The Medical Device Coordination Group (MDCG) released its guidance on the qualification of in vitro diagnostic devices, MDCG 2024-11, in October 2024. This document serves as a successor to the well-established MEDDEV 2.14/1 guidance, which focused on IVD borderline and classification issues under the IVD Directive. While MDCG 2024-11 delivers more examples and addresses new developments such as the growing field of non-medical applications of genetic or metabolic tests, it largely mirrors its predecessor, leaving many existing issues unaddressed.
Certain cases highlighted in the guidance call for deeper discussion and nuanced interpretation, particularly considering obligations imposed by the In Vitro Diagnostic Regulation (IVDR) on manufacturers as well as health institutions producing in-house IVDs. The IVDR has significantly expanded the requirements for performance evaluation, risk classification, and post-market surveillance, prompting a need for more detailed regulatory frameworks.
Progress on IVDR Alignment, but Gaps Remain
Among the updates, MDCG 2024-11 addresses ancestry tests and tests intended for sport, well-being, or lifestyle purposes, explicitly excluding them from the scope of the IVDR unless they serve an additional medical purpose. Similarly, it reaffirms that drug abuse tests used in forensic settings also fall outside the IVDR’s scope under these conditions. The guidance provides more extensive examples of IVD devices and offers clarification on the application of new provisions concerning devices that incorporate a medical device as an integral part.
One area that remains less updated and somewhat unsatisfactory is the section on products for general laboratory use. With the new requirements of Article 5(5) IVDR for in-house IVD manufacturers, it is essential to provide a clear and precise distinction between products that are unlikely to qualify as IVDs – such as general laboratory pipettes – and equipment routinely used as in-house IVD solutions, which may eventually need to be replaced by CE-marked counterparts.
MDCG Guidance Misalignment: Clarifying the Classification of Laboratory Instruments
A concerning issue arises from the apparent misalignment between MDCG 2024-11 and MDCG 2020-16. For example, while MDCG 2024-11 lists a "general PCR machine" as an example of general laboratory equipment, MDCG 2020-16 considers a "PCR thermocycler," without further indication or specification, as a Class A IVD. This discrepancy begs the question: what’s the difference?
MDCG 2024-11 does not address the fact that many laboratory instruments, such as clinical chemistry analysers, PCR thermocyclers, and next-generation sequencers, are often used with reagents from various manufacturers and serve broad intended purposes. Despite their general classification, these instruments for routine diagnostic applications and IVDs through usability engineering, application of a software lifecycle process, and risk management. Their broad intended purpose justifies their Class A status, unlike reagents and instruments with a specific intended purpose, which are subject to higher classifications. One potential distinguishing factor is whether the instrument processes raw data to generate a result. This however needs more elucidation on behalf of MDCG.
Room for Improvement in Navigating Regulatory Demands and Practical Realities
Another challenging issue lies in distinguishing between an IVD kit and a procedure pack. MDCG 2024-11 asserts that a combination of products cannot qualify as an IVD if it is to be considered a procedure pack. While this interpretation aligns with regulatory principles, it places a significant burden on economic operators assembling specimen collection kits.
For instance, combining an analyte-specific ELISA plate with a new calibrator or buffer indisputably creates a new product requiring a full conformity assessment. However, assembling a lancet or stool collection sheet with a specimen receptacle is an entirely different scenario. Such combinations are unlikely to introduce major new risks, provided they meet the requirements of Article 22 of the MDR. This includes ensuring that the manufacturer’s information is included and the specifications for the combination are adhered to. This distinction is critical to reduce unnecessary regulatory burdens while maintaining safety and compliance.
Specimen collection kits are costly to produce, leading many manufacturers to supply large packs of individual devices instead. As a result, the task of assembling specimen collection kits often falls to economic operators closer to end users, such as distributors and medical laboratories, to better address the needs of healthcare practitioners and patients. Requiring these operators to implement a full manufacturer’s quality management system (QMS) and appoint a Person Responsible for Regulatory Compliance (PRRC) appears disproportionately demanding.
Anticipating Future Revisions
In summary, while MDCG 2024-11 builds on the solid foundation of MEDDEV 2.14/1, further updates are essential to address the evolving landscape of in vitro diagnostics. These updates must balance safety and compliance with the practical realities of the field while keeping user and patient needs at the forefront.
