| Theme | Certificates |
| Target audience | Notified Bodies (NB) |
| Products concerned | MD, IVD |
| Regulatory references | MDR (EU) 2017/745
Article 58(1) IVDR (EU) 2017/746 Article 53(1) |
| Documents mentioned |
This guide provides additional information on the content of certificates of conformity. It clarifies that it is not necessary to include a reference to common specifications or relevant harmonized standards as long as information on the assessments and tests performed is traceable and available.
In addition, the guide specifies the conformity assessment activities to be carried out by the NB in the context of a certificate transfer.