Medical device CE marking

MDCG 2021-27 Revision 1 published


On December 19, 2023, the European Commission published revision 1 of the MDCG 2021-27: on “Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746”.

This document presents questions and answers on requirements related to importers and distributors under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The term ‘devices’ will be understood to include medical devices, accessories for medical devices, products listed in Annex XVI of the MDR, in vitro diagnostic medical devices and accessories for in vitro medical devices.

The revision 1 can be downloaded in our library

Source: European Commission