A contract with the Notified Body must be signed by September 26, 2024.
The contract determines when the technical documentation must be submitted to the Notified Body. It aims to ensure sufficient time for review and, if necessary, the correction. Late or delayed submissions carry a high risk that timely CE marking will not be possible.
Device certification under MDR for legacy devices must be completed before December 31, 2027 for Class III devices and implantable Class IIb devices and before December 31, 2028 for other devices, except custom made class III implants and for Annex XVI products.
This implies that manufacturers must submit their Technical Documentation early enough, so that the Notified Body can perform the review and potential nonconformities can be closed.