There has been an update in the guidance document MDCG 2021-5 concerning the standardisation for medical devices. The guidance document was initially released in 2021 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.
Some of the changes featured in the updated guidance are the following:
- Removal of references to the Directives and integration into those to the Regulations
- General Update of footnotes and links
- Addition of references: Communications, Guidelines,“Task Force”
- Addition of considerations on the references to EN ISO 15189 and ISO 14155:2011
- Addition of references to the MDR/IVDR standardisation request and its amendments
- Addition of considerations on information and clarificationby CEN and CENELEC and their Technical Committees
- Updates on the IMDRF
- Updates on the “state of the art”
- Additions and updates of references and links
The updated guidance can be accessed using the following link
