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 Realized 3 BaltimoreJune 2017 The Evolving UDI Global LandscapeCONFIDENTIAL - Copyright USDM Life Sciences - 20164US UDIEU MDRUK NHSR egulatoryRequirements Commercial or (Ministry of) Health/Cost/Impo

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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