Clinical trials involving medical devices
Clinical investigation and marketing of medical devices is regulated by series of three EU Directives, which came into force in the UK in June 2002: The Active Implantable Medical Devices Directive (which covers all powered medical devices implanted and left in the human body, such as pacemakers, implantable defibrillators, implantable infusion pumps, cochlear implants and implantable neuromuscular stimulators, it also covers external parts that are essential part of the systems.) Other Medical Devices include devices ranging from simple bandages to orthopaedic implants and high-technology radiology equipment. The In Vitro Diagnostic Medical Devices Directive (which covers any medical device, reagent, reagent product, kit, instrument, apparatus or systems which is intended to be used in-vitro for examination of substances derived from the human body, such as blood grouping reagents, pregnancy testing and Hepatitis B test kits. Any clinical research on medical device falling within these regulations has to be approved by an NHS Research Ethics Committee and registered with the MHRA (Medicines and Healthcare products Regulatory Agency). Further guidance can be obtained from the MHRA website http://www.mhra.gov.uk/index.htm
Devices undergoing clinical investigation do not need a CE mark. If the research is undertaken on behalf of a manufacturer, then the onus of responsibility for contacting regulatory bodies rests with the company itself. If the research is an in-house project, where the Trust is seen as the manufacturer, then the responsibility is with the Trust; researchers MUST notify the R&D Office as early as possible in the development of a project of this type.