CJEU Case C-346/17 P / Opinion
Key facts of the case:

Appeal — Second paragraph of Article 340 TFEU — Non-contractual liability of the European Union — Directive 93/42/EEC — Medical devices — Article 8(1) and (2) — Safeguard clause procedure — Notification by a Member State of a decision prohibiting the placing on the market of a medical device — Absence of a decision by the European Commission — Sufficiently serious breach of a rule of law intended to confer rights on individuals — Causal link between the conduct of the institution and the damage alleged — Evidence of the existence and extent of the damage.

Outcome of the case:

Having regard to the foregoing considerations, I propose that the Court should:

Set aside the judgment of the General Court of the European Union of 28 September 2016, Klein v Commission, (T‑309/10 RENV, not published, EU:T:2016:570) in part in that it dismissed Mr Christoph Klein’s action on the ground that he had not established a direct and sufficient causal link, capable of rendering the European Union liable, with the alleged harm;

Dismiss the remainder of the appeal;

Refer the case back to the General Court of the European Union;

Reserve the costs.
Paragraphs referring to EU Charter
42) The appeal consists of eight grounds of appeal. The appellant claims:

by the first ground of appeal, incorrect application of the second paragraph of Article 61 of the Statute of the Court of Justice of the European Union, with the consequence that the second head of the form of order sought concerning the effecto device is admissible;

by the second ground of appeal, infringement of the second paragraph of Article 61 of the Statute of the Court of Justice of the European Union, with the consequence that the examination of his action is flawed, as the General Court misconstrued the scope of the judgment of the Court of Justice which conferred on him rights to compensation linked with his personal situation and with the rights transferred by atmed;

by the third ground of appeal, infringement of Article 84(1) of the Rules of Procedure of the General Court and of Article 41 of the Charter of Fundamental Rights of the European Union, ( 8 ) with the consequence that the head of the form of order whereby he sought a declaration that the Commission’s failure to act constitutes an infringement of Article 41 of the Charter and breach of the principle of good administration is admissible;

by the fourth ground of appeal, infringement, primarily, of Article 8 of Directive 93/42 and Article 28 et seq. TFEU, in that they confer rights on individuals;

by the fifth ground of appeal, incorrect legal classification of the facts giving rise to the existence of a causal link between the act and the alleged damage;

by the sixth ground of appeal, breach of the principle of a fair hearing and of the right to be heard and infringement of Article 6 of the Convention for the Protection of Human Rights and Fundamental Freedoms ( 9 ) and of Article 47 of the Charter, with the consequence that the General Court should have taken a proposal for a Commission decision (Annex COM RENV 1’) into account; and

by the seventh ground of appeal, infringement of Article 6 of the Convention for the Protection of Human Rights and Fundamental Freedoms and of Article 47 of the Charter, and of Article 63(3)(d) of the (former) Rules of Procedure of the General Court and of Article 24 of the Statute of the Court of Justice of the European Union, owing to the rejection of the claim that the Commission should be ordered to produce the entire file concerning the safeguard clause procedure.