The Medical Device Coordination Group (MDCG) released MDCG 2024-11, a new guidance to support the qualification of in vitro diagnostic medical devices and assess whether devices are IVDs. IVDR classification is based on rules, set out in Article 47 and Annex VIII. Together with the provisions and definitions provided in Articles 1 and 2 of the IVDR, manufacturers of IVDs must take into account essential characteristics of an IVD and specific qualification aspects.
Essential characteristics of an IVD
Overall, an IVD is classified as such under the IVDR when the device:
- Can be a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system.
- Can be intended to be used either alone or in combination with other devices or products.
- Is used in vitro (not in contact with the human body) for the examination of a specimen derived from the human body, and not reintroduced to the body.
- Is used to solely or principally provide information for one or more medical purposes as follows: information concerning a physiological process or state, a pathological process or state, congenital physical or mental impairments, predisposition to a medical condition or disease as well as information to to determine the safety and compatibility with potential recipients, to predict treatment response or reactions, to define or monitor therapeutic measures.
Specific qualification topics
The guidance document lists different specific aspects which concern the classification of IVDs.
Accessories: an item which is itself not an IVD is an accessory to the IVD when it is used together with an IVD to enable the device to be used in accordance with its intended purpose.
Specimen receptacles: an item 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. “Primary” does not necessarily mean the first container, while the word “preservation” implies the specimen’s protection (e.g., from light).
Products used for the collection of specimens: 1) a product without intended direct contact with the human body intended to transfer the specimen, but not intended for primary containment and preservation (e.g. plastic pipettes to transfer blood drop from finger to measuring device). Such products are not IVDs. 2) a product with intended direct contact with the human body for invasive specimen collection (e.g., needles, mouth tubes). Such products are medical devices and regulated by the MDR.
Devices where no specimen is involved: when a diagnostic device functions without the need of a specimen, the device is not an IVD (e.g., MRI scanner). Such devices are medical devices and regulated by the MDR.
Products for general laboratory use: a product for general laboratory use is classified as such when it possesses specific characteristics that make it suitable to be qualified as an IVD. The simple statement “for in vitro diagnostic use” is not sufficient for its qualification as an IVD. Overall, products for general laboratory use used in vitro in the specimens’ preparation obtained for an examination (e.g. paraffin, stains) are neither IVDs nor accessories. Such items would be considered as IVD or accessories to an IVD only when the item has been intended by the manufacturer to be used for in vitro diagnostic examination or the item fulfils the definition of accessories.
Products for research use only: the IVDR does not apply to products for research use only. Such devices cannot have a medical purpose.
Combinations of products placed on the market together: components’ packaged together can be treated as a kit under the IVDR. A kit with an intended purpose falling within the definition of an IVD may contain:
- Only IVDs and accessories (CE marked in case the IVDs are made available as separate device, too)
- Combination of IVDs and medical devices, other products (e.g., general laboratory use products), food products
Devices incorporating, as an integral part, a medical device: an integral product consists of at least two parts: an IVD and a medical device. Such products are combined in such a manner that they form a single object (e.g., swabs with integrated reagents). The MDR applies to such products, while the IVDR covers the in vitro diagnostic aspects.
Calibrators and control materials: Calibrators and control materials can be IVDs. Internationally certified reference materials and materials used for external quality assessment schemes are not IVDs according to the IVDR.
Microbiological culture media: Culture media or components of culture media fall within the scope of the IVDR when intended by the manufacturer to provide information concerning a physiological or pathological state on human specimens.
Stains: Stains used in histology, cytology and microbiology fall within the scope of the IVDR when intended to provide information concerning a physiological or pathological state on human specimens.
Tests intended to be used in manufacturing process control: Such products do not fall within the scope of the IVDR because they do not have a medical purpose.
Tests intended to be used in the context of biological or chemical warfare: Such products do not fall within the scope of the IVDR because they are bit intended to be used on human specimens.
Tests to be used in law enforcement: The IVDR does not apply to tests used exclusively in law enforcement or for other nonmedical purposes.
Relation with biocidal products Regulation: Product falling within the scope of the IVDR are excluded from Regulation 528/2012 on biocidal products. However, if a biocidal product falls within the scope of the IVDR, the IVDR applies to cover aspects not covered by the biocidal products Regulation.
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