11
Nov
Compliance Update Alert: MDR introduces 22 new rules to classify medical devices
A comprehensive guide to medical device classification EU was published on October 20, 2021 by The Medical Device Coordination Group (MDCG). MDCG guidelines are detailed in a 57-page document, detailing how medical devices are classified, and providing rules to help […]
16
Jul
Everything you need to know about In Vitro Diagnostic Regulation – (IVDR)
The “In Vitro Diagnostic Regulation” (IVDR) is a new regulation by the EU applicable for In Vitro Diagnostic (IVD) Medical Devices. The IVDR came into effect on May 25, 2017, with a five-year transition period for manufacturers and suppliers. The […]
- The Compliance Solutions division of
