Medical device CE marking

Notice to manufacturers to ensure timely compliance with MDR requirements

2022-06

The European Medical Device Coordination Group has issued a position paper concerning the transition to the MDR.

Many MDD certificates will expire in 2023 and 2024. In order to be in time for MDR certification, it is necessary to submit the MDR technical documentation well in time before the MDD certificate expires. This also applies to devices which are up-classified and require a NB-assessment under the MDR. The grace-period for these devices ends on the 26th of May 2024. Discuss the procedure and timeline with your Notified Body. Currently there are 30 Notified Bodies accredited: NANDO database

The document can be downloaded in our library

Source: European Commission