Apr 23, 2020
Europe
The European Commission, the EU authority responsible for medical device regulation, issued guidelines dedicated to the diagnostic tests used in the context of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus”. The...
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Apr 7, 2020
COVID-19
The European Commission (EC), the European authority responsible for medical devices regulation, issued guidance dedicated to medical devices, active implantable medical devices, and in vitro diagnostic medical devices in the context of Coronavirus Disease 2019...
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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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Dec 13, 2019
Europe
The Medical Device Coordination Group (MDCG), the advisory body assisting the European Commission on issues related to the implementation of legislation regulating the circulation of medical devices, has published several guidances. MDCG Issued New Guidance Regarding...
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Nov 27, 2019
Europe
The Medical Device Coordination Group (MDCG) of the European Commission (EC) issued a final version of the assessment form intended to be used by designated authorities to select a notified body. Notified Bodies and Conformity Assessment Bodies The MDCG, an...
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