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The liability of notified bodies under the EU's New Approach: the implications of the PIP breast implants case

Verbruggen, Paul; Van Leeuwen, Barend

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Authors

Paul Verbruggen



Abstract

In this article, we analyse the consequences of the CJEU’s judgment in Schmitt , a preliminary reference concerning the potential liability of the notified body TÜV Rheinland vis-à-vis women who had received breast implants produced by the French manufacturer Poly Implant Prothèse SA (PIP). Our discussion focuses on (1) the impact of the judgment on the damages actions that women have brought against TÜV Rheinland before national courts; (2) the future regulation of medical devices in the EU; and (3) the regulation of private standardisation and certification in EU law. We argue that Schmitt can be seen as part of a broader trend in the case law of the CJEU, in which private regulatory activities are gradually submitted to fundamental principles of EU law. While this "constitutionalisation" of private regulation strengthens the public accountability of these alternative forms of regulation, it also poses fundamental challenges to their current design and internal governance.

Journal Article Type Article
Acceptance Date Sep 15, 2017
Online Publication Date Jun 13, 2018
Publication Date Jun 13, 2018
Deposit Date Sep 18, 2017
Publicly Available Date Aug 27, 2020
Journal European Law Review
Print ISSN 0307-5400
Publisher Sweet and Maxwell
Peer Reviewed Peer Reviewed
Volume 43
Issue 3
Pages 394-409
Public URL https://durham-repository.worktribe.com/output/1376243
Publisher URL http://www.sweetandmaxwell.co.uk/Catalogue/ProductDetails.aspx?recordid=427&productid=6968

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Copyright Statement
This is a pre-copyedited, author-produced version of an article accepted for publication in European Law Review following peer review. The definitive published version Verbruggen, Paul & Van Leeuwen, Barend (2018). The liability of notified bodies under the EU's new approach: the implications of the PIP breast implants case. European Law Review 43(3): 394-409 is available online on Westlaw UK or from Thomson Reuters DocDel service.






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