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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