Judgment in Case C-219/15 Elisabeth Schmitt v TÜV Rheinland LGA Products GmbH

The European Court of Justice delivered on 16 February 2017 its judgement in a case involving breast implants made of inferior quality industrial silicone.

Germany's Federal Court of Justice asked the Court of Justice to interpret the relevant EU legislation, namely Directive 93/42/EEC concerning medical devices.

The Court found that, under this Directive, a notified body 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 musttake all the steps necessary to ensure that it fulfills its obligations under the directive.

It 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 culpabl 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.

The Court's Advocate-General had provided an Opinion on this case in September 2016.