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Old 11th July 2018, 10:52 AM
Marcelo Antunes's Avatar
Marcelo Antunes

Total Posts: 3,363
re: Clinical investigation - Role of Notified Body (NB)

Just to prevent confusion, you mean performance study, right? Clinical investigation is only applicable to non-IVD devices. The related term that applies to IVDs are performance studies.

The basic NB role is to verify that the conformity assessment route applied by the manufacturer was followed. Performance studies (or clinical investigations in the case of non-IVD devices) are not part of the conformity assessment per se, because they are mainly ways to generate data for the performance evaluation (or clinical evaluation in the case of non-IVD devices.

The performance study or clinical investigation is treated directly with the regulatory authority of the member-state it's being performed.

As to when the NB will be aware of the performance study...well, it depends. If you read the IVDR (for example, search the pdf document for "performance study") you will see that there's no requirement to inform the NB of any performance study, what they have to do is to evaluate the clinical data of your performance evaluation, which may include data from performance studies.

But in practice they may be aware (they will probably ask, for information's sake) about any performance study your device is undergoing.
Thank You to Marcelo Antunes for your informative Post and/or Attachment!

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