E. Commission and . Growth, Internal Market, Industry, Entrepreneurship and SMEs; Medical Devices/growth/sectors/ medical-devices, 2016.

H. Marcus, C. Payne, A. Hughes-hallett, A. Marcus, G. Yang et al., Regulatory approval of new medical devices: cross sectional study, BMJ, vol.353, p.2587, 2016.
DOI : 10.1136/bmj.i2587

M. Eikermann, C. Gluud, M. Perleth, C. Wild, S. Sauerland et al., Commentary: Europe needs a central, transparent, and evidence based regulation process for devices, BMJ, vol.346, issue.may07 3, p.2771, 2013.
DOI : 10.1136/bmj.f2771

S. Weber and A. Haverich, Pioneering surgical innovations in Germany, Der Chirurg, vol.109, issue.1, pp.423-455, 2016.
DOI : 10.1016/j.zefq.2015.05.016

S. Garattini, J. Jakobsen, J. Wetterslev, V. Bertele, R. Banzi et al., Evidence-based clinical practice: Overview of threats to the validity of evidence and how to minimise them, European Journal of Internal Medicine, vol.32, pp.13-21, 2016.
DOI : 10.1016/j.ejim.2016.03.020

S. Djurisic, A. Rath, S. Ngwabyt, E. Neugebauer, M. Laville et al., Barriers to the conduct of randomised clinical trials within all disease areas, Trials, vol.497, issue.7451, p.360, 2017.
DOI : 10.1038/497557a
URL : https://hal.archives-ouvertes.fr/inserm-01572262

A. Rath, V. Salamon, S. Peixoto, V. Hivert, M. Laville et al., A systematic literature review of evidence-based clinical practice for rare diseases: what are the perceived and real barriers for improving the evidence and how can they be overcome? Trials

M. Laville, B. Segrestin, Y. Masson, C. Ruano-rodríguez, L. Serra-majem et al., Evidence-based practice within nutrition: what are the barriers for improving the evidence and how can they be dealt with?, Trials, vol.11, issue.10, p.425, 2017.
DOI : 10.1007/s11306-014-0750-y
URL : https://hal.archives-ouvertes.fr/inserm-01588782

K. Mazor, J. Sabin, D. Boudreau, M. Goodman, J. Gurwitz et al., Cluster Randomized Trials, Medical Care, vol.45, issue.Suppl 2, pp.29-37, 2007.
DOI : 10.1097/MLR.0b013e31806728c4

A. Bernard, M. Vaneau, I. Fournel, H. Galmiche, P. Nony et al., Methodological choices for the clinical development of medical devices, Medical Devices: Evidence and Research, vol.7, pp.325-359, 2014.
DOI : 10.2147/MDER.S63869

P. Devereaux, M. Bhandari, M. Clarke, V. Montori, D. Cook et al., Need for expertise based randomised controlled trials, BMJ, vol.330, issue.7482, p.88, 2005.
DOI : 10.1136/bmj.330.7482.88

E. Neugebauer, M. Becker, G. Buess, A. Cuschieri, H. Dauben et al., EAES recommendations on methodology of innovation management in endoscopic surgery, Surgical Endoscopy, vol.146, issue.Suppl 6, pp.1594-615, 2010.
DOI : 10.7326/0003-4819-146-9-200705010-00155

N. Heart, B. Lung, . Institute, and . Dr, Michael Lauer Co-Publishes Perspective Piece on Randomized Registry Trials. 2013. http://www.nhlbi.nih. gov/news/spotlight/fact-sheet/dr-michael-lauer-co-publishes-perspectivepiece-randomized-registry-trials, 2016.

P. Mcculloch, J. Cook, D. Altman, C. Heneghan, and M. Diener, IDEAL framework for surgical innovation 1: the idea and development stages, BMJ, vol.346, issue.jun18 3, p.3012, 2013.
DOI : 10.1136/bmj.f3012

A. Sedrakyan, B. Campbell, J. Merino, R. Kuntz, A. Hirst et al., IDEAL-D: a rational framework for evaluating and regulating the use of medical devices Conventional versus laparoscopic cholecystectomy and the randomized controlled trial. Cholecystectomy Study Group, BMJ. Br J Surg, vol.35378, issue.2, pp.150-154, 1991.

