Persuant to question 5 of the Q&A released by the EU Commission, manufacturers need to demonstarte that the conditions for the extension are fulfilled by means of a self-declaration, similar to the form produced for the MDR extension. The self-declaration should also state the end date of the transition peroid and should clearly identify the devices covered by the extension and any certificates concerned.
as with the MDR extension, additional optional evidence may include a confirmation letter from the notified body, indicating receipt of the manufacturer’s application for conformity assessment and the establishment of a written agreement. Such confirmation should clearly identify the devices covered by the extension and certificates concerned.
The Self Declaration Template can be accessed using the following link
