The European Court of Justice (ECJ) last week issued its long-awaited judgement on a case that heavily influenced the new revisions of the EU's Medical Device Directives.

But the court's decision was more about clarifying the role of notified bodies in a product liability case concerning faulty breast implants made by the now-defunct French manufacturer Poly Implant Prothese (PIP) and German notified body TÜV Rheinland than about deciding if the notified body was liable.

In its judgment, the ECJ clarified notified bodies' obligations under the Medical Devices Directive (Directive 93/24/EEC), saying 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."

The court said when there is evidence that a device is not in compliance with EU standards, they are required to "take all the steps necessary" to ensure that they meet their obligations to ensure the device is in conformity with the directive.

Additionally, the court clarified that notified bodies' role in certifying device conformity is "to protect the end users of medical devices," but that the conditions for determining whether a notified body is liable for damages caused by a device under the purview of national law.

Determining whether a notified body can be held liable for devices has proven to be a difficult legal question, according to at least one lawyer watching these developments.

In 2013, a French court ordered TÜV to compensate women who received the faulty implants; however, in 2015 a French court of appeals overturned the lower court's ruling, and ordered the plaintiffs to pay back the compensation they received. Last month, the lower court again found TÜV liable for the implants, though TÜV has said it would again appeal the decision.

Background

In 2010, French regulators discovered that PIP had been using industrial-grade silicone in its implants that did not comply with EU quality standards.

Following the discovery, PIP's founder was arrested and the company went bankrupt.

Unable to sue PIP for restitution, a patient in Germany whose faulty implants were removed in 2012 instead sued TÜV, which served as the company's notified body between 1998 and 2008. The plaintiff asked for ‎€40,000 and future damages, claiming that TÜV had not fulfilled its obligations to ensure PIP's implants conformed to EU device standards, while arguing that had TÜV inspected PIP's business records more thoroughly it would have found invoices and delivery notes for the industrial grade silicone.

However, these claims were rejected by a German court, and again during an appeal, with the appeal court arguing that TÜV could not be held liable in the matter as "the purpose of that notified body's activity was not to protect patients."

Referral to the ECJ

Following the appeal court's decision, the plaintiff appealed to the German Federal Court of Justice, which referred several questions to the ECJ.

The German Federal Court of Justice asked whether notified bodies can be found liable to patients if they infringe on their obligations to inspect device makers; whether notified bodies are obligated to examine devices; and whether notified bodies are obligated to look at device markers' business records and carry out unannounced inspections.

According to the German Federal Court of Justice, these questions are critical to establishing whether TÜV can be held liable under German law, as the notified body "must have infringed a rule conferring legal protection or a contractual obligation."

Now, with the clarifications from the ECJ on TÜV's obligations, the case can proceed in Germany, where the German Federal Court of Justice will be left to decide whether TÜV took the steps necessary to fulfill its obligations.

European Court of Justice

Press Release