The 6-Step Checklist For IVDR Compliance
The 6-Step Checklist For IVDR Compliance By Hilde Viroux and Hans Mische, PA Consulting The in vitro diagnostic devices industry has until May 25, 2022 to bring products, documentation, and quality management systems into compliance with the new EU Regulation on In Vitro Diagnostic Devices 746/2017 (IVDR). This regulation is a major revision, focusing on patient safety, requiring more clinical evidence, improving traceability in the supply chain, and enforcing a proactive post-market surveillance system to ensure early detection of problems. The past year presented a challenge in implementing...
Source: meddeviceonline.com