proposals outlined in the attached document.
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Response to Evaluation and revision of the general pharmaceutical legislation

13 Oct 2023

The Medtech & Pharma Platform Association (MPP) welcomes the proposals objectives to improve the availability and accessibility of medicinal products throughout the EU and support industry competitiveness. We would like to propose amendments on points which are of importance for products combining medicines and medical devices including in-vitro diagnostics and therefore fall under the scope of both the medicinal product and medical devices legislation in the EU. The MPP advocates for a better alignment of the text of the proposals with the applicable medical devices legislation, i.e. Regulation 2017/745 (MDR) and Regulation 2017/746 (IVDR), on various aspects including definitions, in order to avoid divergences and legal uncertainties. Additionally, the MPP calls for clarifications on several points which are not sufficiently specified or may lead to conflicting interpretations. This includes the information supporting medical device/IVD compliance with the MDRs/IVDRs requirements which can be requested by the competent authorities as part of marketing authorization and variation applications or a pediatric investigation plan, the assessment of the risks linked to the medical device/IVD or the labelling and information requirements of combined products*. The MPP recommends incorporating measures in the legislation that would allow Notified Bodies to provide an opinion on medical device technology platforms which are part of drug device combinations covered by the EU medicinal product legislation. This will prevent work duplication in the review of the information relating to the platform, as the notified body opinion on the platform would be considered when assessing specific combinations. Furthermore, proposed amendments aim to ensure that Notified Body expertise is considered during the scientific advice procedure for medicinal products used with a medical device. Additionally, the role of medical device expert panels and the scope of their intervention should be clearly defined in the proposals. We recommend amending the proposals to clarify that products intended for the sterilization of packaging, specifically ethylene oxide, are covered by the medicinal product legislation, provided they are manufactured on a site holding a manufacturing authorization, in line with the position communicated by the European Commission in the first half of 2023. An overview of the MPPs specific feedback in relation to the proposed legislation is provided in the document submitted with this feedback. The MPP continuously seeks dialogue with relevant stakeholders to create an appropriate framework for combined products that fosters innovation, reduces time to market, and addresses patients needs. We thank you for considering our position and the proposals outlined in the attached document.
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Response to Extension of the transition period for medical devices

18 Jan 2023

The Medtech & Pharma Platform Association (MPP) is writing to you to share its views on the European Commissions proposal regarding the transition periods of the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). Overall, the MPP supports and welcomes the proposal, which is crucial to ensure the continued supply of products to patients. We also support the European Commission's proposal to delete the 'sell-off' date from the MDR and the IVDR. We would like to share the following points on selected amendments. In MDR Art. 120 (2), the second paragraph states that certificates are valid until the dates set out in paragraph 3b. In the explanations to the proposal, it is written that The extension is directly applicable, so that notified bodies are not required to change the date on the individual certificates. This solution is understandable as it is minimizing the burden for Notified Bodies. It is however hard to explain to third countries why a certificate with an expired valid until date is still valid under MDR and is still acceptable. We invite the European Commission to publish an official statement that can be used as an explanation to third-country national authorities. The further division of MDR Art. 120 (3) in subparagraphs is welcomed. But the article is still very complex to read as requirements are spread over several paragraphs and subparagraphs and it can create confusion: in MDR Art. 120(2), the second paragraph states that such certificates are valid until the dates set out in (3b) (without mentioning any conditions at all); MDR Art. 120 (3a) then refers to conditions in (3d) for the application of the dates of (3b) for the placing on the market. It could thus be read as certificates are generally valid until 2027/2028 but their placing on the market is only allowed if the conditions in (3d) are fulfilled. Having a valid certificate without being allowed to place a product on the market does not make sense. We propose to revise Art. 120 in an order that prevents possible divergent interpretations. Art. 120 also is lacking clear provisions for devices with a valid certificate according to MDR Art. 120(2), but not fulfilling the conditions of MDR Art. 120 (3d), i.e. when no transfer under the MDR is planned. A possible solution would be to allow such devices to be placed on the market until the expiry of their current MDD/AIMDD certificate, but without the extended transition periods. It would be ideal if a harmonized approach for such cases could be clearly stated. In MDR Art. 120 (3d), the addition of further conditions is understandable. However, the conditions require more detailed descriptions / definitions. Otherwise, they run the risk of opening new questions. We propose to clarify the conditions in MDR 120 (3d). As previously stated, the European Commission proposal is much welcomed. However, further challenges of the MDR exist that require solutions; we therefore encourage all stakeholders to implement solutions laid out in MDCG 2022-14. MPP continuously seeks dialogue with relevant stakeholders to create an appropriate framework for combined products that fosters innovation, reduces time to market, and addresses patients needs. We thank you for considering our position and the proposals outlined above. The MPP remains at the European Commissions disposal for further dialogue and collaboration.
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Response to Requirements for Artificial Intelligence

