A new consolidated version of the MDR has recently been published. The new version incorporates the following delegated regulations:
- Commission Delegated Regulation (EU) 2026/1359 concerning the list of class IIb implantable devices exempted from the obligation to perform an assessment of the technical documentation for every device
- Commission Delegated Regulation (EU) 2026/1451 concerning the list of implantable devices and class III devices exempted from the obligation to perform clinical investigations
The new consolidated version of the MDR can be accessed using the following link
