New European Regulation for Medical Devices: What Is Changing?-Reference-Cited by-同舟云学术

New European Regulation for Medical Devices: What Is Changing?

Published:2019-05-23 Issue:9 Volume:42 Page:1272-1278
ISSN:0174-1551
Container-title:CardioVascular and Interventional Radiology
language:en
Short-container-title:Cardiovasc Intervent Radiol

Author:

Martelli Nicolas^ORCID,Eskenazy Déborah,Déan Carole,Pineau Judith,Prognon Patrice,Chatellier Gilles,Sapoval Marc,Pellerin Olivier

Publisher

Springer Science and Business Media LLC

Subject

Cardiology and Cardiovascular Medicine,Radiology, Nuclear Medicine and imaging

Link

http://link.springer.com/content/pdf/10.1007/s00270-019-02247-0.pdf

Reference11 articles.

1. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Official Journal of The European Communities L 169, 12.7.1993; 1–43. n.d. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A31993L0042 Accessed 21 Oct 2018.

2. Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. vol. OJ L. 1990.

3. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. vol. OJ L. 1998.

4. French-Mowat E, Burnett J. How are medical devices regulated in the European Union? J R Soc Med. 2012;105:S22–S28. https://doi.org/10.1258/jrsm.2012.120036 .

5. 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. vol. 117. 2017.

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