Pilot programme to be launched to support breakthrough medical devices and in vitro diagnostics

In the second quarter of 2026, the European Medicines Agency will launch a pilot programme to support breakthrough medical devices and in vitro diagnostics. The aim is to test a pathway that accelerates patient access to highly innovative technologies, always maintaining the EU’s high standards for safety and performance. Through the pilot, manufacturers of designated breakthrough devices will be able to benefit from enhanced regulatory support and priority scientific advice from the medical device expert panels administered by European Medicines Agency.

Ahead of the launch of the pilot in Q2 2026, the European Medicines Agency will hold a an online information session on 24 April 2026. This information session will present the main elements of the Breakthrough Devices framework outlined and highlight practical considerations for stakeholders preparing to engage with the process.

The pilot builds on the recently adopted Guidance on Breakthrough Devices MDCG 2025-9 by the Medical Device Coordination Group (MDCG). The pilot will be a crucial element to shape a future possible framework for breakthrough medical devices, which the Commission has included in its proposal of December 2025 revising the Medical Devices Regulation and In Vitro Devices Regulation (new Article 52a of the MDR and new Article 48a of IVDR).

This initiative marks an important step in strengthening Europe’s innovation-friendly regulatory environment for medical technologies. To obtain breakthrough designation, manufacturers will need to request an opinion from EMA’s expert panels, with further guidance and templates for applicants to be published by EMA ahead of the pilot’s launch. The pilot also supports the Commission’s wider objective of promoting innovation in areas of major public health interest and ensuring continued confidence in the quality, safety and performance of advanced medical devices placed on the EU market.