EMA launches pilot program for ‘breakthrough’ medical devices in EU

The European Medicines Agency on Tuesday launched a pilot program for “breakthrough” medical devices in the European Union, opening a new support route for selected manufacturers of highly innovative products. Companies whose devices receive breakthrough status in the pilot will get enhanced regulatory support, including priority scientific advice from EU medical-device expert panels overseen by EMA.

The move matters because it gives Brussels a chance to test a more structured pathway for novel devices before broader legal changes are finalized. EMA said the aim is to “support patient access to highly innovative technologies, while maintaining the EU’s rigorous safety and performance standards.” The pilot does not replace the EU’s existing medical-device laws, the Medical Device Regulation and In Vitro Diagnostic Regulation. Instead, it is being tested within the current system as policymakers consider a formal breakthrough-device framework.

Phase one is limited to the EU’s highest-risk devices: Class III medical devices and Class IIb active medical devices intended to administer or remove medicines from the body. EMA said the pilot will run in three phases and is scheduled to continue through 2027, subject to available resources. Later phases are expected to expand the approach to other device categories, including in vitro diagnostics, or IVDs, which are tests used on samples such as blood or tissue.

Manufacturers seeking breakthrough designation must submit a request for an opinion to the medical-device expert panels. EMA said the panels will assess applications based on factors including the degree of innovation and whether a device could address an unmet medical need or provide a significant clinical benefit. The agency has published phase-one guidance and application templates, and it held an information session on the pilot on April 24.

EMA launched the pilot in close collaboration with the European Commission, the EU’s executive arm. The agency said the initiative builds on guidance published in December 2025 by the Medical Device Coordination Group, an EU body that helps coordinate implementation of device rules across member states. That guidance defined breakthrough devices as highly novel products expected to deliver significant clinical benefit or meet unmet medical needs, particularly for serious conditions.

The pilot also arrives as the European Commission pursues a December 2025 proposal to revise the EU’s medical-device and diagnostics laws to create formal breakthrough-device provisions. That proposal has not yet become law. For now, the MDR and IVDR remain the core legal framework for devices in the bloc, and the new program is a support mechanism rather than a new approval system.

EMA described the launch as “a first step toward formal implementation” of a breakthrough-device framework in the EU. In a news announcement published Tuesday, the agency said, “EMA has launched a pilot programme to support the development of breakthrough medical devices in the European Union (EU).” It also said there are currently no fees associated with similar expert-panel advice procedures, a point that may help lower the barrier for companies seeking early scientific feedback under the pilot.