The Liability of Notified Bodies Under the EU's New Approach: The Implications of the PIP Breast Implants Case (C-219/15)

European Law Review, Forthcoming

Tilburg Private Law Working Paper Series No. 8/2017

19 Pages Posted: 20 Sep 2017

Date Written: September 18, 2017

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 (i) the impact of the judgment on the damages actions women have brought against TÜV Rheinland before national courts; (ii) the future regulation of medical devices in the EU; and (iii) 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.

Keywords: Notified Bodies, Private Standards, Certification, Liability, New Approach, Medical Devices

Suggested Citation

Verbruggen, Paul and Van Leeuwen, Barend, The Liability of Notified Bodies Under the EU's New Approach: The Implications of the PIP Breast Implants Case (C-219/15) (September 18, 2017). European Law Review, Forthcoming; Tilburg Private Law Working Paper Series No. 8/2017. Available at SSRN: https://ssrn.com/abstract=3038830

Paul Verbruggen (Contact Author)

Tilburg Law School ( email )

Tilburg, 5000 LE
Netherlands

Barend Van Leeuwen

Durham University ( email )

Old Elvet
Mill Hill Lane
Durham, Durham DH1 3HP
United Kingdom

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