EU Delegated Acts on well-established technologies published

Two delegated acts on well-established technologies (WET) under the Medical Device Regulation (MDR, 2017/745) have now been published in the Official Journal of the EU.

Well-established technologies are relatively simple devices, with common and stable designs that don’t evolve significantly, have well-known safety and clinical performance characteristics, with a long history on the market. The new delegated regulations expand the list of WET devices under the MDR to reduce the burden on manufacturers, in line with the Commission’s simplification agenda, by making certain regulatory requirements more proportionate to the devices concerned.

Now that the implementing acts have been published in the Offical Journal, they will enter into force in mid-July 2026.

• Commission Delegated Regulation (EU) 2026/1451 of 20 March 2026 . . . as regards the list of implantable devices and class III devices exempted from the obligation to perform clinical investigations.
• Commission Delegated Regulation (EU) 2026/1359 of 20 March 2026 . . . as regards the list of class IIb implantable devices exempted from the obligation to perform an assessment of the technical documentation for every device.