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

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