The following groups are subject to different regulatory requirements to be CE-marked:
1.Products according to Annex II,List A:
Reagents and reagent products,including related calibrators and control materials,for:
- determining the following blood groups:ABO system,rhesus(C,c,D,E,e) anti-Kell
- 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.
2.Products according to Annex II,List 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,
- detection and quantification of the infections rubella and toxoplasmosis,
- determining the infections cytomegalovirus and chlamydia,
- diagnosing phenylketonuria
- determining the HLA tissue groups:DR,A,B,
- determining the tumor marker PSA,
Reagents and reagent products,including related calibrators,control materials and software for evaluating the risk of trisomy 21,
Devices for self-diagnosis including related calibrators,control materials measurement of blood suger.
3.Products for self-testing:
Devices intended to be used by a lay user in a home environment.
4.All other products:
Devices, not Listed in Annex II and not intended for self-testing.