Abstract

The possibilities for a rule-based classification system for in vitro diagnostic medical devices (IVDs) were explored in this report as an alternative to the system in Annex II of the European IVD Directive 98/79/EC. In a rule-based system decision-rules can classify IVDs into four risk classes (A-D) where, from a public health perspective, Class A represents IVDs with a low risk and Class D IVDs with a high risk. Derived from the Canadian model, seventeen rules have been formulated with respect to IVDs intended to detect transmissible agents and IVDs for uses other than transmissible agents. Besides this, special rules could be applied to devices for self-testing. The proposed model, which is able to classify the large majority of existing and future IVDs, offers greater flexibility than the lists in Annex II. It also fits in with the current Annex II classification, since each Annex II IVD will still be classified as high risk (class D) or moderate to high risk (class C). Moreover, other IVDs which present a more than moderate risk will be classified accordingly.