The European Commission has published two delegated acts in the Official Journal of the European Union (OJEU) introducing additional well-established technologies (WET) under the Medical Devices Regulation (MDR).
Well-established technologies are generally considered to be relatively simple medical devices with stable and widely accepted designs, well-documented safety and clinical performance, and a long history of safe use on the European market. The newly published delegated acts expand the list of devices classified as WET under the MDR.
The aim of these changes is to make certain regulatory requirements more proportionate for manufacturers of these devices, thereby reducing unnecessary administrative burden while maintaining a high level of patient safety. This initiative forms part of the European Commission’s broader regulatory simplification agenda.
The updated list of WET devices was developed in 2025 by a dedicated Task Force of national experts within the Medical Device Coordination Group (MDCG), following a public call for evidence that enabled stakeholders to contribute to the process.
The delegated acts will enter into force 20 days after their publication in the Official Journal of the European Union. Manufacturers of affected devices should review the updated provisions to determine whether they may benefit from the revised regulatory requirements.
The delegated acts can be accessed using the following links:
