Advocate General’s Opinion in Case C-219/15. Elisabeth Schmitt v TÜV Rheinland LGA Products GmbH

The European Court of Justice's Advocate General considered the bodies monitoring the quality system of manufacturers of medical devices may be liable to patients for failure to fulfill their duties arising from EU product safety rules.

If such a body is put on notice that a medical device may be defective, it is under a duty to take all necessary measures to determine whether its certification of that device may stand.

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.