It clarifies the qualification criteria for in vitro diagnostic medical devices (IVDs) and their accessories, based on their intended purpose as described by the manufacturer, and outlines the definitions, essential characteristics, and specific qualification topics related to IVDs, including specimen receptacles, products for general laboratory use, IVD kits, calibrators, control materials, software, and more.

MDCG 2024-11: Guidance on qualification of in vitro diagnostic medical devices

Some key takeaways from MDCG 2024-11:

More than one specimen receptacle may be involved in the collection, transport and storage of an individual specimen. In such cases the manufacturer of each receptacle must have evidence of compliance with the IVDR. However, products that are specifically intended for the primary containment and preservation of specimens derived from the human body but merely to transfer specimens should not be qualified as an IVD. All invasive (within the meaning of the MDR) specimen collection devices or those which are directly applied to the human body for the purpose of obtaining a specimen are regarded as medical devices within the scope of the MDR.

Products for general laboratory use cannot be qualified as IVDs merely by adding the statement “for in vitro diagnostic use”; they must possess specific characteristics that make them suitable for one or more identified in vitro diagnostic examination procedures. As such, general centrifuges, general purpose pipettes, general plastic tubes, general PCR machines, ELISA readers providing only peaks or OD values, etc… should not be qualified as IVDs whereas haematocrit centrifuges, coagulation pipettes with automated timing, urine specimen containers, PCR machines intended for IVD purposes, bacteria density readers intended for IVD purposes, etc… are covered by the IVDR. Microbiological culture media and stains used in histology, cytology and microbiology are covered by the IVDR only if they are specifically intended to provide information concerning a physiological or pathological state on specimens derived from the human body.

An IVD kit is an IVD in itself. IVD kits may contain only IVDs and accessories, or a combination of IVDs and medical devices (CE marked in accordance with the MDR), products for general laboratory use, food products… IVD kits may however not include medicinal products. An IVD kit is also different from a procedure pack: a procedure pack, containing products of which at least one medical device packaged together with the purpose of being used for a specific medical purpose, should not have an intended purpose that corresponds to Article 2(2) of the IVDR.

Devices incorporating, as an integral part, a medical device are governed by the MDR while the requirements of the IVDR apply to the IVD part. Medical devices merely packaged together with an IVD, and detachable medical devices packaged together with an IVD are however not considered integral products.

What does it mean to you?

MDCG 2024-11 is crucial for all manufacturers uncertain whether their products are covered by the IVDR, the MDR, or neither of both as this guidance offers further clarification on the definition of an IVD.