# C_2018399EN.01000902.xml

| 5.11.2018 | EN | Official Journal of the European Union | C 399/9 |
| --- | --- | --- | --- |

5.11.2018

EN

Official Journal of the European Union

C 399/9

---

Judgment of the Court (Third Chamber) of 6 September 2018 — Christoph Klein v European Commission, Federal Republic of Germany

(Case C-346/17 P) (1)

((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))

(2018/C 399/11)

Language of the case: German

Parties

Appellant: Christoph Klein (represented by: H.-J. Ahlt, Rechtsanwalt)

Other parties to the proceedings: European Commission (represented by: G. von Rintelen, A. Sipos and A.C. Becker, acting as Agents), Federal Republic of Germany

Operative part of the judgment

The Court:

| 1. | 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; |
| --- | --- |

1.

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;

| 2. | Dismisses the appeal as to the remainder; |
| --- | --- |

2.

Dismisses the appeal as to the remainder;

| 3. | 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; |
| --- | --- |

3.

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;

| 4. | 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; |
| --- | --- |

4.

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;

| 5. | Orders the Federal Republic of Germany to bear its own costs in relation to the proceedings at first instance. |
| --- | --- |

5.

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

---

(1)  OJ C 300, 11.9.2017.

---