Glossary · EU in vitro diagnostics: IVDR
In vitro diagnostic medical device (IVD)
Also known as: IVD, In vitro diagnostic device, IVD medical device
Under the EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, an in vitro diagnostic medical device is any medical device that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system intended by the manufacturer to be used in vitro to examine specimens derived from the human body, solely or principally to provide information on a physiological or pathological state, congenital impairments, predisposition, safety and compatibility with potential recipients, treatment response, or to define or monitor therapeutic measures. Specimen receptacles are also IVDs.
- EU
- IVDR
In one sentence
An IVD under IVDR Article 2(2) is a device used in vitro to examine human specimens and provide diagnostic, predictive or monitoring information.
Example
A blood glucose test strip, the meter that reads it and the app that interprets the readings for insulin dosing are each in vitro diagnostic medical devices when the manufacturer intends them for that purpose.
How it applies
- Intended purpose decides: A reagent becomes an IVD through the manufacturer’s intended use statement, not through its chemistry. The same antibody can be a research reagent or an IVD component.
- Forms: Laboratory assays, analyzers, self-tests for lay persons, near-patient tests and software that interprets results. Software that processes IVD data for a medical purpose is medical device software regulated under the IVDR.
- Not IVDs: Products for general laboratory use and research-use-only products are not IVDs unless the manufacturer intends them specifically for in vitro diagnostic examination.
- Specimen receptacles: Containers intended specifically for the primary containment and preservation of specimens are IVDs, even though they perform no examination.
- Technical documentation: The intended purpose statement in the technical documentation, label and IFU drives classification and evidence. It names what is detected or measured, its function (screening, diagnosis, monitoring), the specimen type, the user and the target population.
IVD vs. medical device under the MDR
In EU law an IVD is a kind of medical device, which is why it sits under the MDR definition in this glossary, but it is regulated by the IVDR, not the MDR. The test is whether the device examines specimens outside the body. See Medical device vs. IVD: MDR vs. IVDR.