In Vitro Diagnostic

Scope of Directive

The In Vitro Diagnostic Medical Directive (IVDD) 98/79/EC published in October 1998 will become mandatory in December 2003 for all in vitro diagnostic medical devices not covered by the MDD or the AIMDD.

This directive divides in vitro diagnostic medical devices into 5 product groups, depending on their intended use and the risks involved:

1. Devices for self-testing by lay persons in a home environment.

2. In Annex II List A-reagents and reagent products, including calibrators and control materials for determining particular blood groups (ABO, Rhesus, anti-Kell) and for the detection of HIV, HTLV or Hepatitis B, C and D.

3. In Annex II List B-reagents and reagent products, including calibrators and control materials:

· For determining the blood groups anti-Duffy and anti-Kidd,
· For determining irregular anti-erythrocytic antibodies
· For diagnosing the hereditary disease phenylketonuria
· For detecting rubella or toxoplasmosis
· For determining cytomegalovirus and chlamydia
· For determining the HLA tissue groups; DR, A, B
· For determining the tumoral marker PSA
· For evaluating the risk of trisomy 21
· Products for self-diagnosis: device for measurement of blood sugar.

4. Devices for purposes of performance evaluation, which are intended to be subjected to performance evaluation studies outside the manufacturer's own premises.

5. Other in-vitro diagnostic medical devices: Devices not listed in Annex II and which are not intended for self-testing or for purposes of performance evaluation.

The "Essential Requirements" of the IVDD shall be supported by test reports based on harmonized standards (ENs). The use of harmonized standards presumes compliance with the Essential Requirements (Annex I). The tests can be completed by a first, second or third-party organization, which would be affiliated with a Notified Body.

In-Vitro-Diagnostic (IVD)

European directive 98/79/EC on in vitro diagnostics Building of the technical documentation Proven steps on the way to CE marking

 

 

Medical Devices

Medical devices (active/non-active) Processing of medical products In-Vitro-Diagnostic (IVD) Active implantable medical devices International Approvals for medical devices