Lifecycle evidence requirements for high-risk implantable medical devices: a European perspective-Reference-Cited by-同舟云学术

Lifecycle evidence requirements for high-risk implantable medical devices: a European perspective

Published:2020-10-02 Issue:10 Volume:17 Page:993-1006
ISSN:1743-4440
Container-title:Expert Review of Medical Devices
language:en
Short-container-title:Expert Review of Medical Devices

Author:

Tarricone Rosanna¹²³^ORCID,Ciani Oriana³⁴^ORCID,Torbica Aleksandra¹²^ORCID,Brouwer Werner⁵^ORCID,Chaloutsos Georges⁶,Drummond Michael F⁷^ORCID,Martelli Nicolas⁸^ORCID,Persson Ulf⁹,Leidl Reiner¹⁰,Levin Les¹¹,Sampietro-Colom Laura¹²,Taylor Rod S¹³^ORCID

Affiliation:

1. Department of Social and Political Science, Bocconi University, Milan, Italy

2. SDA Bocconi School of Management, Milan, Italy

3. SDA Bocconi School of Management, Centre for Research on Health and Social Care Management (CERGAS), Milan, Italy

4. Institute of College and Medicine, University of Exeter, South Cloisters, St Luke’s Campus, Exeter, UK

5. Erasmus School of Health Policy & Management (ESHPM), Erasmus University Rotterdam, Rotterdam, PA, The Netherlands

6. Biomedical Engineering Department, Onassis Cardiac Surgery Centre & Director, Athens, Greece

7. Professor of Health Economics, Centre for Health Economics, University of York, York, UK

8. Associate Clinical Professor, Hôpital Européen Georges Pompidou, Paris, France

9. IHE, Swedish Institute for Health Economics, Lund, Sweden

10. Institute of Health Economics and Healthcare Management, Helmholtz Zentrum München - German Research Center for Environmental Health (Gmbh), Neuherberg, Germany

11. Chief Executive Officer & Scientific Officer, EXCITE International, Canada

12. Deputy Director of Innovation, Head of Health Technology Assessment Unit at Hospital Clinic Barcelona, Spain

13. Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK

Funder

Evidence Council

Publisher

Informa UK Limited

Subject

Biomedical Engineering,General Medicine,Surgery

Link

https://www.tandfonline.com/doi/pdf/10.1080/17434440.2020.1825074

Reference84 articles.

1. European Union. 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. May 5, 2017.

2. European Union. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. May 5, 2017.

3. European Commission. Proposal for a regulation of the European parliament and of the council on health technology assessment and amending directive 2011/24/EU. Jan 31, 2018

4. European Union. Regulation (EU) 2020/561 of the European parliament and of the council of 23 april 2020 amending regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions . 2020 Apr 24[cited 2020 Jun 30]. Available from: https://eur-lex.europa.eu/eli/reg/2020/561/oj.

5. The rise of rules: Will the new EU regulation of medical devices make us safer?

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