30 Jun 2021

The not-for-profit MPP Association welcomes the European Commission proposal for a Regulation laying down rules on AI. MPP supports efforts to optimize the regulatory framework to create the right conditions for healthcare innovation. We are the opinion that risk categories for AI provide a useful base for the regulation of AI. In this area, we would welcome clarifications on the determination of the high-risk category in the proposed Regulation and how such category correlates to existing legal frameworks, especially with the Medical Devices and In Vitro Diagnostics Regulations (MDR & IVDR). Notably, there is a concern that the existence of different risk assessments under the AI and medical device legislations might create confusion. Under a risk-based regulatory system and in consideration of the scope of use, some AI-driven software may be categorized as low or intermediate risk under the MDR and IVDR, whereas the proposed Regulation may classify such products as high-risk. In this regard, it could be beneficial to consider aligning the risk levels described in the proposed Regulation with risk levels outlined in the MDR and IVDR for consistency. The recently entered into force MDR and upcoming IVDR provide an adequate framework for the regulation of Medical Device Software (MDSW) and it is important to make sure that the proposed Regulation is fully compatible with them. In addition, MPP would like to share the following comments and questions: •Recital 60: Does this imply that a pre-trained model cannot be used in an AI high-risk system as a software of unknown (or uncertain) pedigree (or provenance) (SOUP) or off-the-shelf (OTS), for which the collaboration of the supplier is not necessarily needed? •Article 43 section 4: How does the process for pre-determined changes for MDSW work? Are the rules mentioned in this article supposed to come from the regulators or does the paragraph mean that the manufacturer can specify in the instructions the modification (e.g. in accuracy) that can occur without implying a "substantial modification"? •Annex II: Companies may develop internal products in the areas of high-risk AI systems. How does the EU intend to monitor the internal usage of AI systems that do not reach the market? •Annex IV: Is the pre-specification in this Annex comparable to (SPS) Software as Medical Device (SaMD) pre-Specifications, Algorithm Change Protocol (ACP) from the US Food and Drug Administration (FDA) AI Discussion Paper on the regulatory framework for modification to AI /machine learning (AI/ML) based SaMD? Is there any possibility to harmonize those two approaches with the current proposed Regulation? •Annex IV, 2(e): More clarification is needed on how human oversight is defined and applicable, examples from medical device software would be appreciated. •The proposal states that it will consider harmonized technical requirements. Will standards such as IEC 62304, ISO13485, ISO14971 be integrated? •How does the Commission plan to build the regulatory sandboxes to facilitate products following regulations MDR and IVDR? More specifically, can certain activities, like data collection with the purpose of building a model or tests for clinical evaluation, be performed in the context of these sandboxes? And what would be the regulatory steps to move from a sandbox to the market for such a product? •How is the expansion of the AI system (e.g. scaling up to different devices, from Android to iDevice) organized in terms of submission? The proposed penalties in case of infringement may impact the commitment of manufacturers in ensuring deep and intensive monitoring of their own AI systems in the post-market surveillance phase. To promote a shared culture of rigorous monitoring, incentives to the manufacturers that find incidents in their own AI system could be put in place. Such incentives could, for instance, materialize via decreased fines when infringements are found and address by manufacturers themselves.
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Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

To whom it may concern, The Medtech & Pharma Platform Association (MPP) is writing to you to share its views on the European Commission’s combined roadmap/inception impact assessment on the evaluation and revision of the general pharmaceutical legislation. MPP is fully supportive of the points laid out in the evaluation roadmap. Firstly, ensuring the coherence and complementarity with other legislations, including those on combination products and medical devices, and providing for the continuous and timely adaptation of technical requirements is extremely important. The interface between EU legal frameworks is key for combined products (please see the attached document for more details on the corresponding definitions) as they constitute an increasingly significant part of innovation. It is important that all actors from the pharma and medical devices sectors, including the European Commission, the European Medicines Agency, National Competent Authorities, Notified Bodies and industry actors cooperate to find pragmatic solutions to establish a proportionate regulatory framework. For new technologies incorporating digital aspects such as connected combined products, the challenges are even greater as the application of important horizontal frameworks such as Data Protection, Artificial Intelligence (AI) and Cybersecurity in addition to frameworks for pharmaceutical products and medical devices (and their combined use) is to be considered. Separately, when it comes to personalized medicine, the opportunities to benefit the individual patient must be fully realized with a more holistic approach to the patient’s overall health and well-being. Secondly, MPP also supports the introduction of elements of flexibility that allow future proofing of the pharmaceutical legislation through adaptability to the new innovative ways in which medicines are developed and evidence is generated, taking into account new possibilities in areas such as digital and personalized medicine and the interplay of medicines and medical devices. In this area, MPP is of the opinion that the assessment ought to consider a way to favor digitalization in order to achieve a smoother integration with the pharma and medical devices legislations, provided that compliance with EU General Data Protection Regulation is ensured. For instance, it is important for the pharmaceutical framework to provide a solid basis for the development of guidelines that support the transition from clinical development using software applications or AI in drug development to the evaluation of a marketing authorization application by responsible stakeholders and, more importantly, that support the commercialization of medicinal products where AI continues to be used in a clinical setting. Thirdly, MPP commends the European Commission’s intention to make the pharmaceutical legislation more responsive and adapted to innovation and to render its regulatory procedures more efficient, considering existing constraints on European innovators and small and medium size enterprises in particular. As highlighted in the roadmap, it is especially important for complex innovative (connected) combined products, which are at the intersection of several legislations. Two aspects are especially vital, creating an appealing environment for innovation and leveraging aspects of the medical device regulatory framework for complementary digital health solutions for pharmaceutical products to enhance the patient experience in areas such as the monitoring of disease symptoms or medication compliance. MPP continuously seeks dialogue with relevant stakeholders to create an appropriate framework for combined products that fosters innovation, reduces time to market, and addresses patients’ needs. We thank you for considering our position and the proposals outlined above. The MPP remains at the European Commission’s disposal for further dialogue and collaboration.
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Meeting with Vytenis Andriukaitis (Commissioner) and

15 Jun 2018 · HTA