New pilot to support development of ‘breakthrough’ medical devices
WHY IT MATTERS
This pilot could speed up access to innovative medical devices for rare disease patients in the EU by streamlining the regulatory review process, though specific diseases and devices in the program have not yet been announced.
The European Medicines Agency (EMA) has started a new pilot program to help companies develop breakthrough medical devices faster in Europe. This program tests new ways to review and approve devices that could help patients with serious conditions. The goal is to make it easier for innovative medical tools to reach patients who need them.
Source: European Medicines Agency (EMA) Description: EMA has launched a pilot programme to support the development of breakthrough medical devices in the European Union (EU). The purpose of the pilot is to test a new regulatory… Published: 2026-04-28T09:26:00.000Z Note: EMA announcements cover medicines approved in the EU. Orphan designations may not yet be available in the US.