EU MDR/IVDR The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for regulations in the sphere of medical devices, has published guidance for notified bodies, distributors, and importers on certification activities in accordance...
EU MDR/IVDR SwissMedic, the Swiss regulating authority in the sphere of medical devices, has published a guidance document dedicated to the obligations of parties involved in operations with medical devices, other than manufacturers: authorized representatives, importers, and...
EU MDR/IVDR The European Medicines Agency (EMA) has published guidelines dedicated to the quality documentation to be provided for medicinal products intended for use with medical devices. The present article addresses matters related to medicinal products with co-packaged or...
EU MDR/IVDR The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices regulations, has published a guidance document dedicated to the performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices. Please...
EU MDR/IVDR The European Medicines Agency (EMA) has published guidelines on quality documentation for medicinal products when used with a medical device. The provisions of the guidance are based on the following regulations: Directive 2001/83/EC (the Medicinal Products Directive)...
EU MDR/IVDR The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices’ regulations, has published a guidance document dedicated to the integration of the UDI within an organization’s quality management system. Table...
