Key Points
• As part of the In Vitro Diagnostics (IVD) sector, genetic tests fall under the broader statutory regimes for the regulation of medical devices. The EU IVD Directive governs the safety, quality and performance of devices by setting out requirements for: placing a product on the market, production, labelling, clinical evaluation/investigation and post-marketing surveillance.
• Based on the EUs New Approach legislation, the Directive sets out broad and general standards for safety and effectiveness in a series of essential requirements with which all IVDs must comply before being placed on the market.
• The regulatory controls to ensure that IVDs are compliant with the Directive are known as conformity assessment procedures. These vary depending on the risks posed by the test. Higher risk tests are subject to independent pre-market review by Notified Bodies, for low risk tests the manufacturer has sole responsibility for assessing conformity with the Directive.
• There has been a prolonged policy debate about how best to ensure the safe and appropriate use of clinical genetic tests and many believe that genetic tests should be subject to independent pre-market evaluation before entering clinical use.
• The IVD Directive, as currently implemented by member states, is considered by many to be an inadequate mechanism for ensuring the safety and effectiveness of genetic tests. In particular there is concern about a number of ambiguities and variations in interpretation and enforcement.
• Key issues which need to be addressed are classification of nearly all tests (including most genetic tests) as low risk and consequent lack of premarket review; confusion about regulatory status of laboratory-developed tests (LDTs) produced by commercial laboratories, and ambiguity about whether manufacturers must provide data on the clinical validity of their tests.
• Revision of the Directive is now being considered by the European Commission who have indicated an interest in addressing some of the issues outlined.
This chapter draws on work by Stuart Hogarth and David Melzer in collaboration with members of EuroGentest, in particular the outcomes of a EuroGentest meeting about the IVD Directive organised by David Barton in 2007, the report of that meeting written by Barton and a subsequent briefing on the Directive which Hogarth and Melzer prepared (Hogarth and Melzer 2007). This briefing was presented to the regulatory authorities of EU member states in 2007, it was then adopted as a EuroGentest report and formed the basis of a EuroGentest response to the EC consultation on the future of medical device regulation in the EU
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Hogarth, S., Barton, D., Melzer, D. (2010). The European IVD Directive and Genetic Testing. In: Kristoffersson, U., Schmidtke, J., Cassiman, J. (eds) Quality Issues in Clinical Genetic Services. Springer, Dordrecht. https://doi.org/10.1007/978-90-481-3919-4_6
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