Theme Transitional provisions
Target Audience Manufacturers, Notified Bodies
Products Concerned MD,AIMD
Regulatory reference MDR (EU) 2017/745

Article 120

Documents mentioned CAMD FAQ – MDR Transitional provisions

This guide addresses article 120 of the MD Regulation, which allows certificates issued under the MD and AIMD Directives to retain their intended validity date, and no later than May 27, 2024.

During this “grace period”, the Notified Body (NB) that issued the certificate continues to be responsible for surveillance activities with respect to all requirements applicable to the device it certified, even if the NB ceases activity or is not designated under the MDR.

The MDCG specifies that the contract between the manufacturer and the NB should include provisions for these surveillance activities to be carried out.

Finally, the MDCG recalls that the information published in the NANDO database on the pages dedicated to the MD and AIMD Directives will become obsolete as from 26 May 2021, and that to this effect, a clear message will be mention that listed NB are no longer able to issue new certificates, but only authorized to carry out surveillance activities on valid certificates