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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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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Jun 19, 2019
EU MDR/IVDR
European Commission informed that as a result of implementation of medical device and in vitro diagnostic regulations, there could be an issue of availability of several types of devices. The root of the problem is due to some manufactureres deciding to suspend the...
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