Case T-430/25: Action brought on 7 July 2025 – Klein v Commission
Date: 2025-07-07
Institutions: General Court
Subjects: indemnification, interest, market approval, medical device, operation of the Institutions








C_202504628EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/4628


25.8.2025






Action brought on 7 July 2025 – Klein v Commission


(Case T-430/25)

(C/2025/4628)
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:






—


declare, by interim judgment, that the European Commission must compensate the applicant for the damage suffered by Broncho-Air Medizintechnik AG as a result of the Commission’s failure to act in the safeguard clause procedure in relation to the medical device ‘Inhaler Broncho-Air’ for the period from 8 March 1988 until the device can be sold again;










—


in the event that compensation is due pursuant to [the first indent], order the parties to reach an agreement on the extent of damage for which compensation is payable within the timeframe specified by the General Court;










—


in the event that no agreement can be reached on the extent of the damage, request an expert opinion to determine the extent of the damage incurred using recognised economic methods;










—


once the extent of the damage has been determined, order the European Commission to pay the amount determined, plus interest at a rate of 3.5 % above the rate applied by the ECB for main refinancing operations, from the date on which the damage occurred;










—


order the Commission to bear the costs of the proceedings, including those incurred in assessing the damage.





Pleas in law and main arguments

The applicant alleges that the Commission committed two sufficiently serious infringements of Article 41 of the Charter of Fundamental Rights of the European Union (1) by failing to act in the safeguard clause procedure. Those infringements are ongoing and affect the applicant’s rights.
In the alternative, the applicant alleges two sufficiently serious infringements of Article 8 of Directive 93/42/EEC (2) and Articles 94 to 97 of Regulation 2017/745. (3)

It claims that there is a sufficient causal link between the failure to act and the ongoing damage suffered by Broncho-Air Medizintechnik AG in that the latter cannot sell the medical device until the Commission has taken a decision pursuant to Article 8(2) of Directive 93/42/EEC.
The limitation period set out in Article 46 of the Statute of the Court of Justice of the European Union has not yet expired.


(1)  
            OJ 2012 C 326, p. 391.

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

(3)  Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ 2017 L 117, p. 1).


ELI: http://data.europa.eu/eli/C/2025/4628/oj
ISSN 1977-091X (electronic edition)