EC: Guidance on Qualification of IVDs
The European Commission (EC) Medical Device Coordination Group (MDCG) has published guidance on qualification of in vitro diagnostic medical devices (IVDs) (MDCG 2024-11). The guidance determines which products fall under the scope of Regulation (EU) 2017/746 (IVDR) as IVD.
Much of the content of the previous version MEDDEV 2.14/1, Rev. 2, January 2012, Guidelines on IVD Medical Device Borderline and Classification Issues, has been incorporated into the new guidance.
New topics have been added to Section 2, e.g. Section 2.8 Software, and Section 2.11 Tests to be used in manufacturing control. Software may fall within the scope of the IVDR. It can be qualified either an IVD software or a medical device software.
Tests used to monitor the manufacture of medicinal products should not be qualified as IVDs as they do not have a medical purpose as outlined in the IVDR. Some additional examples are included to make the guidance relevant to the current state of the art.
Sources:
EC: MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices
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