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EU Medtech Ecosystem Will Suffer Unless Notified Body Workload Concerns Are Addressed – The German View

 
• By Ashley Yeo

An EU notified body redesignation rate of 10 per year is too slow. It won't help small companies using the new Medical Device and IVD Regulation systems, and is leaving NBs feeling let down and with a mountain to climb. A German industry group weighs in on the need to speed up redesignations.

A common complaint during the promulgation of the twin EU Medical Device and IVD Regulations was that the process was talking too long. They finally came into force in May, but the wait goes on for notified bodies who are unable to work under the regulations until redesignated. Under the terms of the MDR and IVDR, notified bodies are unable to apply for redesignation until November 26, 2017.

With the three- (MDR) and five- (IVDR) year transition periods already eroding, the tension among NBs and manufacturers alike is...

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