Contrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and the USA: a systematic analysis of 10 devices based on Austrian pre-reimbursement assessments

Author:

Wild Claudia,Erdös Judit,Zechmeister Ingrid

Publisher

Springer Science and Business Media LLC

Subject

Cardiology and Cardiovascular Medicine

Reference54 articles.

1. European Commission: Revision of the medical device directives. Proposals of the European Commission. 2012, [ http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm ]

2. Fraser AG, Daubert JC, Van de Werf F, Estes NAM, Smith SC, Krucoff MW, Vardas PE, Komajda M: Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform. Report of a policy conference of the European society of cardiology. Cardiol Eur Heart J. 2011, 32 (13): 1673-1686D. 10.1093/eurheartj/ehr171.

3. Cohen D, Billingsley M: Europeans are left to their own devices. BMJ. 2011, 342: d2748-10.1136/bmj.d2748.

4. Hulstaert F, Neyt M, Vinck I, Stordeur S, Huic M, Sauerland S, Kuijpers MR, Abrishami P, Vondeling H, Flamion B, Garattini S, Pavlovic M, Van Brabandt H: Pre-market clinical evaluations of innovative high-risk medical devices in Europe. Int J TAHC. 2012, 28 (3): 278-284.

5. Cohen D: Patient groups accuse European parliament of putting economic interests ahead of safety on medical devices. BMJ. 2013, 347: f6446-10.1136/bmj.f6446.

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