Conformity assessment routes and the role of the Notified Body

The IVD Directive 98/79/EC indicates different routes for manufacturers  to comply with the requirements  indicated in the IVD Directive 98/79/EC and applicable standards. The different conformity routes, as described in the New Approach Directive, are dependent on the classification of the device and therefore are linked to the perceived risk of that product.

For higher risk devices (mentioned in List A, List B and devices for Self-Testing) the manufacturer must gain independent certification by a Notified Body in order to complete the conformity route process, apply for CE Marking and be able to place the device on the European market.

For the very highest risk devices in List A, there are additional requirements to address this high risk. Each List A device must undergo a detailed review of the technical documentation called the EC Design Examination.

Example of List A Devices are reagent and reagent products, including calibrators and control materials for:

Determining blood groups
• Rhesus (C, c, D, E, e)
• Anti Kell “

The detection, confirmation and quantification
• HIV 1 and 2
• HTLV I and II
• Hepatitis B, C and D