Europe
The article provides an overview of the implementing decisions issued by the European Commission for harmonized standards allowed to be applied in the context of general and in vitro diagnostic medical devices under the new regulatory framework. Table of...
COVID-19
The European Commission (EC) responsible for medical devices regulatory framework has published an official notice informing about its proposal to roll out the new In Vitro Diagnostic Medical Devices Regulation to ensure uninterrupted availability of vitally important...
EU MDR/IVDR
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...
Europe
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s regulating authority, has initiated a public consultation regarding the regulatory framework for medical devices. In particular, the authority encourages medical device manufacturers and other...
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...
