On the new regulation of medical devices in Europe-Reference-Cited by-同舟云学术

On the new regulation of medical devices in Europe

Published:2017-11-24 Issue:12 Volume:14 Page:921-923
ISSN:1743-4440
Container-title:Expert Review of Medical Devices
language:en
Short-container-title:Expert Review of Medical Devices

Author:

Migliore Antonio¹

Affiliation:

1. Innovation and Development Department, Agenas, Agenzia nazionale per i servizi sanitari regionali, Rome, Italy

Publisher

Informa UK Limited

Subject

Biomedical Engineering,General Medicine,Surgery

Link

https://www.tandfonline.com/doi/pdf/10.1080/17434440.2017.1407648

Reference6 articles.

1. Commentary: Europe needs a central, transparent, and evidence based regulation process for devices

2. 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

3. European Parliament. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Off J Europ Uni. L 117;5 May 2017. Available from: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745

4. Introduction of high-risk medical devices: national measures that can be taken under the current European legislation to put the patient interest central

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