A more detailed analysis of the impact of the work at the CJEU is featured in Clinica Medtech Intelligence.


Liability Spotlight now on the Notified Bodies

Background and Context

The so-called PIP-Breast-implant scandal now reaches the Court of Justice of the European Union (CJEU). As last week a German court referred a liability case to the CJEU, it is now upon the CJEU to provide further clarity on the responsibilities and liability scheme for medical devices in the EU. The key questions relate to the responsibility of the Notified Bodies which are in charge of granting the CE mark which again is required to place medical devices on the EU market. The CJEU’s answer will have an impact on the work of Notified Bodies and will be relevant for the liability of medical device manufacturers in the EU.

In the current case, the plaintiff has sued the German Notified Body TÜV Rheinland for damages as she had been implanted a PIP breast implant. PIP stands for the company name Poly Implant Prothèse which, for years, was illegally selling breast implants containing industrial silicone instead of the medical silicone for which they had received the CE mark. The founder of PIP and several former executives and managers were convicted of fraud and sentenced to jail by a court in France.
Continue Reading European Court to Clarify Responsibilities and Liability for Medical Devices