In Vitro Diagnostic Devices means :
“any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.”
The directive applies different administrative requirements to devices depending on the risk which they present to the user.
There are four classifications:
- General devices
- Self test devices not listed in Annex II of the IVDD
- Devices listed in Annex II List A
- Devices listed in Annex II List B
Annex II Listed devices:
A: Reagents and reagent products, including related calibrators and control materials for:
- determining the blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell,
- the detection, confirmation and quantification in human specimens of markers of: HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D.
B: Reagents and reagent products, including related calibrators and control materials for:
- determining the blood groups: anti-Duffy and anti-Kidd,
- determining irregular anti-erythrocytic antibodies,
- the detection and quantification in human samples of the congenital infections: rubella, toxoplasmosis,
- diagnosing the hereditary disease: phenyloketonuria,
- determining the human infections: cytomegalovirus and chlamydia,
- determining the HLA tissue groups: DR, A, B,
- determining the tumoral marker: PSA,
- evaluating the risk of trisomy 21 (specifically designed and including software), and devices for:
- measurement of blood sugar for self-diagnosis, including its related calibrators and control materials.