The EU Commission continues efforts to cut red tape in the single market with a package of measures which it says will improve Europeans’ health while ensuring long-term resilience and competitiveness in 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.
“When innovation happens in Europe new treatments reach European patients faster and at an affordable cost, which is essential for robust world-class care,” said the EU Health Commissioner Olivér Várhely: “This is why today we are unlocking a new era of growth in the health sector with the Biotech Act, making Europe a global hub for health biotechnology. We are making it easier and faster to get life-saving medical devices to patients, and tackling Europe’s biggest killer – cardiovascular disease – with our ambitious Safe Hearts Plan.”
The Commission says the proposed Biotech Act will incentivise companies to conduct research and production within Europe, accelerate clinical trials authorisations across countries, and fast-track the development of cutting-edge new therapies using AI, data and regulatory sandboxes. It will also simplify EU regulations to reduce costs and burdens for companies. For complex innovative products it will establish single regulatory pathways.
Cardiovascular diseases kill 1.7 million Europeans every year, and cost the European economy €282 billion annually, says the Commission. The Safe Hearts Plan will help individuals with personalised disease prediction tools and therapies, while addressing risk factors like tobacco, unhealthy diets, and alcohol. It seeks to bridge research gaps and integrate data, digital solutions and artificial intelligence to strengthen health systems. With levels of early cardiovascular deaths varying significantly across EU countries, the Plan emphasises reducing health inequalities and improving access to healthcare and therapies. For example, the Commission will support Member States in developing national cardiovascular health plans, establish dashboards monitoring health inequalities, and launch an Incubator to speed up the use of AI.
The medical devices sector employs close to one million people, mostly in small and medium-sized enterprises, and the EU market is worth around €170 billion. The new 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. Finally, the proposal will ensure uniform and coherent rules for medical devices incorporating AI applications. Altogether, the measures should lead to overall cost savings of €3.3 billion per year, says the Commission, including €2.4 billion annual administrative savings.
Communication on an EU cardiovascular health plan: the Safe Hearts Plan
Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices
Questions and answers: Biotech Act
