Theme IVDR Codes
Target Audience

Notified bodies, Manufacturers

Products concerned


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.