The main medical device directives that apply to clinical investigations of medical devices are: the Medical Device Directive (MDD), the Active Implantable Medical Device Directive (AIMDD), the Medicinal Product Directive (MPD) and the In Vitro diagnostic Directive. All directives have been implemented to Finnish law accordingly. Clinical evaluation is required to determine the clinical safety and performance of medical device and constitute part of the procedure to demonstrate conformity with the essential requirements of the directive prior to placing the device on the market or putting it into service.
The clinical evaluation is based on a comprehensive analysis of available pre- and post market clinical data relevant to the intended use of the device in question, including clinical performance and safety data. Typically clinical data is sourced from a critical evaluation of the clinical trials or other studies reported in relevant scientific literature where there is a demonstration of equivalence.
Clinical investigation shall be undertaken only when necessary data concerning the performance, safety and clinical benefit can’t be obtained by above mentioned means. High risk devices, those based on technologies where there is little or no experience, and those that extend the intended purpose of an existing technology (i.e. a new clinical use) are most likely to require clinical investigation data. MEDDEV 2.7.1 provides detailed guidance on the clinical evaluation process. The requirements concerning clinical investigations are contained in national legislation. More information will be found in Valvira or European Comission websites.