Background

The MDCG has published new IVD guidance, available: HERE

This guidance is essentially replacing the old IVDD guidance on the same topic – borderline issues for IVDs.

MEDDEV 2.14/1 rev. 2 ‘IVD Medical Device Borderline and Classification issues’, guidance under the IVDD, was published January 2012.

MDCG 2024-11 ‘Guidance on qualification of in vitro diagnostic medical devices’, newly published, covers much of the same content as the MEDDEV. However, it has been updated to reflect the IVDR.

MDCG 2024-11 vs MEDDEV 2.14/1 rev.2

The MDCG guidance roughly follows the same order as the MEDDEV, covering borderline issues around accessories, specimen collection devices, general laboratory products, IVD kits, and more.

Much of the content from the MEDDEV remains unchanged in the MDCG, outside of addressing obvious differences between the IVDD and IVDR, such as classification. And adding more clarification on some of the points, e.g., an individual subsection on ‘devices where no specimen is involved’.

The MDCG also includes some new sections. For example:

Image: MEDDEV on the left, MDCG on the right

Image: MEDDEV on the left, MDCG on the right