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First: 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 certifications by Notified BodyOR
Registration File AND ISO 9002 / ISO 13485 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
certification by Notified Body OR
Registration File AND ISO 9002 / ISO 13485 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 9002 / ISO 13485 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 |
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