17/04/2026 (Agence Europe) – In the second quarter of 2026, the European Medicines Agency (EMA) will launch a pilot programme to support breakthrough medical devices and in vitro diagnostics, announced the European Commission on Wednesday 15 April. This scheme aims to accelerate patient access to highly innovative technologies, while maintaining the EU’s high standards of safety and performance. The manufacturers selected will benefit from enhanced regulatory support and priority scientific advice from the EMA’s expert panels. Ahead of this, an online information session will be held on 24 April to present the framework of the programme and its practicalities. The project is based on the MDCG 2025-9 guidelines recently adopted by the Medical Device Coordination Group. It will help shape a future European framework for breakthrough devices, which will be included in the European Commission’s proposal to revise the regulations on medical devices (see EUROPE 13848/11). (LC)