Opinion of the Advocate General — ECLI:EU:C:2018:206
Date: 2018-03-21
Language of the case: German
Subject matter: Provisions governing the Institutions;Public health
Procedure: Appeal - unfounded;Appeal - inadmissible;Judgment delivered after back reference;Action for damages;Appeal - successful
Origin: Austria

Summary — Judgment of the Court (Third Chamber), 6 September 2018 1. Non-contractual liability — Conditions — Unlawfulness — Sufficiently serious breach of EU law (Art. 340, second para., TFEU) 2. Approximation of laws — Medical devices — Directive 93/42 — Placing on the market — Member State using the safeguard clause in case of health or safety risk — Commission’s finding that the measures taken were unjustified — Rights to compensation of the manufacturer or his authorised representative — Possibility for the inventor of a device to rely on such rights — No such possibility (Council Directive 93/42, Art. 8) 3. Appeal — Grounds — Incorrect assessment of the facts and evidence — Inadmissibility — Review by the Court of the assessment of the facts and evidence — Possible only where the clear sense of the evidence has been distorted (Art. 256(1), second para., TFEU; Statute of the Court of Justice, Art. 58, first para.; Rules of Procedure of the Court of Justice, Art. 168(1)(d)) 4. Non-contractual liability — Conditions — Actual and certain damage — Burden of proof — Material damage consisting of procedural costs and lawyers’ fees paid in connection with an action against a prohibition decision adopted by national authorities in relation to a medical device and the absence of a Commission decision — No calculation or estimation of the damage — Rejection (Art. 340, second para., TFEU; Council Directive 93/42, Art. 8(2)) 1. See the text of the decision. (see paras 60, 61) 2. It is clear from the very wording of the second indent of Article 8(2) of Directive 93/42, concerning medical devices, that rights to compensation may be conferred only on the manufacturer of the medical device or his authorised representative under Article 8 of that directive. Consequently, the inventor of the medical device at issue, may not rely on rights to compensation associated with his personal situation. (see paras 93, 94) 3. See the text of the decision. (see paras 124-126) 4. The damage for which compensation is sought in an action to establish non-contractual liability on the part of the European Union, under the second paragraph of Article 340 TFEU, must be actual and certain, which it is for the appellant to prove. It is for the latter to adduce conclusive proof as to both the existence and the extent of the damage he alleges. 5. As regards alleged material damage consisting of procedural costs and lawyers’ fees paid in connection with an action against a decision of national authorities prohibiting the placing on the market of a medical device, due to the absence of a Commission decision on the basis of Article 8(2) of Directive 93/42, concerning medical devices, it is true that determination of such damage may involve some specificities relating, in particular, to the fact that the action had not been concluded at the time the application initiating proceedings was lodged. Nevertheless, the appellant may not be entirely excused from the obligation to adduce proof of the damage he claims to have suffered. It falls to him, in relation to that type of material damage, to adduce evidence both of the existence of the damage and of the data on which he has based his assessment of that damage, given that such an assessment may not be performed merely on an equitable basis. Accordingly, it is not sufficient that the appellant referred only to procedural costs and lawyers’ fees paid in connection with the action without in any way quantifying the extent of such expenses, either by calculation or estimation. (see paras 147, 151-153)