Are Notified Bodies Responsible for the Failure of Companies They Oversee?

Regulatory NewsRegulatory News | 10 April 2015 |  By 

A legal battle in Germany to determine responsibility in the aftermath of the Poly Implant Prothese (PIP) breast implant scandal will be put on hold while a German court asks for clarification from the European Court of Justice (ECJ), Deutsche Welle reports.


For many years, PIP was one of the largest producers of silicone breast implants. However, after it came to light that the company used industrial-grade silicone in its implants, the company shut down after it was sued in several countries and its owner sentenced to prison. At the same time, health authorities scrambled to determine a course of action, which ranged from careful monitoring to recommending the implants be preemptively removed.

In several of the suits, the plaintiffs also pointed to TÜV Rheinland, a notified body based in Germany. Plaintiffs claimed the company was negligent in its duties to certify PIP's quality management system (QMS) and design dossier for the implants.

In 2013, a French court found TÜV liable for failing to perform its duties for not identifying that the silicone used was not authorized for use in the implants, and ordered the company to pay compensation to the 1,700 women represented in the case. The following year, the Court of Appeals of Aix-en-Provence rejected an appeal by TÜV to reverse the decision.

Suit in Germany

Because PIP is no longer in business, plaintiffs have had to look elsewhere for compensation. TÜV says it is facing roughly 10 suits related to the implants and has claimed it performed its required duties and should not be held liable for fraud committed by a company it reviewed.

The plaintiff in one of these cases is seeking €40,000 in compensation for having her PIP implants removed in 2012, saying TÜV should not have certified the implants as safe. Her case reached Germany's Federal Supreme Court on appeal after being rejected twice by lower courts.

Now the case has been put on hold while the German court awaits clarification on several points of law from the ECJ. The Judge for the German court has said, "The critical question is what monitoring and supervisory controls TÜV had."

The ECJ's advice is likely to impact the ruling in the case and could potentially affect the other outstanding suits against TÜV.


Deutsche Welle


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