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MDR Date of Application Roundup: The New Landscape for Medical Device Manufacturers

A session by Evangeline Loh
VP, Regulatory Affairs, Emergo by UL

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About this session

The Medical Device Regulation (MDR) 2017/745 Date of Application heralded the MDR and the obsolescence of the MDD (and AIMDD). Certain critical topics may still lack regulatory clarity despite new documents and support services to help manufacturers adjust to the new regulatory environment.

The presentation will provide an update (including a review of resources developed by the European Commission) on the following:

• Standards

• European Medical Device Nomenclature

• EUDAMED

• Unique Device Identification

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