Class III Implantable Custom-Made Devices: Extension Period Ends
May 26
Class III implantable custom-made devices (CMDs) must comply with the MDR in order to continue being placed on the market, i.e., the device must possess a conformity assessment certificate issued by a Notified Body.
The extension period ends per MDR Article 120(3f):
“By way of derogation from Article 5, class III custom-made implantable devices may be placed on the market or put into service until 26 May 2026 without a certificate issued by a notified body in accordance with the conformity assessment procedure referred to in Article 52(8), second subparagraph, provided that no later than 26 May 2024, the manufacturer or the authorised representative has lodged a formal application with a notified body in accordance with Section 4.3, first subparagraph, of Annex VII for conformity assessment, and, no later than 26 September 2024, the notified body and the manufacturer have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII.“