RESUMO
BACKGROUND: Innovative high-risk medical devices, such as new types of heart valves or hip prostheses, become available on the European market more rapidly than in USA. This is due to the European legislation allowing early marketing of innovative high-risk medical devices before high-quality clinical evidence is obtained from randomized controlled trials. METHODS: We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the USA. We also discussed patient safety and the transparency of information. The literature and regulatory documents were checked. Representatives from industry, competent authorities, notified bodies, ethics committees, and health technology assessment agencies were consulted. RESULTS: In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. For the patient, this implies earlier access to innovative technology, but at the risk of potential safety issues. At this moment, European requirements for clinical studies are lower for medical devices than for drugs, and data from premarket clinical trials are scarce or remain unpublished. The European Medical Device Directives are currently being reworked. CONCLUSIONS: For innovative high-risk devices, and while awaiting a reworked Medical Device Directive, patient risk should be minimized by limiting the market introduction of novel high-risk devices with minimal clinical data to physicians with the necessary training and expertise. The new European legislation should require the premarket demonstration of clinical efficacy and safety, using a randomized controlled trial if possible, and a transparent clinical review, preferably centralized.