The European Commission has published two delegated acts on Well-Established Technologies (WET) under the Medical Devices Regulation (EU) 2017/745 (MDR) in the Official Journal of the European Union.
Well-established technologies (WET) are medical devices with:
✅ Common and stable designs
✅ Well-established safety and clinical performance
✅ A long history of safe use on the market
The newly published delegated regulations expand the list of WET devices, making certain MDR requirements more proportionate. This aims to reduce the regulatory burden on manufacturers while maintaining high standards of patient safety, in line with the European Commission’s simplification agenda.
The updated list was developed in 2025 by a dedicated Task Force of the Medical Device Coordination Group (MDCG) following a public call for evidence and stakeholder consultation.
📅 The delegated regulations will enter into force 20 days after their publication in the Official Journal.
The published regulations are:
📄 Commission Delegated Regulation (EU) 2026/1451 – amending Regulation (EU) 2017/745 regarding the list of implantable devices and Class III devices exempted from the obligation to perform clinical investigations.
🔗 Official Regulation
📄 Commission Delegated Regulation (EU) 2026/1359 – amending Regulation (EU) 2017/745 regarding the list of Class IIb implantable devices exempted from the obligation to undergo an assessment of the technical documentation for every device.
🔗 Official Regulation
Manufacturers of affected devices should review these updates to determine whether their devices qualify for the revised requirements and how these changes may impact their regulatory strategy.
