Sign Agreement with Notified Body: MDD/AIMDD Legacy Devices

Manufacturers of MDD/AIMDD legacy devices must have a signed written agreement with a Notified Body by today.

This is outlined in the MDR Article 120(3c)(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.“