EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, the regulating authority in the sphere of medical devices, has published questions & answers on clinical investigation. Please note that the document does not represent the...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, the EU regulating authority in the sphere of medical devices, has published updated guidance on standardization. Due to its legal nature, the document should neither be treated...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, has published a guidance document dedicated to the application of transitional provisions for certification of class D in vitro diagnostic medical devices according to the In...
EU MDR/IVDR
Swissmedic, the Swiss regulating authority in the sphere of medical devices, has published an official notice describing upcoming changes in applicable regulatory requirements. The announced changes related to the procedures to be performed when placing new medical...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission (EC), focused on further improvement of medical device regulations, has developed a guidance document dedicated to the state of the art rapid antibody tests intended for use in...
EU MDR/IVDR
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document detailing how medical device accessories should be described in submissions. The document also provides additional...
