• Frank Hulstaert, Mattias Neyt, Imgard Vinck, Sabine Stordeur, Mirjana Huić, Stefan Sauerland, Marja R Kuijpers, Payam Abrishami, Hindrik Vondeling, Bruno Flamion, Silvio Garattini, Mira Pavlovic, and Hans van Brabandt.
• Belgian Health Care Knowledge Center (KCE), Brussels, Belgium. frank.hulstaert@kce.fgov.be
• Int J Technol Assess Health Care. 2012 Jul 1; 28 (3): 278-84.

ObjectivesHigh-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate.MethodsThe literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information.ResultsIn contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus have earlier access to a potentially lifesaving device, but at the risk of insufficiently documented efficacy and safety. Variations in the stringency of clinical reviews, both at the level of Notified Bodies and Competent Authorities, do not guarantee patient safety. We tried to document the design of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials.ConclusionsFor innovative high-risk devices, new EU legislation should require the premarket demonstration of clinical efficacy and safety, using an RCT if possible, and a transparent clinical review, preferably centralized.

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