Match!

PRE-MARKET CLINICAL EVALUATIONS OF INNOVATIVE HIGH-RISK MEDICAL DEVICES IN EUROPE

Published on Jul 1, 2012in International Journal of Technology Assessment in Health Care1.42
· DOI :10.1017/S0266462312000335
Frank Hulstaert22
Estimated H-index: 22
,
Mattias Neyt17
Estimated H-index: 17
+ 10 AuthorsHans Van Brabandt12
Estimated H-index: 12
Abstract
Objectives: High-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. Methods: The 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. 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. 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. Conclusions: For 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.
  • References (20)
  • Citations (31)
References20
Newest
#1Marc I. Chimowitz (MUSC: Medical University of South Carolina)H-Index: 43
#2Michael J. Lynn (Emory University)H-Index: 54
Last.Michael F. Waters (UF: University of Florida)H-Index: 17
view all 25 authors...
#1M Thompson (OHSU: Oregon Health & Science University)H-Index: 8
#2Carl Heneghan (University of Oxford)H-Index: 47
Last.Deborah CohenH-Index: 18
view all 4 authors...
#1Alan Gordon Fraser (Cardiff University)H-Index: 39
#2Mitchell W. Krucoff (Duke University)H-Index: 59
Last.Sidney C. Smith Mdfacc (UNC: University of North Carolina at Chapel Hill)H-Index: 165
view all 5 authors...
Cited By31
Newest
#1Bruce CampbellH-Index: 2
#2John WilkinsonH-Index: 1
Last.Murray SheldonH-Index: 2
view all 4 authors...
#1Ivo S. Muskens (Brigham and Women's Hospital)H-Index: 6
#2Saksham Gupta (Brigham and Women's Hospital)H-Index: 4
Last.Marike L. D. Broekman (Brigham and Women's Hospital)H-Index: 7
view all 5 authors...
#1Alan G Fraser (Katholieke Universiteit Leuven)H-Index: 3
#2Eric G. Butchart Frcs Fetcs Fesc (University Hospital of Wales)H-Index: 28
Last.Frans Van de Werf (Katholieke Universiteit Leuven)H-Index: 4
view all 7 authors...
#1Britta Olberg (Technical University of Berlin)H-Index: 3
#2Sabine Fuchs (Technical University of Berlin)H-Index: 5
Last.Reinhard Busse (Technical University of Berlin)H-Index: 43
view all 5 authors...
View next paperRegulation of Medical Devices in the United States and European Union