Use of Symbols to Indicate Compliance with the MDR
The Medical Devices Regulation 2017/745/EU (‘MDR’) has new requirements that ask for various kinds of information to be indicated on the label of medical devices. Originally, MedTech Europe developed a guidance to support compliance with labelling requirements of the MDR in a harmonised manner before the publication of ISO 15223-1: 2021 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements, which has now been published (July 2021). Therefore, the present guidance has been updated to align with the new ISO 15223-1:2021.
Posted on 06.05.2019