The EMA launches a pilot inspired by the American model to accelerate access to innovative technologies. A long-overdue catch-up or a risky bet?

Published in the Official Journal of the EU on 5 May 2026, this regulation sets for the first time uniform quality management and procedural requirements applicable to notified bodies under the MDR and IVDR, improving the market access timeline for medical devices. Adopted on 4 May 2026 by the European Commission, Implementing Regulation (EU) 2026/977…