The EU regulatory framework for medical devices continues to evolve. While the core framework of the Medical Devices Regulation (MDR, Regulation (EU) 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746) has been in force since 2017, and recent developments reflect ongoing efforts to make the system more efficient and proportionate.
On 16 December 2025, the European Commission launched a formal process by publishing a proposal for targeted amendments to the MDR and IVDR. The aim is to develop the regulatory framework in a way that better serves both the industry and patients – without compromising on safety.
The full proposal and accompanying documents are available on the Commission’s website:
Why Are Changes Being Considered?
The Commission’s proposal is grounded in an extensive evaluation, public consultations, and feedback gathered from stakeholders. The current regulatory framework has proven overly burdensome in some areas, particularly for small and medium-sized enterprises. High compliance costs, complex administrative processes, and certification delays risk slowing down innovation and reducing the availability of devices for European patients. The proposal therefore seeks targeted simplifications without altering the core objectives of the regulations. Commission preparatory documents highlight the potential of the reforms to reduce the administrative burden on the sector and generate cost savings.
EU4MEDTECH’s own research also supports this direction. Literature reviews, surveys, and interviews conducted across the project’s work packages have revealed that many stakeholders – including industry representatives, member states, and notified bodies – face challenges related to compliance costs, administrative complexity, and certification delays. These findings further reinforce the case for developing the regulatory system.
Current Status of the Proposal
The proposal remains in draft form (COM(2025) 1023 final, procedure 2025/0404(COD)) and is progressing through the EU legislative process, where the European Parliament and the Council may introduce amendments. The process is at an early stage and the Commission is currently gathering feedback on the proposal. This is a concrete opportunity to influence the final content of the proposal. Feedback can be submitted via the EU’s official Have Your Say portal: Have Your Say – Medical devices and in vitro diagnostics: targeted revision of EU rules. Based on current information, the deadline for submitting feedback is 30 June 2026.
Taking the time to understand the proposal and its implications is well worthwhile, as it enables stakeholders to prepare for upcoming changes in good time. Across Europe, industry actors have already been actively sharing information and engaging in discussion on the proposal’s content. In Finland, for example, the topic was addressed at Healthtech Finland’s seminar day on 4 February 2026, where up-to-date information and industry perspectives were shared under the guidance of experts including Nelli Karhu and Erik Vollebregt. Further insights from an industry perspective are available in the article: Extensive Proposal to Amend Medical Device Regulations
Now is the right time to act: follow the discussion, participate in knowledge sharing, and contribute your input. The more actively stakeholders engage, the better the outcome can reflect the real needs of the field.
Impact on the EU4MEDTECH Project
The ongoing regulatory process has broad implications for all EU projects and organisations operating within the medical devices regulatory landscape. The evolving regulatory environment calls for a proactive approach and readiness to adapt. Practical challenges may arise from EUDAMED compatibility requirements, cybersecurity reporting obligations, and national differences in interpretation, which typically emerge in the early stages of regulatory change.
EU4MEDTECH is also following developments closely, as the shifting regulatory environment presents challenges for the project that require proactive management. The topic was discussed at the project’s consortium meeting in Finland on 24–25 February 2026. Risk management covers continuous monitoring of the regulatory and legislative environment, close tracking of MDR/IVDR standardisation activities, and flexible design of the digital platform to withstand future regulatory changes. EU4MEDTECH is also preparing its own comments on the proposal, to bring forward practical experiences and the project’s perspectives.
This proactive approach helps ensure that EU4MEDTECH remains a valuable resource in supporting compliance with MDR/IVDR requirements, even as the regulatory landscape continues to evolve. As the regulatory framework continues to evolve, active engagement and continuous learning are key to ensuring that change is embraced as an opportunity rather than a challenge.
