MDCG 2022-16 : Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) – October 2022

9 Nov 2022 | All the News, MDCG, MDCG

Theme Authorised representatives’ obligations
Target Audience Authorised representatives, Manufacturers and other economic operators
Products concerned MD/IVD
Regulatory reference MDR (EU) 2017/745
IVDR (EU) 2017/746
Documents mentioned

MDCG 2019-7
MDCG 2019-13
MDCG 2021-1
MDCG 2021-3
MDCG 2021-25
MDCG 2021-27
MDCG 2022-8
MDCG 2022-12

EUDAMED: Economic Operator user guide How economic operators can use the actor registration module
Directive 85/374/EEC
Blue Guide

 

This MDCG document clarifies the requirements for European Authorized Representatives (EC REP) acting on behalf of manufacturers located outside the European Union. Clarifications and details are given to the articles relevant to authorised representatives in the European regulations (MD and IVD) and to the previously published MDCG guidances. Several topics are covered, including designation procedures, registration requirements and the obligation to have a Person Responsible for Regulatory Compliance (PRRC).