Explaining IVD Classification Issues

Explaining IVD Classification Issues

By bsi
Explaining IVD Classification Issues

To comply with the Regulation on in vitro diagnostic medical devices (2017/746) (IVDR) manufacturers must classify their in vitro diagnostic (IVD) devices in accordance with the rules set out in Annex VIII of the Regulation. There are some significant differences between the classification systems for medical devices and IVD medical devices under the new regulations.

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