Lodge Notified Body Application & Implement MDR Compliant QMS

By today, manufacturers of MDD/AIMDD legacy devices must have:

1. implemented a quality management system as outlined in MDR Article 10(9)
2. formally lodged an application with a Notified Body for the device. 

Otherwise, the device no longer qualifies as a legacy device under the extension. This is noted in the MDR, Article 120(3c): “(d) no later than 26 May 2024, the manufacturer has put in place a quality management system in accordance with Article 10(9); (e) 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 in respect of a device referred to in paragraph 3a or 3b of this Article or in respect of a device intended to substitute that device, 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. “

Additional conditions apply, such as those noted in Article 120(3d): “…the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply to devices referred to in paragraphs 3a and 3b of this Article in place of the corresponding requirements in Directives 90/385/EEC and 93/42/EEC”

NOTE: Class III implantable custom-made legacy devices are not required to implement an MDR to the QMS by this deadline. However, they are required to have formally lodged an application with a Notified Body by this date. This is noted in 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.”