Quality auditors of medical devices under no general obligation to ensure conformity

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 has 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. She has also sought a declaration that TÜV is liable for any future material damage. In her view, 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.

According to the Bundesgerichtshof (Federal Court of Justice, Germany), in order for TÜV to incur liability, it must have infringed a rule conferring legal protection or a contractual obligation. In order to establish whether there was such an infringement, the Bundesgerichtsthof has asked the Court of Justice to interpret, as a preliminary issue, the relevant EU legislation, namely Directive 93/42 concerning medical devices. That directive harmonises the requirements to be met by medical devices, such as breast implants, in order for them to be placed on the market.

It governs, inter alia, the procedure relating to the EC declaration of conformity and the tasks and obligations of notified bodies involved in the quality assurance system.

In its judgment, the court found that, under that directive, a notified body, such as TÜV, which is involved in the procedure relating to the EC declaration of conformity, is not under a general obligation to carry out unannounced inspections, to examine devices and/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 fulfills its obligations under the directive.

The court also 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 fulfill its obligations under the directive in connection with that procedure 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.