The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices intended to be marketed and used in the EU, has published a joint implementation and preparedness plan for the In Vitro Diagnostic medical devices...
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...
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...
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...
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...