Regulating certification bodies in the field of medical devices: The PIP breast implants litigation and beyond

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

This article uses the breast implants scandal around the French producer Poly Implant Prothèse (PIP) to discuss the regulation of medical devices in EU law. Thereby, the specific focus is on the role of tort liability of certification bodies in complementing the public law regime of medical devices law. As tort law has not been harmonised yet at the level of EU law, national legal systems may produce different results; which indeed the PIP case demonstrates, with diverging judgments from French and German courts. Showing the deficiencies of the public law system of the Medical Devices Directive of 1993 as well as of the new Medical Devices Regulation of 2017, the article argues that tort liability is a necessary regulatory instrument to ensure that certification bodies live up to their duties under medical devices law and therefore a necessary instrument for the protection of the health and safety of patients.
TidsskriftEuropean Review of Private Law
Udgave nummer2
Sider (fra-til)403-428
Antal sider26
StatusUdgivet - 2019

ID: 217075830