Nearly four months after the full application date of the EU’s Medical Device Regulation, the EU standards bodies have updated the most critical medtech standard to align it with the new EU medtech regulations.
The European standards bodies, CEN and Cenelec, have published an update to the EU medical quality management system standard to link it for the first time with the new Medical Device and IVD Regulations.
EN ISO 13485:2016+A11:2021 features new annexes demonstrating the link between specific clauses of the standard and the general safety and performance requirements (GSPR) of the MDR and IVDR.
An EN ISO standard is an international standard that has been adopted at the level of the EU. The differences are outlined in the foreword and annexes to the EU document which make the link with EU requirements.
