
Aug 16, 2021
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...
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Mar 19, 2021
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...
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Feb 11, 2020
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...
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Jan 16, 2020
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,...
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Jan 14, 2020
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...
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