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...
MDCG The Medical Device Coordination Group (MDCG), an advisory body of the European Commission comprised of the representatives of all Member States, has published a guidance document dedicated to harmonized administrative practices and alternative technical solutions...
EU MDR/IVDR Statens legemiddelverk, the Norwegian Medicines Agency, issued an official notice to warn all parties involved in operations with medical devices that have been delayed in the launch of the new European database – EUDAMED. EUDAMED Delay EUDAMED is a database...
EU MDR/IVDR MedTech Europe, the association of companies that operate on the medical device market, is deeply concerned with the current situation regarding the implementation of Regulation 2017/745 (MDR). The association warns medical device manufacturers, importers,...
EU MDR/IVDR The European Commission (EC) has released two new guidance related to the nomenclature of medical devices. CND Nomenclature: Key Points The first document published by the EC describes the “Classificazione Nazionale Dispositivi medicini” or the CND – the official...
