Just before the holidays the Commission has issued guidelines on an issue that suffers a lot from the lack of harmonisation in the EU: clinical investigation for medical devices. Now that the medical devices directives as amended by directive 2007/47 (effective as of 21 March 2010) require more focus on the substantiation of clinical evaluation with actual clinical data produced in a clinical investigation.
- MEDDEV 2.7/3 (CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC) and
- MEDDEV 2.7/4 (GUIDELINES ON CLINICAL INVESTIGATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES)
are contained in two documents which both address the clinical investigation referred to in Annex 7 of the Active Implantable Medical Devices Directive and Annex X of the Medical Devices Directive and are part of the European Commission’s efforts to provide for more harmonisation in this area, because the directives themselves do not give any guidance on how to perform a clinical investigation. A known problem is for example that the national competent authorities have different views about SAE reporting, for which MEDDEV 2.7/3 now provides guidance. MEDDEV 2.7/4 provides guidance for manufacturers and notified bodies on when clinical investigation is necessary and how a clinical investigation should be designed and performed.
A good overview of these and other issues in a wider context is provided in a number of presentations on clinical investigation from the recent Eucomed MedTech Forum. Obviously, as clinical trials have an ever more international dimension, it becomes more and more important that the rules are harmonised in the EU. For lack of a clinical trial directive such as we have for medicinal products, the Commission undertakes informal harmonisation through MEDDEV documents that are drafted in close consultation with industry and competent authorities. This is another step that seeks to improve legal certainty for all parties involved.