Paul Verbruggen
The liability of notified bodies under the EU's New Approach: the implications of the PIP breast implants case
Verbruggen, Paul; Van Leeuwen, Barend
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.
Citation
Verbruggen, P., & Van Leeuwen, B. (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
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 | Mar 29, 2024 |
Journal | European Law Review |
Print ISSN | 0307-5400 |
Publisher | Sweet and Maxwell |
Peer Reviewed | Peer Reviewed |
Volume | 43 |
Issue | 3 |
Pages | 394-409 |
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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