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.
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.
📄 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.
https://lnkd.in/dXd2rZcM
📄 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.
https://lnkd.in/dv6-DXix