CJEU Case C-346/17 P / Judgment
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:

On those grounds, the Court (Third Chamber) hereby:

Sets 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 so far as it held that Mr Christoph Klein had not established the existence of a direct and sufficient causal link capable of engaging the European Union’s liability;

Dismisses the appeal as to the remainder;

Dismisses the action brought by Mr Christoph Klein seeking compensation for the damage allegedly sustained following a breach by the European Commission of its obligations under Article 8 of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices;

Orders Mr Christoph Klein and the European Commission to bear their own costs in relation to both the proceedings at first instance and the appeal proceedings;

Orders the Federal Republic of Germany to bear its own costs in relation to the proceedings at first instance.
Paragraphs referring to EU Charter

41) In support of his appeal, the appellant raises, in essence, seven grounds of appeal, alleging, first, infringement of the second paragraph of Article 61 of the Statute of the Court of Justice of the European Union in so far as the General Court was wrong to rule that the appellant’s second head of claim was inadmissible, secondly, infringement of the second paragraph of Article 61 of the Statute of the Court of Justice of the European Union in so far as the General Court erred in its assessment of the conditions to be satisfied in an action for damages, thirdly, infringement of Article 84(1) of the Rules of Procedure of the General Court in so far as the General Court was wrong to reject, on the basis that it was a new submission, the plea alleging infringement of Article 41 of the Charter of Fundamental Rights of the European Union (‘the Charter’) and of the principle of sound administration, fourthly, infringement of Article 8 of Directive 93/42 and Articles 28 et seq. TFEU in so far as those provisions confer rights on individuals, fifthly, an error committed by the General Court in its examination of a causal link between the Commission’s conduct and the alleged damage, sixthly, failure to take account of a draft Commission Decision, and seventhly, infringement of Article 6 of the European Convention for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950 (‘the ECHR’) and of Article 47 of the Charter in so far as the General Court was wrong to reject the request for further evidence submitted by the appellant.

42) In addition, on the basis of Article 41 of the Charter, the appellant requests that the Court of Justice order the Commission to produce its entire file relating to the safeguard clause procedure under Article 8 of Directive 93/42.

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68) By the third ground of appeal, the appellant notes that, in paragraph 46 of the judgment under appeal, the General Court rejected, on the basis that it was an inadmissible new submission, his claim that the Commission’s failure to act constituted a breach of Article 41 of the Charter and of the principle of sound administration.

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70) Thus, the appellant maintains that the plea alleging infringement of Article 41 of the Charter was not a new submission since the principles of ‘good administration’ and ‘sound administration’ overlap.

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72) However, in the judgment under appeal, the General Court did not examine that piece of evidence. In order for the trial to comply with the principle of equality of arms, the General Court should have given the appellant the opportunity, at least by way of a measure of organisation of procedure, to set out his views on the draft decision at issue. Consequently, the appellant claims that the General Court infringed the right to a fair trial enshrined in Article 6 of the ECHR and Article 47 of the Charter.

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75) The appellant maintains that, by rejecting that request, the General Court infringed Article 6 of the ECHR and Article 47 of the Charter.

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77) As regards the third ground of appeal, it is sufficient to note that the appellant has put forward the complaint alleging infringement of Article 41 of the Charter and of the principle of sound administration for the purposes of establishing that the conduct of the Commission was unlawful. Likewise, as regards the sixth and seventh grounds of appeal, the draft decisions produced by the Commission and ordering the Commission to produce its entire file relating to the safeguard clause procedure of 1998 would merely serve the same purpose.

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141) In his appeal, the appellant requests, on the basis of Article 41 of the Charter, that the Court of Justice order the Commission to produce the entire file relating to the safeguard clause procedure under Article 8 of Directive 93/42.