The Medical Device Coordination Group has endorsed MDCG 2021-5 Rev. 1, a first revision of its now 27-page guidance on standardization for medical devices for use in the context of the EU’s Medical Device and IVD Regulations.
MDCG 2021-5 Rev. 1: EU’s Standardization Guidance Brought Up To Date
A new reference in the document reminds the medtech sector that EU harmonized standards remain voluntary to encourage innovation.
