The IVD Directive and Genetic Testing: Problems and proposals

The in-vitro Medical Devices Directive (IVD Directive) sets a framework for the regulation of in-vitro diagnostic tests in the EU. Issued in 1998, the Directive came into force in 2003 in all member states. Since then, some issues have arisen with the Directive which have particular relevance for genetic testing.

The in-vitro Medical Devices Directive (IVD Directive) sets a framework for the regulation of in-vitro diagnostic tests in the EU. Issued in 1998, the Directive came into force in 2003 in all member states. Since then, some issues have arisen with the Directive which have particular relevance for genetic testing. In this document, Stuart Hogarth and David Melzer propose an enhanced framework for the evaluation of new genetic tests before they are granted “CE marking”, the seal of approval which allows IVDs to be placed on the market in the EU.

This briefing outlines a series of issues in the IVD Directive which need to be addressed if it is to deliver the kind of systematic, independent pre-market evaluation which is proposed. Furthermore, regardless of whether there is support for the approach proposed, many of the issues raised still need to be addressed, as they are sources of ambiguity which require clarification.

Of course, some level of confusion and ambiguity is inevitable with any new piece of legislation. This seems a particularly opportune moment to consider both the issues which require clarification, and other ways in which the Directive might be enhanced: the Directive is well-established in the member states; the Commission is now contemplating a revision of the Directive; and the development of IVD regulation is being actively pursued through the work of the Global Harmonisation Task Force.

The briefing was presented to the assembled representatives of the Competent Authorities which implement the Directive in each member state at their meeting in Lisbon in June 2007. The Authorities agreed to take this document into consideration as they work on the revision of the Directive.

Summary of policy proposals

Risk classification

• EU should adopt new model developed by Global Harmonisation Task Force. This would ensure more tests are subject to pre-market review, and move EU towards its global partners, creating more consistency for manufacturers.
• However, modification is required to the GHTF model which needs to recognise that novelty is a risk factor, and that novel Class B devices require independent pre-market review. This entails modification of both the classification model and the conformity assessment model.

Analytic and clinical validity

• It should be mandatory for manufacturers to state the test’s intended clinical purpose and to provide data on both analytic and clinical validity (although for clinical validity it may be sufficient to cite the existing scientific literature).
• This could be dealt with through guidance or through revision of Essential Requirements 1 and 3. Since the Essential Requirements are in Annexe I, revisions can be made through comitology (i.e. no change to the Directive itself would be required).
• Clarifying the criteria for evaluation i not enough - manufacturers need more detailed guidance o evidence requirements – development o new standards are needed especially for highly complex tests.
< ul> < 3>In-house tests