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Old 11th July 2018, 10:28 AM
HeatherC-S

 
 
Total Posts: 15
Question Clinical investigation - Role of Notified Body (NB)

Hello

I am working towards CE marking of Class IIb device under the new IVDR, and am wondering what the role of the NB is during the clinical investigation/trial stage as part of the CE marking process.

Obviously our competent authority will be notified and cleared to perform the clinical investigation, as well as updating them of adverse events, results etc.

When the technical file (including the report of the investigation) is submitted to the NB, is this the first time they will be aware of it?

Many thanks

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