| Theme | Notified Bodies |
| Target Audience | Notified Bodies |
| Products Concerned | MD, IVD |
| Regulatory reference |
MDR (EU) 2017/745 Annex VII IVDR (EU) 2017/746 Annex VII |
| Documents mentioned | NBOG 2017-2 |
In this document, the MDCG proposes in the form of questions and answers its interpretation of the regulatory provisions concerning Conformity Assessment Bodies (in particular Annexes VII of the regulations). Details are given on their legal status, responsibilities, organization and on the prevention of conflicts of interest in terms of recruitment, remuneration or the nature and name of the activities carried out with economic operators.
It was revised for the 3rd time in October 2021. The answers to questions I.6 and IV.4 have been revised. The changes to the answer to question IV.4 are typological and do not affect the meaning of the answer.