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, the present guidance was developed 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

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