Proposal for simplifying rules for MDR/IVDR
Summary of the Proposal (read here)
Objective
The proposal from December 16, 2025, aims to simplify and reduce the regulatory and administrative burden associated with the EU MDR (2017/745) and the EU IVDR (2017/746), while preserving a high level of patient safety and public health protection. It also introduces targeted amendments.
Key Elements of the Proposal
1. Simplification and Burden Reduction under MDR and IVDR
- Administrative streamlining for manufacturers, notified bodies, and other economic operators, particularly SMEs.
- Reduction of unnecessary or duplicative regulatory requirements that do not provide proportionate safety or performance benefits.
- Improved practical workability of existing obligations without reopening the core safety architecture of the MDR/IVDR.
- Continued focus on addressing capacity constraints within the conformity assessment system.
- Reduction of unnecessary or duplicative regulatory requirements that do not provide proportionate safety or performance benefits.
- Improved practical workability of existing obligations without reopening the core safety architecture of the MDR/IVDR.
- Continued focus on addressing capacity constraints within the conformity assessment system.
2. Support Role of the European Medicines Agency (EMA)
- Amendment of Regulation (EU) 2022/123 to formally strengthen and clarify the EMA’s role in:
- Providing scientific and administrative support to expert panels on medical devices.
- Enhancing the coordination, consistency, and efficiency of expert panel activities.
Objective: improve the quality and timeliness of expert advice, particularly for high-risk and innovative devices.
- Providing scientific and administrative support to expert panels on medical devices.
- Enhancing the coordination, consistency, and efficiency of expert panel activities.
Objective: improve the quality and timeliness of expert advice, particularly for high-risk and innovative devices.
3. Alignment with EU Artificial Intelligence Act
- Amendment of Regulation (EU) 2024/1689 (AI Act):
- Updates Annex I to explicitly include the MDR and IVDR as Union harmonization legislation.
- Purpose:
- Ensure legal coherence between medical device legislation and horizontal AI requirements.
- Clarify that AI-based medical devices fall within the combined regulatory framework, thereby avoiding legal ambiguity.
- Updates Annex I to explicitly include the MDR and IVDR as Union harmonization legislation.
- Purpose:
- Ensure legal coherence between medical device legislation and horizontal AI requirements.
- Clarify that AI-based medical devices fall within the combined regulatory framework, thereby avoiding legal ambiguity.
Overall Impact and Intent
- The proposal does not fundamentally alter the safety or performance requirements under the MDR/IVDR.
- It is primarily technical and procedural, focused on:
- Regulatory efficiency
- System sustainability
- Legal clarity across EU frameworks
- Aims to improve the predictability, proportionality, and feasibility of compliance for economic operators while maintaining patient safety.
- It is primarily technical and procedural, focused on:
- Regulatory efficiency
- System sustainability
- Legal clarity across EU frameworks
- Aims to improve the predictability, proportionality, and feasibility of compliance for economic operators while maintaining patient safety.
Practical Takeaway for Stakeholders
- Expect incremental simplifications, not deregulation.
- Manufacturers and notified bodies should monitor:
- Potential adjustments to documentation and procedural expectations.
- Improved interaction with EMA expert panels.
- Clearer interfaces between MDR/IVDR and AI Act compliance for AI-enabled devices.
- Manufacturers and notified bodies should monitor:
- Potential adjustments to documentation and procedural expectations.
- Improved interaction with EMA expert panels.
- Clearer interfaces between MDR/IVDR and AI Act compliance for AI-enabled devices.