The European Commission has proposed targeted amendments to the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The proposal, published on 16 December 2025, aims to streamline EU medical device and in vitro diagnostics (IVDs) rules to reduce unnecessary complexity and costs for manufacturers and notified bodies without lowering safety requirements. It responds to industry, Member States and Parliament requests for a more predictable and efficient framework.
The European Commission has opened an eight‑week feedback period until 18 March 2026 - find out more here.
Why is the Commission proposing changes now?
On 23 October 2024, the European Parliament called for a targeted revision of the MDR and IVDR after widespread feedback highlighted significant implementation challenges, such as disproportionate costs, high administrative burden and overall regulatory complexity. These issues, raised by stakeholders such as small and medium-sized manufacturers and healthcare providers, were seen as potentially limiting patient access to essential and innovative medical devices. In response, the European Commission initiated a public consultation in Dec 2024, followed by a call for evidence in October 2025. The resulting evaluation indicated growing concerns around reduced device availability, weakened competitiveness of EU-based manufacturers, particularly SMEs, and slower innovation, with some products being postponed or withdrawn from the EU market.
Our experience with MDR and IVDR implementation has shown that, while safety standards have improved, some requirements are complex, costly, and difficult to apply in practice. Certification delays, capacity constraints at notified bodies, and administrative burden, particularly for small and medium-sized enterprises, prompted the Commission to introduce targeted improvements.
Does this proposal lower safety or performance requirements for medical devices?
No. The proposal does not reduce core safety, clinical evidence or post-market surveillance requirements. Patient safety and public health protection remain the primary objectives of the EU medical devices framework.
What are the main objectives of the amendments?
The proposal aims to:
- Simplify and clarify regulatory requirements: Introducing a more proportionate framework, including updated classification rules (e.g., New Rule 11 for software in Annex VIII of the MDR), more flexible clinical evidence requirements, and revised PRRC obligations.
- Reduce unnecessary administrative complexity: Eliminating fixed certificate validity periods, reducing the frequency of PSUR updates, and allowing digital EU Declarations of Conformity and eIFUs.
- Improve predictability of conformity assessment procedures: Clearer rules on changes after certification, structured dialogue between manufacturers and notified bodies, and enhanced coordination on borderline and classification decisions.
- Support innovation and competitiveness: Introducing priority review for breakthrough and orphan devices, more flexible rules for in-house devices, and options for combined studies involving medical devices and medicinal products.
- Improve alignment with other EU legislation, including digital and AI rules: Ensuring that AI-enabled medical devices are primarily regulated under the MDR/IVDR, avoiding duplication with the EU AI Act where most high-risk AI requirements would not apply.
- Strengthen governance and oversight: Expanding the role of expert panels, codifying dispute resolution mechanisms, and promoting consistent decision-making across Member States.
How does this proposal affect manufacturers?
Manufacturers may benefit from:
- More proportionate and clearer regulatory requirements: Including lower classification for certain devices, more flexible clinical evidence acceptance (non-clinical data, equivalent device data), and simplified PRRC obligations.
- Reduced duplication in documentation and conformity assessment: Certificates no longer have a fixed five-year validity, PSUR update timelines are extended, and SSCPs/SSPs are required only for full technical documentation assessment.
- Improved regulatory predictability and planning: Clearer guidance on post-certification changes, structured pre- and post-submission dialogue with notified bodies, and defined timelines for borderline or classification decisions.
- Support for innovation and market access: Priority review for breakthrough/orphan devices, more flexible rules for in-house devices, fee reductions for micro and small enterprises, and early scientific advice from expert panels.
Does the proposal affect notified bodies?
Yes. The proposal seeks to:
- Clarify roles and responsibilities: Notified bodies’ duties are better defined, including structured dialogues with manufacturers and codified procedures for classification disputes.
- Improve efficiency and consistency in conformity assessments: Risk-based periodic reviews replace fixed certificate recertifications, remote audits are encouraged, and surveillance audits are less frequent where justified.
- Reduce bottlenecks in certification processes: Streamlined procedures, including early advice from expert panels, reduced administrative validation for SSCPs/SSPs, and coordinated assessments for combined studies, are expected to shorten review timelines and increase predictability.
How does this proposal interact with the EU AI Act?
The proposal clarifies how AI-enabled medical devices are regulated. It aims to avoid overlapping or duplicative conformity assessments by ensuring that AI used in medical devices is primarily assessed under the MDR or IVDR, where appropriate, rather than through parallel regulatory pathways. As a result, many of the requirements set out for high-risk AI systems under the EU AI Act would not apply to medical device manufacturers.
We previously explored the (EU) 2024/1689 (AI Act) here.
Is the European Medicines Agency (EMA) involved?
Yes. The proposal strengthens and clarifies the role of the EMA in supporting expert panels and coordination activities related to high-risk medical devices and IVDs.
Will existing certified devices be affected?
The proposal focuses on regulatory simplification rather than re-certification. Existing transition provisions and validity of certificates remain governed by MDR and IVDR rules unless explicitly amended in future implementing measures.
What stage is this proposal at?
This is a legislative proposal by the European Commission. It must be reviewed and adopted by the European Parliament and the Council, under the ordinary legislative procedure, before becoming EU law. Changes may occur during the legislative process.
Have your say on the proposal
The European Commission has opened an eight‑week feedback period, running until 18 March 2026, during which any interested parties are able to submit their feedback on the proposal. All feedback received will be shared with the European Parliament and the Council and considered as part of the legislative process.
What does this mean for patients and healthcare systems?
Patients and healthcare systems are expected to benefit from:
- Continued high safety and performance standards
- Improved availability of medical devices and diagnostics
- Faster access to innovative and digital medical technologies
Need help navigating the requirements of the EU MDR or IVDR? Contact us today to explore our services designed to help build your regulatory strategy with confidence.
