title: [Introduction of innovative high-risk medical devices in Europe: are clinical efficacy and safety guaranteed?].
abstract: 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studies are lower for medical devices than for drugs, and data from premarket clinical trials are scarce or remain unpublished.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.
authors.affiliation: Centre fédéral d'expertise des soins de santé/Belgian health care knowledge centre, boulevard du Botanique 55, 1000 Brussels, Belgium. sabine.stordeur@kce.fgov.be
authors.forename: S
authors.initials: S
authors.lastname: Stordeur
authors.forename: I
authors.initials: I
authors.lastname: Vinck
authors.forename: M
authors.initials: M
authors.lastname: Neyt
authors.forename: H
authors.initials: H
authors.lastname: Van Brabandt
authors.forename: F
authors.initials: F
authors.lastname: Hulstaert
mesh_terms: D020811:Biomedical Technology / Q000295:instrumentation; D002986:Clinical Trials as Topic; D054626:Consumer Health Information; D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D005062:European Union; D033161:Government Regulation; D006801:Humans; D008389:Marketing of Health Services; D062307:Medical Device Legislation; D061214:Patient Safety; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D016896:Treatment Outcome; D014481:United States