The term ‘in vitro diagnostic medical devices (IVDs)’ refers to medical devices used for the laboratory analysis of samples taken from the human body. The analysis takes place outside the body (Latin ‘in vitro’, meaning ‘in glass’), with the aim of establishing a diagnosis.
Article 2(1) of the IVDR defines in vitro diagnostic medical devices as follows:
“‘In vitro diagnostic medical device’ means a medical device intended, as a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, device, software or system — either alone or in combination — intended by the manufacturer for the in vitro examination of specimens derived from the human body, including blood and tissue donations, and is intended exclusively or principally to provide information on one or more of the following
- on physiological or pathological processes or conditions,
- on congenital physical or mental impairments,
- on predisposition to a specific health condition or disease,
- to determine safety and tolerability in potential recipients,
- on the expected effect of a treatment or the expected reactions to it, or
- to determine or monitor therapeutic measures.
Sample containers are also considered to be in vitro diagnostic medical devices;
Examples of IVDs include self-test kits such as rapid COVID-19 tests or pregnancy tests, as well as laboratory tests such as genetic cancer tests or HIV diagnostic tests.
Since May 2022, EU Regulation 2017/746 (IVDR) has governed the legal framework for IVDs, i.e. the requirements, definitions and authorisation. This EU Regulation replaced the previously applying EU Directive 98/79/EC (IVDD). As a regulation carries greater legal weight than a directive, this has, on the one hand, harmonised European requirements; on the other hand, it has also imposed stricter regulatory requirements on some manufacturers.
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