1st revision of the MDCG 2021-5 guidance on standardisation for medical devices

This document aims to provide guidance relating to the medical devices sector standards, in support of the requirements laid down in the applicable EU legislation. 

The revisions are made as following:  

• Removal of reference to directives and integration of those onto the regulations
• New considerations for the use of standards EN ISO 15189 and ISO 14155:2011
• New reference to the MDR/IVDR standardization mandate and its amendments
• Updates on the role of “state of the art” in the standardisation and its definition
• Additions of reference to the European Court of Justice rulings to the European Pharmacopoeia and to common specifications

DOWNLOAD MDCG 2021-5 Rev.1