Under the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746), Class A is the lowest risk class. Rule 5 of Annex VIII lists three groups of products that are Class A. This article explains them with examples and shows how classification works when several IVD components are used together.
Group 1: general laboratory products, accessories, buffers and washing solutions
This group covers products for general laboratory use, accessories without critical characteristics, buffer solutions, washing solutions, and general culture media and histological stains, intended by the manufacturer to make them suitable for in vitro diagnostic procedures relating to a specific examination.
- If the manufacturer specifically designs such a product for an IVD examination, it is a Class A device.
- An accessory for an IVD is an article which, while not itself an IVD, is intended by its manufacturer to be used together with one or more particular IVDs to enable them to be used in accordance with their intended purpose, or to specifically and directly assist their medical functionality.
Examples: general microbiological culture media containing specific reagents, inhibitors or chromogenic indicators; solutions such as detergents, buffers, lysis solutions and diluents used with IVDs; pipettes with a fixed volume dedicated to a specific IVD test on human samples (for example coagulation pipettes with automatic timing as an accessory to a coagulometer); general stains such as haematoxylin, eosin, Papanicolaou and Gram iodine; kits for the extraction and purification of nucleic acids from human specimens; library preparation reagents for NGS; nucleic acid quantification kits; general, non-assay-specific reagents used with Class A instruments, such as generic sequencing consumables.
Group 2: instruments intended by the manufacturer for IVD procedures
Instruments and reagents depend on each other, and the performance of a reagent on an instrument is part of the reagent’s conformity assessment. If an instrument has an independent measuring function and works without additional reagents, it is classified according to the intended purpose of the analysis (including instrument calibrators and controls) – examples are cell counters used in haematology, ion-selective electrodes, instruments measuring blood gases or glucose via sensors, specific gravity measurement in urinalysis, mass spectrometers for bacterial identification or erythrocyte sedimentation rate analysers.
Typical Class A instruments: enzyme immunoassay analysers, PCR thermal cyclers, NGS sequencers, clinical chemistry analysers, automated nucleic acid extraction instruments and PCR devices.
Group 3: specimen receptacles
Empty specimen containers, or containers prefilled with fixatives or other general reagents, as well as evacuated or non-evacuated tubes intended for the conditioning, stimulation, transport, storage and collection of biological specimens (cells, tissue, urine, stool) for in vitro diagnostic examination.
Products used in combination
Example 1: ELISA assay and analyser. The classification depends on the intended purpose of each component. An analyser used only to run and read the ELISA, together with its driving software, is Class A. The reagents used with it to determine one or more markers are classified on their own merits – Class B, C or D depending on their intended purpose. Calibrators fall into the same class as the reagent they calibrate. Buffers and washing solutions without critical characteristics are Class A.
Example 2: blood gas analyser and its consumables (for illustration only; other classifications may apply depending on intended purpose):
- The analyser and its software are Class B if it measures parameters directly from the specimen without reagents or single-use cartridges and an erroneous result would not lead to patient management decisions resulting in a life-threatening situation. It is Class A if it cannot measure parameters itself and only analyses specimens using replaceable sensor cartridges or reagents.
- Sensor cartridges/reagents are Class C if they determine at least one parameter where an erroneous result could lead to life-threatening patient management decisions, and Class B if they do not determine such a parameter.
- Solution packs are Class C if they have critical characteristics and contain reagents used for analyte determination where an erroneous result could lead to life-threatening decisions, and Class A if they have no critical characteristics and contain no reagents used for analyte determination.
Conclusion
A Class A IVD may belong to one of the three groups above or be a Class A component of a system used in combination. If a system is placed on the market as a whole, it is classified according to its highest-risk component; a component that is itself Class A and placed on the market separately follows the Class A route.
How EVERBIZ can help
EVERBIZ supports IVD manufacturers with IVDR classification, technical documentation, performance evaluation and EU authorised representation. Contact us for a classification check.
This article is for general information only and does not constitute legal advice. The IVDR and MDCG 2020-16 are authoritative.