Clinical studies of innovative medical devices: what level of evidence for hospital-based health technology assessment?

Author:

Boudard Aurélie1,Martelli Nicolas1,Prognon Patrice1,Pineau Judith1

Affiliation:

1. Pharmacy Department; Georges Pompidou European Hospital; AP-HP; Paris France

Publisher

Wiley

Subject

Public Health, Environmental and Occupational Health,Health Policy

Reference28 articles.

1. European Council 2007 Directive 2007/47/EC of the European Parliament and of the Council . http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:247:0021:0055:en:PDF

2. Europeans are left to their own devices;Cohen;British Medical Journal,2011

3. European Commission MEDDEV 2.7/4 December 2010. Guidelines on medical devices. Clinical evaluation: a guide for manufacturers and notified bodies http://ec.europa.eu/health/medical-devices/files/meddev/2_7_4_en.pdf

4. Pre-market clinical evaluations of innovative high-risk medical devices in Europe;Hulstaert;International Journal of Technology Assessment in Health Care,2012

5. The development of health technology assessment;Banta;Health Policy,2003

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