EU Court of Justice explains product liability for Notified Bodies

The European Court of Justice (ECJ) has passed judgement on product liability in a case concerning infamous faulty breast implants made by the French manufacturer Poly Implant Prothese (PIP). In 2010, PIP was found to have used industrial-grade silicone in its implants that did not met with EU quality standards.


Following unsuccessful patient claims against TÜV in France and Germany, the German Federal Court of Justice referred a number of questions about Notified Body obligations to the ECJ:

  • Whether they can be found liable to patients if they infringe on their obligations to inspect device makers?
  • Whether they are obligated to examine devices
  • Whether they are obligated to look at device markers’ business records and carry out unannounced inspections.

The ECJ has clarified the obligations of Notified Bodies concerning product liability rather than determined whether the German Notified Body TÜV Rheinland was liable in this specific case.

The court explained that:

  • Notified Bodies are not under a general obligation to carry out unannounced inspections, to examine devices and/or to examine the manufacturer’s business records.
  • When there is evidence that a device is non-compliant with EU standards, a Notified Body should take “all the steps necessary” to ensure that they meet their obligations to ensure the device is in conformity with the Directive.
  • Determining whether a Notified Body is liable for damages caused by a device is governed by national law.
    So now it will be down to the German Federal Court of Justice to determine whether TÜV took the necessary steps to meet its obligations as a Notified Body.

To read the ECJ Press Release, please click here.