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

The MDCG's latest document is intended to clarify what products fall in scope of Regulation 2017/746 (IVDR). In order to be qualified as an IVD or an accessory to an IVD, the product must fulfil the definition in Art 2(2) or Art 2(4) of the IVDR respectively. The qualification depends on the intended purpose as described by the manufacturer. This guidance document lists general principles of qualification and then provides non-exhaustive lists of examples of IVDs and accessories to IVDs. The guidance document also outlines the definitions, essential characteristics, and specific qualification topics related to IVDs.

Key takeaways:

• Specimen Receptacle: It is possible that more than one specimen receptacle is 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. A product intended to transfer the specimen, but which is not specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination, should not be qualified as an IVD. 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 must not be considered to be accessories to in vitro diagnostic medical devices (Article 2(4) IVDR). These products are regarded as medical devices within the scope of the MDR.
• Products for general laboratory use: If the product for general laboratory use does not possess specific characteristics that makes it suitable for one or more identified in vitro diagnostic examination procedures, then the manufacturer should not qualify the product as an IVD. Merely adding the statement “for in vitro diagnostic use” to a product is not sufficient to qualify a product as an IVD. Examples of products for general laboratory use and IVDs?are detailed in the guidance document.
• IVD kits: The definition of an IVD includes ‘kit’ as being an IVD in itself. IVD kits may not include medicinal products. Where an IVD is intended to be used with a medicinal product and the products are packaged together, this combination may not be qualified as an IVD kit. Each product must comply with its corresponding legislation. The qualification either as a ‘procedure pack’, according to the MDR or as a ‘kit’ according to the IVDR should be based on the intended purpose of the whole product combination. A procedure pack should not have an intended purpose that corresponds to Article 2(2) IVDR. A procedure pack must contain at least one medical device. If the whole product combination is qualified as a procedure pack, it should comply with the requirements set in the MDR. IVD components that are included in a procedure pack should fulfil the requirements of the IVDR.
• Devices incorporating, as an integral part, a medical device: An integral product consists of at least two constituent parts, one of which is an IVD, and the other is a medical device, which are physically combined in such a manner that they form a single object. Medical devices packaged together with an IVD component are qualified separately are not considered integral products and must respect the requirements of the MDR and IVDR respectively.

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Calibrators & Control Materials, Software, Microbiological Culture Media, Stains, and more are discussed in the guidance document.?

For manufacturers, this is a must-read to stay compliant and avoid delays in market access!

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?? Read the full guidance here