It is the opinion of Advocate General Sharpston that notified bodies which monitor the quality assurance systems of manufacturers of medical devices may be liable to patients if they fail to fulfil their obligations resulting from the EU’s product safety rules.

The verdict of Advocate General Sharpston in Case C-219/15 Schmitt v TÜV Rheinland before the European Court of Justice (ECJ) in Luxembourg was highly anticipated. This dealt with a request from the Bundesgerichtshof for a preliminary ruling regarding Medical Devices Directive 93/42/EEC, specifically the obligation to monitor products and the associated liability regarding the use of substandard medical devices. In this specific case, a woman from Germany had silicone breast implants fitted that were made of lowgrade industrial silicon. The woman brought an action to seek compensation for suffering.  

 

As stated in the ECJ Press Release of 15 September 2016, it is the opinion of Advocate General Sharpston that notified bodies which monitor the quality assurance systems of manufacturers of medical devices may be liable to patients if they fail to fulfil their obligations resulting from the EU’s product safety rules.  

 

If a notified body is made aware that a medical device may be defective, it must employ all available measures to determine whether its certification of the product stands. Although the Directive places primary liability for product compliance on the manufacturer, this does not exclude this liability from being extended to others. In its judgement from 8 September 2005 (C-40/04), the ECJ had already decided that national legislation may impose liability on importers for obligations regarding EU product safety rules. 

 

Given the serious economic impact of her proposed solution, the Advocate General has suggested that the ECJ limit the temporal effect of its ruling. Judgement is pending.