European Commission proposes a Regulation to simplify rules on medical and in vitro diagnostic devices

European Commission proposes a Regulation to simplify rules on medical and in vitro diagnostic devices

The European Commission proposed on 16 December 2025 a package of measures aiming to improve the health of EU citizens, while ensuring the long-term resilience and competitiveness of the health sector.

The package includes a Biotech Act, revised rules for medical devices, and a Safe Hearts Plan, which will:

• strengthen the EU biotechnology sector;
• accelerate the development of innovative new treatments and therapies for patients;
• make rules for the development of medical devices from lab to market simpler and more efficient for EU companies, while ensuring a very high level of patient safety; 
• tackle Europe’s leading cause of death, cardiovascular diseases, with a comprehensive EU approach to prevent, detect, and treat them in time.

The proposals aim to simplify EU rules for medical devices, support the digitalisation of procedures, and offer a coherent framework so that companies can respond to changing market conditions and patient needs.

• To speed up access to medical devices and guarantee a continuous supply, timelines to complete conformity assessments will be introduced.
• A stronger role for the European Medicines Agency (EMA) will strengthen coordination at EU level while companies will be offered more scientific, technical and regulatory expertise. The EMA will also monitor shortages of medical devices, and a list of critical devices will be created.
• Finally, the proposal will ensure uniform and coherent rules for medical devices incorporating AI applications.

Press release on new measures to make the EU health sector more innovative, competitive and resilient available here.

Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices available here.

Questions and answers on simpler and more effective rules for medical devices available here.