New EU pilot programme for breakthrough medical devices and in vitro diagnostics

The European Medicines Agency (“EMA”) is set to launch a pilot programme providing expert panel advice for developers of breakthrough medical devices and in vitro diagnostic medical devices (“IVDs”) in the second quarter of 2026. This pilot programme is intended to build on the guidance on breakthrough medical devices and IVDs (hereafter, “breakthrough technologies”) issued by the Medical Device Coordination Group (“MDCG”) last December (see here: MDCG 2025-9).... By: Hogan Lovells