EMA pilot programme for breakthrough medical devices and IVDs to launch Q2 2026; info session 24 April 2026

Published: 15 Apr 2026

EMA will launch a pilot in Q2 2026 giving designated breakthrough devices and IVDs enhanced regulatory support and priority scientific advice from its medical device expert panels. An online information session is scheduled for 24 April 2026, and the pilot builds on MDCG 2025-9 (Guidance on Breakthrough Devices, December 2025). The Commission's December 2025 MDR/IVDR revision proposal includes a future breakthrough framework (new MDR Article 52a and IVDR Article 48a). Manufacturers must request an opinion from EMA's expert panels to obtain designation; EMA will publish further guidance and templates before the pilot starts.

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

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