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Based on the amount of questions we're receiving around the definition of a Well-Established Technology (WET), evidence suggests there's a lot of confusion and in turn, potential impact to the industry. The MDR didn't provide a definition, however, the MDCG-6 Guidance on sufficient clinical evidence for legacy devices now provides a definition and further details around sufficient clinical evidence for WET and non-WET devices. Even with this guidance, we're still seeing debate between device companies and their notified bodies on what is classified as WET.
In this show, we'll provide our current thinking on this debate and some tips for interacting with your notified body. As always, please bring your questions to the live discussion!
Here's the panel:
Ibim Tariah, Ph.D. — VP of EU MDR and IVDR Consulting Services (Former BSI Technical Director of Medical Devices through 2019; 21 years at BSI)
Nancy Morrison, RAC — Executive Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q
Jon Gimbel, Ph.D. — Executive Director, Regulatory and Quality Consulting Services, and technical leader of R&Q CER/PER team
Ron Sills — Senior Principal Specialist (Former TUV Rheinland Lead Auditor through 2019)