A. Majeed, G. Troy, J. Nicholl, A. Smythe, M. Reed et al., Randomised, prospective, single-blind comparison of laparoscopic versus small-incision cholecystectomy, The Lancet, vol.347, issue.9007, pp.989-94, 1996.
DOI : 10.1016/S0140-6736(96)90143-9

F. Keus, H. Gooszen, and C. Van-laarhoven, Open, small-incision, or laparoscopic cholecystectomy for patients with symptomatic cholecystolithiasis. An overview of Cochrane Hepato-Biliary Group reviews, Cochrane Database Syst Rev, vol.336, issue.7644, p.8318, 2010.
DOI : 10.1001/archsurg.134.3.308

J. Jakobsen and C. Gluud, The Necessity of Randomized Clinical Trials, British Journal of Medicine and Medical Research, vol.3, issue.4, pp.453-1468, 2013.
DOI : 10.9734/BJMMR/2013/3208

T. Chalmers, Randomize the first patient, N Engl J Med, vol.296, issue.2, p.107, 1977.

M. Wente and . Hurden-bei-studien-mit-medizinprodukten, H??rden bei Studien mit Medizinprodukten, Zeitschrift f??r Evidenz, Fortbildung und Qualit??t im Gesundheitswesen, vol.106, issue.5, pp.315-324, 2012.
DOI : 10.1016/j.zefq.2012.05.002

E. Bednarska, D. Bryant, and P. Devereaux, Orthopaedic Surgeons Prefer to Participate in Expertise-based Randomized Trials, Clinical Orthopaedics and Related Research, vol.78, issue.7, pp.1734-1778, 2008.
DOI : 10.1056/NEJM198707163170304

M. Campbell, R. Fitzpatrick, A. Haines, A. Kinmonth, P. Sandercock et al., Framework for design and evaluation of complex interventions to improve health, BMJ, vol.321, issue.7262, pp.694-700, 2000.
DOI : 10.1136/bmj.321.7262.694

I. Boutron, D. Moher, P. Tugwell, B. Giraudeau, S. Poiraudeau et al., A checklist to evaluate a report of a nonpharmacological trial (CLEAR NPT) was developed using consensus, Journal of Clinical Epidemiology, vol.58, issue.12, pp.1233-1273, 2005.
DOI : 10.1016/j.jclinepi.2005.05.004

L. Kjaergard, J. Villumsen, and C. Gluud, Reported Methodologic Quality and Discrepancies between Large and Small Randomized Trials in Meta-Analyses, Annals of Internal Medicine, vol.135, issue.11
DOI : 10.7326/0003-4819-135-11-200112040-00010

L. Gluud, K. Thorlund, C. Gluud, L. Woods, R. Harris et al., Correction: Reported Methodologic Quality and Discrepancies between Large and Small Randomized Trials in Meta-Analyses, Annals of Internal Medicine, vol.149, issue.3, p.219, 2008.
DOI : 10.7326/0003-4819-149-3-200808050-00023

L. Wood, M. Egger, L. Gluud, K. Schulz, P. Juni et al., Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study, BMJ, vol.336, issue.7644, pp.601-606, 2008.
DOI : 10.1136/bmj.39465.451748.AD

J. Savovic, H. Jones, D. Altman, R. Harris, P. Juni et al., Influence of Reported Study Design Characteristics on Intervention Effect Estimates From Randomized, Controlled Trials, Annals of Internal Medicine, vol.157, issue.6, pp.429-467, 2012.
DOI : 10.7326/0003-4819-157-6-201209180-00537

T. Jarvinen, R. Sihvonen, M. Bhandari, S. Sprague, A. Malmivaara et al., Blinded interpretation of study results can feasibly and effectively diminish interpretation bias, Journal of Clinical Epidemiology, vol.67, issue.7, pp.769-72, 2014.
DOI : 10.1016/j.jclinepi.2013.11.011

P. Gotzsche, Blinding during data analysis and writing of manuscripts, Controlled Clinical Trials, vol.17, issue.4, pp.285-90, 1996.
DOI : 10.1016/0197-2456(95)00263-4

J. Higgins and S. Green, The Cochrane Handbook for Systematic Reviews of Interventions, 2011.
DOI : 10.1002/9780470712184

