Introduction: scope and contents
This document aims to provide guidance on different aspects related to standards in the medical devices sector in support of the requirements laid down in the applicable EU legislation, taking into account its specificities. The contents of this document:
are not intended to be exhaustive, and must be read and used within the legal and guidance framework on EU harmonisation legislation for health, safety and performance of products in the internal market, in particular for European standardisation.
Wider information on such legal and guidance framework is available from the references and sources of information indicated in the footnotes and at the end of this document.
Update - MDCG 2021-5 Rev.1 - Guidance on standardisation for medical devices - July 2024
Update - MDCG 2021-5 Rev.1 - Guidance on standardisation for medical devices - July 2024
health.ec.europa.eu
