# C_2023321EN.01005601.xml

| 11.9.2023 | EN | Official Journal of the European Union | C 321/56 |
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11.9.2023

EN

Official Journal of the European Union

C 321/56

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Action brought on 7 July 2023 — Klein v Commission

(Case T-394/23)

(2023/C 321/62)

Language of the case: German

Parties

Applicant: Christoph Klein (Großgmain, Austria) (represented by: H.-J. Ahlt, lawyer)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

| — | annul Commission Implementing Decision C(2023)2961 final of 28 April 2023, entitled ‘Commission Implementing Decision on a measure prohibiting the placing on the market of the medical device “Inhaler Broncho-Air”, manufactured by Primed Halberstadt Medizintechnik GmbH on behalf of Broncho-Air Medizintechnik AG’; |
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annul Commission Implementing Decision C(2023)2961 final of 28 April 2023, entitled ‘Commission Implementing Decision on a measure prohibiting the placing on the market of the medical device “Inhaler Broncho-Air”, manufactured by Primed Halberstadt Medizintechnik GmbH on behalf of Broncho-Air Medizintechnik AG’;

| — | order the defendant to pay the costs of the proceedings. |
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order the defendant to pay the costs of the proceedings.

Pleas in law and main arguments

The action is based on the following three pleas in law.

| 1. | First plea in law, alleging that the decision infringes essential procedural requirements, namely






  — | those requirements relating to informing the Member States under Article 8(3) and (4) of Directive 93/42/EEC, (1) since no involvement of the Member States has ever taken place over the course of the 25-year duration of the safeguard clause procedure; |
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1.

First plea in law, alleging that the decision infringes essential procedural requirements, namely

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those requirements relating to informing the Member States under Article 8(3) and (4) of Directive 93/42/EEC, (1) since no involvement of the Member States has ever taken place over the course of the 25-year duration of the safeguard clause procedure;

| — | the obligation to state reasons under Article 296 TFEU. |
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the obligation to state reasons under Article 296 TFEU.

| 2. | Second plea in law, alleging that the decision infringes the Treaties or rules of law relating to their application, namely






  — | Article 41 of the Charter of Fundamental Rights of the European Union, (2) since the decision infringes the right to be heard by disregarding the submissions made by the applicant in the safeguard clause procedure and, accordingly, is not well-founded; |
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2.

Second plea in law, alleging that the decision infringes the Treaties or rules of law relating to their application, namely

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Article 41 of the Charter of Fundamental Rights of the European Union, (2) since the decision infringes the right to be heard by disregarding the submissions made by the applicant in the safeguard clause procedure and, accordingly, is not well-founded;

| — | the principle of proportionality, since the defendant did not carry out any assessment of the prohibition measure and disregarded the submissions made by the applicant in relation to its product. The applicant maintains that the measure is neither suitable nor necessary. |
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the principle of proportionality, since the defendant did not carry out any assessment of the prohibition measure and disregarded the submissions made by the applicant in relation to its product. The applicant maintains that the measure is neither suitable nor necessary.

| 3. | Third plea in law, alleging misuse of powers since the defendant, by its decision, does not pursue any legitimate aim. |
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3.

Third plea in law, alleging misuse of powers since the defendant, by its decision, does not pursue any legitimate aim.

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(1)  Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1).

(2)  
  OJ 2012 C 326, p. 391.

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