S. Shah and I. Robinson, Benefits of and barriers to involving users in medical device technology development and evaluation, International Journal of Technology Assessment in Health Care, vol.3, issue.01, pp.131-138, 2007.
DOI : 10.1111/1540-5885.340276

P. Tekkis, A. Senagore, C. Delaney, and V. Fazio, Evaluation of the Learning Curve in Laparoscopic Colorectal Surgery, Annals of Surgery, vol.242, issue.1, pp.83-91, 2005.
DOI : 10.1097/01.sla.0000167857.14690.68

P. Probst, P. Knebel, K. Grummich, S. Tenckhoff, A. Ulrich et al., Industry Bias in Randomized Controlled Trials in General and Abdominal Surgery, Annals of Surgery, vol.264, issue.1, pp.87-92, 2016.
DOI : 10.1097/SLA.0000000000001372

A. Lundh, J. Lexchin, B. Mintzes, J. Schroll, and L. Bero, Industry sponsorship and research outcome, Cochrane Database Syst Rev, vol.2, 2017.

M. Skoog, J. Saarimäki, C. Gluud, M. Sheinin, K. Erlendsson et al., Transparency and Registration in Clinical Research in the Nordic Countries, Oslo: Nordic Trial Alliance, 2015.

M. Calvert, J. Blazeby, D. Altman, D. Revicki, D. Moher et al., Reporting of Patient-Reported Outcomes in Randomized Trials, JAMA, vol.309, issue.8, pp.814-836, 2013.
DOI : 10.1001/jama.2013.879

H. Agency, . Research, and . Quality, Methods Guide for Effectiveness and Comparative Effectiveness Reviews Agency for Healthcare Research and Quality Available from: https://effectivehealthcare.ahrq.gov/topics/cer-methods-guide/overview, p.2014, 2017.

M. Siebert, L. Clauss, M. Carlisle, B. Casteels, P. De-jong et al., Health technology assessment for medical devices in Europe. What must be considered, Int J Technol Assess Health Care, vol.18, issue.3, pp.733-773, 2002.

J. Demotes-mainard and C. Kubiak, A European perspective - the European clinical research infrastructures network, Annals of Oncology, vol.22, issue.Suppl 7, pp.44-53, 2011.
DOI : 10.1093/annonc/mdr425

M. Clarke, Standardising outcomes for clinical trials and systematic reviews, Trials, vol.34, issue.2, p.39, 2007.
DOI : 10.1111/j.1523-536X.2006.00145.x

A. European-medicines, Clinical Trial Regulation, 2017.

D. Taichman, J. Backus, C. Baethge, H. Bauchner, P. De-leeuw et al., Sharing Clinical Trial Data ??? A Proposal from the International Committee of Medical Journal Editors, New England Journal of Medicine, vol.374, issue.4, pp.384-390, 2016.
DOI : 10.1056/NEJMe1515172

E. Union, Annex IX of the EU Directive 93, EEC, vol.42, 2017.

J. Meerpohl, L. Schell, D. Bassler, S. Gallus, J. Kleijnen et al., Evidence-informed recommendations to reduce dissemination bias in clinical research: conclusions from the OPEN (Overcome failure to Publish nEgative fiNdings) project based on an international consensus meeting, BMJ Open, vol.348, issue.5, p.6666, 2015.
DOI : 10.1136/bmj.g3768

J. Ioannidis, How to Make More Published Research True, PLoS Medicine, vol.51, issue.7145, p.1001747, 2014.
DOI : 10.1371/journal.pmed.1001747.t002

B. Alberts, M. Kirschner, S. Tilghman, and H. Varmus, Rescuing US biomedical research from its systemic flaws, Proceedings of the National Academy of Sciences, vol.10, issue.3, pp.5773-5780, 2014.
DOI : 10.1187/cbe.11-02-0013

J. Ioannidis, D. Fanelli, D. Dunne, and S. Goodman, Meta-research: Evaluation and Improvement of Research Methods and Practices, PLOS Biology, vol.505, issue.7485, p.1002264, 2015.
DOI : 10.1371/journal.pbio.1002264.t002

R. Maccoun and S. Perlmutter, Blind analysis: Hide results to seek the truth, Nature, vol.526, issue.7572, pp.187-196, 2015.
DOI : 10.1038/526187a