The Structure of the IVD Directive 98/79/EC

The IVDD is one of the most complex of the EU’s “new approach” directives. It has 24 Articles and 10 Annexes. The Articles cover general items such as scope and definitions, placing products on the market and putting them into service, free movement of CE-marked goods in EU, reference to harmonized standards, vigilance and incident reporting, conformity assessment procedures, registration responsibilities, authorized representative, consequences of wrongly affixed CE Marking, confidentiality etc.

Annex I lists the so-called Essential Requirements. All devices must comply with these requirements (where applicable). Manufacturers are required to check each product type or model against each requirement, determine whether the requirement is applicable, acquire documented evidence of compliance and keep this evidence available in the technical file of the product. There are good reasons to say that Annex I is the real core of the whole Directive.
Annex IIlists products of high or moderate risk, and is divided into two lists:

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; the detection, confirmation and quantification in human specimens of markers of HIV 1 and 2, HTLV 1 and II and Hepatitis B, C and D.
List B: Reagents and reagent products, including related calibrators and control materials for: determining the blood groups Anti-Duffy and Anti-Kidd; determining irregular and antierythrocytic antibodies; detection and quantification of the infectious rubella and toxoplasmosis; diagnosing phenylketonuria; determining the infectious cytomegalovirus and chlamydia; HLA tissue groups DR,A,B; tumor marker PSA; evaluating the risk of trisomy 21(including software). Devices for self-diagnosis and measuremet of blood sugar (glucose).

Annex III EC Declaration of Conformity. A procedure in which the manufacturer declares to conformity of his products with the IVDD. Applicable to all devices except those listed in Annex II or devices for performance evaluation. All “ordinary” IVD products can be CE-marked using this “self-certification” route. Additionally, for devices for self-testing, a Notified Body shall carry out an examination of the design.
Annex IV Full Quality Assurance System. Applicable to all products listed in Annex II and may be applied for devices for self-testing. Sections 4 and 6 of this Annex require that design examination and batch release by a Notified Body shall be carried out for Annex II/List A products.
Annex V EC Type - examination. A procedure which involves examination and testing of representative samples of the product by Notified Body and certification that the device meets the applicable essential requirements. Annex V can only be used in combination with Annex VI (batch verification) or Annex VII (production quality assurance system approval).
Annex VI EC Verification. A procedure in which the Notified Body examines and tests every individual product or samples taken from a batch on a statistical basis.
Annex VII Production Quality Assurance. The Notified Body shall audit and certify the manufacture’s production quality system (which is usually based on EN46002 or ISO 13488 standards).
Annex VIII Devices for performance evaluation. This Annex describes procedures concerning devices for performance evaluation, i.e. devices intended by the manufacturer to be subject to performance evaluation studies in clinical laboratories or in other environments outside his own premises.
Annex IX Criteria for the designation of Notified Bodies.
Annex X Appearance of the CE-mark.