The latest developments in the implementation of the medical devices and IVD medical devices Regulations (MDR & IVDR) brought significant changes in the transitional phase for legacy devices. Particularly, an important amendment to Article 120 of the Medical Devices Regulation (MDR) prolonged the time legacy devices can be placed on the EU market. However, one main requirement to be subject to this automatic extension is having a conformity assessment application by 26 May 2024 and a signed agreement with the Notified Body by 26 September 2024.
In this respect, on 7 May 2023, Team-NB (the European Association for Medical devices of Notified Body) published the confirmation letter that notified bodies, manufacturers, and other economic operators can use to prove the application.
Update from 25 May 2025: the European Commission published the same template for the confirmation letter in the framework of the latest extended provisions.
Notified Body Confirmation Letter
Notified bodies can use this Letter to state that they received a formal application and signed a written mandate with a manufacturer. Moreover, the document includes the following:
- List of devices covered.
- Confirmation that the manufacturer signed the written agreement under MDR by the date of MDD/AIMDD certificate expiry (where applicable).
- Evidence that a Member State’s competent authority granted a derogation or exemption from the applicable conformity assessment procedure (where applicable).
- Transition timelines according to the latest changes.
Therefore, this harmonized template will assist manufacturers in complying with the requirements set under the extended MDR transitional periods. For further information, European Commission’s on Q&A on extension of the MDR transitional period and removal of the “sell off” period provides further guidelines on the application of the new extensions.
You can find this and other relevant documents in our Library of Documents.