| Theme | IVDR Codes |
| Target Audience |
Notified bodies, Manufacturers |
| Products concerned |
IVD |
| Documents mentioned |
IVDR (EU) 2017/746 Commission Implementing Regulation (EU) 2017/2185 MDCG 2019-11 |
This document provides details of the designation codes for Notified Bodies (NB) under the In Vitro Diagnostic Medical Devices Regulation 2017/746, provided by Commission Implementing Regulation 2017/2185.
These codes are also used by NB to describe the individual qualification of NB staff as well as to describe the qualification required to assess a device.