Regulation 2023/607 PublishedApril 7, 2023
Have Signed Agreement with Notified BodyApril 13, 2023
By today, manufacturers of MDD/AIMDD legacy devices must have:
- implemented a quality management system as outlined in MDR Article 10(9) and
- formally lodged an application with a Notified Body for the device. Otherwise, the device no longer qualifies as a legacy device under the extension.
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.