News
Liability of certifying bodies in case of defects of a medical device
- 26/09/2016
The German Federal Court of Justice has submitted to the European Court of Justice a case concerning the liability of bodies certifying medical devices for breach of their duties of quality control (Directive 93/42/EEC of the Council of 14th June 1993, regarding the safety of products).
The Advocate General, in his conclusions of 15th September in the case C-219/15, has stated the liability of certifying bodies, when they come to know about the defectiveness of a medical device and nevertheless they do not verify if the certification of that device may be confirmed.
The Advocate General has reached such conclusions after realizing that, in a similar case, the Court of Justice had already ascertained the liability of importers for breach of specific duties as to the safety of products (Judgment C-40/04 of 8th September 2015).
If the position of the Advocate General were sustained by the Court of Justice, this would determine important economic repercussions due to the claims that will be filed. In that case, the Advocate General himself has suggested that the Court may set a time limit with regard to the effects of its Judgment.
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