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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Nov 1, 2019
EU MDR/IVDR
According to the information available, the implementation of Eudamed database could possibly be delayed for 2 years. Information on the delay was published for the first time after the medical device forum that took place in Hamburg. Eudamed: the Scope and Purpose...
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