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LiveWorx 2017

Getting Ready for the European Union (EU) Medical Device Regulation (MDR)

Session Description

During this presentation, Caroline Leab from Abbott and David Wolf from PTC, will review big changes that are coming for medical device manufacturers if they want to sell products into the European Union. The most significant changes in the proposed regulation include Product Scope Expansion, More Stringent Clinical Evidence, Identification of “Qualified Person”, Implementation of EU Unique Device Identification (UDI), Rigorous Post-Market Oversight and Specifications. There are different ways to tackle the changes when going from the EU’s current Medical Device Directive (MDD) to the new Medical Device Regulation (MDR). Your company might want to consider a mock audit in which you will review your technical file with a notified body.


Session Presenter
Additional Information
Security and Privacy
Healthcare & Medical Devices
Breakout Session
45 minutes
Session Schedule