New measures to make EU health sector more innovative, competitive and resilient

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.

Together, these initiatives will contribute to a more modern, efficient, and resilient health ecosystem for all EU citizens, while incentivising growth and innovation in this strategic sector.

Medical Devices

The EU is a world leader in medical devices. The sector employs close to one million people, mostly in small and medium-sized enterprises, and the EU market is worth around €170 billion. However, current EU rules are creating unnecessary costs, bottlenecks, uncertainty for companies, and delays for patients.

Today's proposals will 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. The reform will ensure that patient safety remains the highest priority, while enabling faster access to safe and innovative devices and strengthening the EU's competitiveness in this vital sector. Finally, the proposal will ensure uniform and coherent rules for medical devices incorporating AI applications. Altogether, these measures should lead to overall cost savings of €3.3 billion per year, including €2.4 billion annual administrative savings.

Next Steps

The legislative proposals for a Biotech Act and simplification of the Medical Devices and In vitro Diagnostics Regulations will now be submitted to the European Parliament and the Council for adoption. We will also begin work with Member States to start implementing the key deliverables of the “Safe Hearts” plan.

Source: European Commission, press release of 16 December 2025
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Excerpts from the original text reproduced; text abridged by the editors.

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