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Location: MedTech Theater
Title: Conformity Assessment Process MDR (EU) 2017/745 including regulatory update / timelines
Event Type: Show Floor Education
This presentation is an overview of the activities and process medical devices manufacturers must undergo to sell their products on the European market. Topics covered will include an overview of services offered by TUV USA / TÜV NORD CERT, the basic overview of obtaining certification, the timelines set by the EU Commission in regards to MDR certification, and what obstacles manufacturers must overcome in order to complete certification and put their products on the market. Obstacles will be outlined and include changes to the classification of medical devices, changes to the general safety & performance requirements (GSPR) required under MDR, changes to clinical trials and equivalent devices, and more.
