EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, focused on further improving the regulations in the sphere of medical devices, has published a new visual guide describing the approach to be applied when determining whether...
MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published updated guidance on in vitro diagnostic (IVD) medical devices intended for point of care use. The initial version of the...
Europe
What is IVD/IVDR In Vitro Diagnostic (IVD) medical devices are intended for examining specimens of the human body to either provide information on the physiological state of the patient or to monitor therapeutic measures. They could also be used to define the...
EU MDR/IVDR
European medical device regulating authority, the European Commission, issued two additional guidance. They expand on certain application aspects of Medical Device Regulation and in vitro Diagnostic Device Regulation. The new documents include important changes and...
Consultant Post
Katrina is a U.S. medical device regulations consultant on the east coast with in-depth knowledge of the Medical Device Industry. Katrina has been a consultant with RegDesk for a while now and we recently had the chance to catch up! REGDESK: Did you have any...
