EU Publishes Guidance on In Vitro Diagnostic Devices

By Ken Pilgrim and Evangeline Loh
 

The various MEDDEV guidance associated with the Directives has been tremendously helpful before and even after the IVDR’s release. One such guidance has finally been released by the MDCG for the IVDR (EU) 2017/746 - MDCG 2024-11—Guidance on qualification of in vitro diagnostic medical devices.

Background on MDCG 2024-11

The European Commission (EC) Medical Device Coordination Group (MDCG) has released guidance (MDCG 2024-11, Oct. 8,) on IVDs.

To those familiar with the previous guidance for the IVD Directive (IVDD 98/79/EC), MEDDEV 2.14/1, Rev. 2, January 2012, Guidelines on IVD Medical Device Borderline and Classification Issues, much of the content from that document has been incorporated into MDCG 2024-11.

Organization of MDCG 2024-11

The guidance maintains its organizational structure - Section 1 discusses the general principles of qualification of an IVD: definition of IVD, used alone or in combination, in vitro examination for a human body specimen, used in vitro for the assessment of a specimen, and principal intended purpose to provide IVD medical purpose. In the MDCG, the principal intended purpose is discussed more extensively.

Section 2 on specific qualification topics is more elaborate in the MDCG. Some of the topics in Section 1 of the MEDDEV have been added to this Section. Of course, the MEDDEV Part B on classification has been removed.

What’s new in MDCG 2024-11?

As expected, there are new topics added to Section 2, Section 2.8 Software, and Section 2.11 Tests to be used in manufacturing control. Certainly, the software can be an IVD, and if standalone software provides information on the results derived from IVDs, it can be an IVD as well, even if it does not “analyze the human specimens directly.” Tests used to monitor the manufacture of products (the example provided is for medicinal products) should not be IVDs. Curiously, the comparison and examples of PCR machines, which are general laboratory use products or IVDs, have been deleted.

Some additional (non-exhaustive) examples are included to make the guidance relevant to the current state of the art.

Concluding remarks

The previous MEDDEV guidance on qualification of an IVD was seminal to the IVDD 98/78/EC. This new MDCG guidance is now available for reference to the IVDR; however, it is predominantly the same content as the MEDDEV with some slight modifications.