European Commission Feedback Opportunity on a Proposal for the Targeted Revision of the EU Medical Device and IVD Rules
On 16 December 2025, the European Commission adopted and published a proposal for a Regulation amending Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) with the aim of simplifying the regulatory framework and reducing unnecessary burden.
The proposal would also amend Regulation (EU) 2022/123 in relation to the European Medicines Agency’s support for medical device expert panels and Regulation (EU) 2024/1689 (Artificial Intelligence Act (AI Act)), in relation to the list of Union harmonization legislation in its Annex I.
The proposal is currently open for feedback following its adoption by the Commission. The feedback received will be summarized and presented to the European Parliament and the Council to inform the legislative debate.
Overview
Authority | European Commission |
Date | 16 December 2025 |
Focus | Targeted revision of EU rules for medical devices and in vitro diagnostic medical devices |
Type | Feedback on a Commission proposal following its adoption |
Deadline for comments | 3 August 2026 |
What is this about?
The initiative concerns a targeted revision of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
This is not an early-stage public consultation. It is a feedback opportunity on a legislative proposal that has already been adopted by the European Commission and submitted to the European Parliament and the Council under the ordinary legislative procedure.
The proposal aims to simplify and streamline the applicable rules, reduce unnecessary administrative burden, and improve the predictability and cost-efficiency of conformity assessment and certification procedures. At the same time, it is intended to preserve a high level of public health protection and patient safety and to support the smooth functioning of the internal market.
The initiative responds to structural implementation challenges identified since the MDR and IVDR became applicable. These include regulatory complexity, high and sometimes disproportionate compliance costs, limited predictability of conformity assessment timelines, divergent practices across the EU, and concerns about device availability, innovation, and the competitiveness of the European medical technology sector.
Feedback details
The current opportunity relates to feedback on the Commission proposal following its adoption on 16 December 2025. The Commission states that feedback received will be summarized and presented to the European Parliament and the Council with the aim of feeding into the legislative debate.
The proposal addresses several areas, including:
Simplification of regulatory requirements and reduction of administrative burden for medical devices and IVDs
Improved predictability, efficiency, and consistency of conformity assessment procedures
Enhanced coordination and harmonization across Member States and notified bodies
Continued protection of patient safety and public health
Strengthened governance and coordination mechanisms within the EU regulatory framework
Expanded support for medical device expert panels through the European Medicines Agency
Better support for innovation, including niche and specialized medical technologies
Alignment with other Union legislation, including the AI Act and related EU regulatory frameworks
Key timeline
Commission adoption and publication of the proposal: 16 December 2025
Deadline for feedback: 3 August 2026, midnight Brussels time
Why this matters
This initiative is relevant for organizations affected by the MDR and IVDR because it represents one of the most significant proposed revisions of the MDR and IVDR framework since the Regulations became applicable.
For industry stakeholders, the initiative may affect regulatory planning, conformity assessment strategy, notified body interactions, clinical and performance evidence planning, post-market obligations, and product availability considerations.
As the proposal is now progressing through the EU legislative process, stakeholder feedback may help inform the legislative debate by highlighting practical implementation issues, proportionality concerns, and potential effects on innovation, small and medium-sized enterprises (SMEs), notified bodies, healthcare systems, and patient access.
Who should consider responding?
Medical device manufacturers
In vitro diagnostic medical device manufacturers
Notified bodies
Regulatory affairs and quality teams responsible for MDR or IVDR compliance
SMEs active in the medical technology sector
Industry associations and trade organizations
Healthcare and laboratory stakeholders affected by device availability or regulatory timelines
Patient organizations
Research institutions and innovation-focused medical technology developers
Practical implications
Stakeholders should consider:
Reviewing how the proposed amendments may affect MDR or IVDR compliance strategies
Assessing potential implications for conformity assessment planning and notified body interactions
Evaluating whether the proposal addresses current implementation challenges experienced by the organization
Preparing evidence-based feedback on simplification, proportionality, predictability, and patient safety considerations
Monitoring the legislative process after the current feedback period
Support with stakeholder responses
We support organizations in:
Assessing the relevance of regulatory feedback opportunities and consultations
Identifying strategic risks and opportunities
Preparing structured and evidence-based responses to authorities
Contact us if you would like to discuss how this proposal may affect your organization or planned regulatory activities.
Note
This feedback opportunity relates to a legislative proposal already adopted by the European Commission but not yet enacted. The proposal is currently under consideration by the European Parliament and the Council under the ordinary legislative procedure.
Stakeholders wishing to contribute to the debate on future MDR and IVDR requirements should consider participating before the feedback period closes.