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Substantial Amendment of the EU Regulatory Framework on Medical Devices and International Trade Implications

Published online by Cambridge University Press:  20 January 2017

Ignacio Carreño
Ignacio Carreño*
Affiliation:
FratiniVergano, Brussels
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Abstract

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Type
Reports
Information
European Journal of Risk Regulation , Volume 4 , Issue 1 , March 2013 , pp. 97 - 100
Copyright
Copyright © Cambridge University Press 2013

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References

1 COM(2012) 542.

2 COM(2012) 541.

3 There is reportedly an increasing trend in EU medicines agencies of “medical device” applications for food supplement products which have been rejected under the strict EU health claims framework, set out in Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods, OJ 2006 L 404/9). See: Shane Starling, “EU medical devices route tempts article 13 health claim losers”, 3 January 2013, available on the Internet at: <http://www.nutraingredients.com/Regulation/EU-medical-devices-route-temptsarticle-13-health-claim-losers> (last accessed on 3 January 2013).

4 OJ 1990 L 189/17.

5 OJ 1993 L 169/1.

6 OJ 1998 L 331/1.

7 COM(2012) 540 final.

8 OJ 2011 C 202/7.

9 European Parliament Document P7_TA(2012)0262.

10 See on the Internet at: <http://www.ghtf.org> (last accessed on 3 January 2013).

11 See on the Internet at: <http://www.imdrf.org> (last accessed on 3 January 2013).

12 WTO Doc. G/TBT/N/EU/71 and WTO Doc. G/TBT/N/EU/72.

13 WTO Doc. G/TBT/N/BRA/440.

14 OJ 2002 L 31/1.

15 OJ 2003 L 268/24.

16 OJ 2004 L 10/5.