Last week, a German court referred a liability case involving breast implants to the Court of Justice of the European Union (CJEU) to provide further clarity on the responsibilities and liability scheme for medical devices in the European Union. The key questions relate to the responsibility of the Notified Bodies, which are in charge of granting the CE mark that is required to place medical devices on the EU market. The CJEU’s answer will have an impact on the work of Notified Bodies in the EU and could also be relevant for the liability of medical device manufacturers in the EU.

The German plaintiff in the case had sued the Notified Body — TÜV Rheinland — for damages when the breast implant manufacturer went bankrupt. TÜV Rheinland was the Notified Body for the devices and in charge of conducting the conformity assessment pursuant to Article 11 of the Medical Devices Directive 93/42/EEC. This included the auditing of the manufacturer’s quality management system, the examination of the design of the product, and postmarket surveillance. In her claim, the plaintiff alleged that TÜV Rheinland did not comply with these obligations. She further argued that if TÜV Rheinland had adequately reviewed the manufacturer’s business records and conducted unannounced audits and product tests, the Notified Body would have detected misconduct and stopped the devices from being placed on the market.

Before deciding the case, the German Federal Court of Justice (BGH) has asked the CJEU to address the question whether the work of a Notified Body is supposed to have a protective effect towards patients such that patients are entitled to claim damages directly from the Notified Body. The lower German courts had dismissed the plaintiff’s claims, holding that the legal purpose of the Notified Body’s activities did not aim to protect potential patients. In contrast to the German lower courts, plaintiffs have been successful in the French courts in obtaining verdicts against TÜV Rheinland.

The decision of the CJEU should provide useful clarity on the scope of responsibilities of Notified Bodies in the EU, so that divergent decisions in different EU Member States on the same issue can be avoided. If this case should confirm a liability of the Notified Body, a subsequent question will be what this means for the product liability of the medical devices manufacturers.

Overall, medical devices manufacturers need to be more cautious with respect to their product liability risks and medical devices vigilance obligations in the EU. This is recommended in the light of the recent CJEU decision in which the court substantially increased the product liability risks for medical devices manufacturers in the EU (Judgment of the CJEU of 5 March 2015 in joined cases: C-503/13 and C-504/13).