Classification

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The new Directive divides in vitro diagnostic medical devices into 5 product groups, depending on their intended use and the risks involved:

1. Devices for self-testing by lay persons in a home environment.
2. In Annex II List A the list of reagents and reagent products, including calibrators and control materials for determining particular blood groups (ABO, Rhesus, anti-Kell) and for the detection of HIV, HTLV or Hepatitis B, C and D.
3. In Annex II List B the list of reagents and reagent products, including calibrators and control materials
   • for determining the blood groups anti-Duffy and anti-Kidd,
   • for determining irregular anti-erythrocytic antibodies
   • for diagnosing the hereditary disease phenylketonuria
   • for detecting rubella or toxoplasmosis
   • for determining cytomegalovirus and chlamydia
   • for determining the HLA tissue groups: DR, A, B
   • for determining the tumoral marker PSA
   • for evaluating the risk of trisomy 21
   • products for self-diagnosis: device for the measurement of blood sugar.
4. Devices for purposes of performance evaluation, which are intended to be subjected to performance evaluation studies outside the manufacturer's own premises
5. Other in-vitro diagnostic medical devices: Devices not listed in Annex II and which are not intended for self-testing or for purposes of performance evaluation.