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Product Line Assessment

In the IVD Directive (Council Directive 98/79/EC), IVD products are classified to the extent that the diagnostic is relied upon for life. For example, diagnostics which are used to detect presence of HIV or hepatitis virus are relied upon to detect life-threatening conditions. Therefore these are regulated in a higher class.

Product Groups	IVDD Reference	Conformity Routes
HIV 1 HIV 2 HTLV I, HTLV II Hepatitis B,C,D ABO, Rh, Anti-Keil Blood typing	Annex II, A List	Design Dossier AND ISO 9001 / ISO 13485 Full Quality Assurance System Certification by Notified Body OR Registration File AND ISO 9001 / ISO 13485 Production Quality Assurance certification by Notified Body
Anti-Duffy Anti-Kidd Blood Glucose Self Tests Chlamydia Cytomegalovirus HLA tissue groups (DR, A,B) Irregular Antierythrocytic Antibodies Phenylketonuria Prostate specific antigen Rubella Toxoplasmosis Trisomy 21 Risk	Annex II B List	ISO 9001 / ISO 13485 Full Quality Assurance System Certification by Notified Body OR Registration File AND ISO 9001 / ISO 13485 Production Quality Assurance certification by Notified Body OR Registration File AND EC Verification by Notified Body
Self test (except blood glucose)	Article 9.1	Design Dossier OR Registration File AND ISO 9001 / ISO 13485 Production Quality Assurance certification by Notified Body OR Registration File AND EC Verification by Notified Body
IVDs for Performance Evaluation	Article 9.4	Manufacturers statement according to Annex VIII
All other products	Article 9.1	Declaration of conformity according to Annex III