Transcription of Unique Device Identification (UDI) system… should ...
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Unique Device Identification (UDI) system… should ...
BaltimoreJune 2017A Regulation of the European Parliament and of the Council on [/in vitrodiagnostic] medical devices (approved by EP on 5 April 2017; published 5 May 2017 in the Official Journal of the EU; date of application 26 May 2020):Whereas: (41/38) The traceability of devicesby means of a Unique Device Identification (UDI) should significantly enhance the effectiveness of the post-market safety-related activitiesfor devices, which is owing to improved incident reporting, targeted field safety corrective actionsand better monitoring by competent authorities.
Baltimore June 2017 Presented by: Jay Crowley. VP of UDI Services and Solutions. USDM Life Sciences. jcrowley@usdm.com. The EU MDR and IVDR UDI Requirements
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