There have been a number of recent regulatory developments affecting medical devices and in vitro diagnostic devices in the EU, building on the European Commission’s proposal to simplify the medical devices regime published at the end of 2025, and in the UK. These developments include procedural requirements for notified bodies’ conformity assessment activities under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), political agreement on amendments to the EU Artificial Intelligence Act, and significant reforms to the UK medical devices regime.
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