The European Commission has proposed a package of measures to improve the health of EU citizens, while ensuring the long-term resilience and competitiveness of the health sector, which includes a Biotech Act, revised rules for medical devices, and a Safe Hearts Plan.

• 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.

• The Safe Hearts Plan presents targeted measures to improve prevention, detection and treatment of cardiovascular diseases, as 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 proposal for a regulation to simplify rules on medical and in vitro diagnostic devices will support the digitalisation of procedures, and offer a coherent framework so that companies can respond to changing market conditions and patient needs. 

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. The Commission will also begin work with Member States to start implementing the key deliverables of the “Safe Hearts” plan.