Two delegated acts on well-established technologies (WET) under the Medical Devices Regulation have been published today in the Official Journal of the EU.
Well-established technologies are relatively simple devices, with common and stable designs that don’t evolve much, well-known safety and clinical performance characteristics, and a long history on the market. The delegated regulations published today expand the list of WET devices under the Medical Devices Regulation. This will make certain requirements more proportionate for devices on that list, to reduce the burden on manufacturers, in line with the Commission’s simplification agenda.
The list of WET devices included in these delegated acts was developed in 2025 by a dedicated Task Force of national experts from the Medical Device Coordination Group (MDCG), following a call for evidence that allowed stakeholder input.
Now that the implementing acts have been published in the Offical Journal, they will enter into force in 20 days time.
Excerpt from the official page. The original is authoritative.