How Notified Bodies Must Ensure Appropriately Qualified Staff Assess Each IVD

Notified bodies must have a system in place to ensure that IVD devices are assessed by individual staff and teams with adequate knowledge and expertise. EU guidance explains the criteria for notified bodies.

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The European Commission’s Medical Device Coordination Group has published a 17-page guidance document on IVD Regulation codes, MDCG 2021-14, to help notified bodies assign fully competent staff to the devices they are required to assess.

The guidance expands on Commission Implementing Regulation 2017/2185, which lists codes and the corresponding types of device for specifying notified body scopes under both the Medical Device Regulation and...

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