Comfort for notified body in breast implant case

16/02/17

The CJEU ruled on 16 February in a judgment that offers some comfort for notified bodies charged with the inspection of processes under Directive 93/42 concerning medical devices.

In 2008, Mrs Elisabeth Schmitt had breast implants manufactured in France fitted in Germany. After the French authorities established in 2010 that the French manufacturer had produced breast implants using industrial silicone which did not comply with quality standards, Mrs Schmitt had the implants removed. In the meantime, the manufacturer became insolvent.

Before the German courts, Mrs Schmitt claimed from TÜV Rheinland, the body appointed by the manufacturer to audit its quality system for the purposes of EC certification, €40 000 by way of compensation for non-material damage, claiming that an inspection of the delivery notes and invoices would have enabled TÜV to ascertain that the manufacturer had not used an approved form of silicone. A large number of other claims have been brought in various jurisdictions.

The CJEU found that under that directive, a notified body, such as TÜV is not under a general obligation to carry out unannounced inspections, to examine devices or to examine the manufacturer’s business records. However, in the face of evidence indicating that a medical device may not comply with the requirements laid down in the directive, the notified body must take all the steps necessary to ensure that it fulfils its obligations under the directive.

The Court found that the purpose of the notified body’s involvement in the procedure relating to the EC declaration of conformity is to protect the end users of medical devices. However, the conditions under which culpable failure by that body to fulfil its obligations may give rise to liability on its part vis-à-vis end users are governed by national law, subject to the principles of equivalence and effectiveness.

The Judgment appears here.