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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. It should also help to reduce medical errorsand to fight against falsified devices . Use of the UDI system should also improve purchasing and waste disposal policiesand stock-managementby health institutions and other economic operators and, where possible, be compatible with other authentication systems already in place in those - Copyright USDM Life Sciences - 2017 BaltimoreJune 2017 Presented by:Jay CrowleyVP of UDI Services and SolutionsUSDM Life EU MDR and IVDR UDI Requirements8 June 2017 BaltimoreJune 2017 IMDRF Guidances Goal Largely

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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