Certification of Medical Devices: Lessons from the PIP Scandal

Abstract

In medical devices law, certification by private organisations substitutes pre-market control by public authorities. Certification of medical devices has attracted wide attention through the scandal around cheap and defective breast implants that were produced and distributed by the French producer Poly Implant Prothese (PIP) and whose product design was certified by TUV Rheinland as being safe. The scandal triggered litigation, in particular in German and French courts, that ultimately reached the Court of Justice. At the legislative level, the EU has reacted with numerous measures to improve the certification process, and also the accreditation of certification bodies. This chapter analyses and contextualises the public law control and complementary tort liability (de lege lata or de lege ferenda) as necessary elements of a functioning system of the safety of medical devices.