The legal framework on medical devices is widely harmonized in Europe. Notified bodies (usually private testing organisations) have to verify whether medical devices and their manufacturers meet the requirements of the pertinent norms. Such tests are a prerequisite for affixing the CE-sign to medical devices which again is a prerequisite for selling such products.
The German Federal Supreme Court this week has asked the European Court of Justice (ECJ) whether such a notified body may be held directly liable for damages suffered by a patient, if the body has negligently breached its duties.
The further questions of the Federal Supreme Court concern the obligation of the notified bodies to perform product tests and unannounced inspections.
The referral of the Federal Supreme Court is based upon a complaint of a patient against TÜV Rheinland for damages caused by breast implants of the insolvent French company PIP which were made of cheap industry silicone.