The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a guidance document dedicated to the current classification rules. The document is intended to assist medical device manufacturers...
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a guidance document dedicated to the applicable classification rules. At the same time, the MDCG emphasizes that the document...
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...
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...
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...
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for regulations in the sphere of medical devices, has published an explanatory note on codes assigned under the In Vitro Diagnostic Medical Devices Regulation...