Update of MDCG 2021-5 Guidance on Standardisation of Medical Devices
3 July 2024
On 2 July 2024, the Medical Devices Coordination Group (MDCG (EN)) published the updated guidance document MDCG 2021-5 Rev.1 on various aspects of medical device standards in support of the requirements set out in the applicable EU legislation.
The main changes are summarised in tabular form on page 2 of the document MDCG 2021-5 Rev. 1, including i.a. the following points:
- Removal of references to old directives and inclusion of references to updated regulations and directives,
- Updating the “state of the art”,
- Addition of references to EN ISO 15189 and ISO 14155:2011,
- Addition of references to the MDR/IVDR standardisation proposal and its amendments,
- Updates from IMDRF,
- Information and clarification by CEN and CENELEC.
This document is essential for regulatory compliance and meeting health, performance and safety standards in the medical device industry.
