Notified Bodies – Total 27
With the advancing of time since the application of the Medical Device Regulations (EU) 2017/746, and as a preparation for the incoming In-Vitro Diagnostics Regulations (IVDR)
Recently, the industry witnessed the addition of a new notified body on the NANDO system and the total count has gone up to 27 Notified Bodies.
Over the years, the involvement of Notified Bodies in certifying medical technologies has evolved, and it is currently experiencing another significant revamp with the new CE Marking Regulations adopted in 2017.
This leads to a situation where fewer and fewer NBs have to deal with more extensive work. The gap between NBs’ capacity and the existing workload continues to increase significantly. According to the new Medical Device and In Vitro Diagnostic Regulations, Notified Bodies are undergoing a significant revamp to comply with their greater obligations.
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