Judgment of the General Court (Eighth Chamber) of 28 September 2016 — Klein v Commission

(Case T‑309/10 RENV)

Non-contractual liability — Directive 93/42/EEC — Harmonised system for the safety and health protection of patients, users and, where appropriate, other persons, with regard to the use of medical devices — Article 8 — Notification of a decision prohibiting placing on the market — No position adopted by the Commission — Article 18 — Wrongful CE marking — Harm — Sufficiently serious breach of a rule of law conferring rights on individuals — Causal link

1.                     Non-contractual liability — Conditions — Unlawfulness —Damage — Causal link — Cumulative conditions — No obligation on the court to examine in a given order — One of those conditions not met — Claim for compensation dismissed in its entirety (Art. 340, second para., TFEU) (see paras 38, 39, 84)

2.                     Non-contractual liability — Conditions — Sufficiently serious breach of a rule of law intended to confer rights on individuals — Discretion of the institution when adopting the measure — Need to be taken into consideration when examining liability (Art. 340, second para., TFEU) (see paras 43-45)

3.                     Judicial proceedings — Introduction of new pleas during the proceedings — Conditions — Application to the proceedings after reference back following an appeal (Rules of Procedure of the General Court; Arts 84(1), and 218) (see para. 46)

4.                     Non-contractual liability — Conditions — Sufficiently serious breach of a rule of law intended to confer rights on individuals — Rule of law intended to confer rights on individuals — Definition — Notification of a decision prohibiting marketing — Not included (Art. 340, second para., TFEU; Directive 93/42, Art. 8(2)) (see paras 59, 67)

5.                     Non-contractual liability — Conditions — Causal link — Concept — Burden of proof (Art. 340, second para., TFEU) (see paras 70, 71, 73, 81, 83)

Re:

APPLICATION on the basis of Article 268 TFEU seeking compensation for the harm allegedly suffered by the applicant as a result of breach by the Commission of its obligations under Article 8 of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1).

Operative part

The Court:

1. Dismisses the action;

2. Orders Mr Christoph Klein, the European Commission and the Federal Republic of Germany to bear their own costs.