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CLNR

The European Commission has published two delegated acts under the Medical Devices Regulation (MDR) expanding the list of well-established technologies (WET). These are simple, long-established medical devices with stable designs and well-known safety and clinical performance. The updated rules reduce regulatory requirements for eligible devices, easing the burden on manufacturers as part of the Commission’s simplification agenda. The WET list was developed in 2025 by the Medical Device Coordination Group (MDCG) with input from stakeholders through a public call for evidence. The delegated regulations will enter into force in 20 days time.