Research assistant Nicole Gebert contributed to this article. Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition ...
The European Commission’s Medical Device Coordination Group (MDCG) issued new guidance providing recommendations for integrating unique device identification (UDI) processes within a manufacturer’s ...
The European Commission just published an “implementing measures rolling plan” in relation to the MDR and IVDR which are scheduled to apply from 26 May 2020 and 26 May 2022 respectively. New guidance ...
The European Commission on Friday released three documents, including two on the Medical Device Regulation (MDR) and the In Vitro Diagnotic Regulation (IVDR) and what data from the unique device ...
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