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Case T-394/23: Judgment of the General Court of 12 February 2025 – Klein v Commission (Public health – EU regulatory framework governing medical devices – Safeguard clause – Article 8(1) and (2) of Directive 93/42/EEC – Notification by a Member State of a decision prohibiting the placing on the market of a medical device – Medical device Inhaler Broncho-Air® – Repeal of Directive 93/42 – Articles 94 to 97 of Regulation (EU) 2017/745 – Infringement of essential procedural requirements)
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Official Journal of the European Union
C series
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C/2025/1758
31.3.2025
(Case T-394/23)
(Public health - EU regulatory framework governing medical devices - Safeguard clause - Article 8(1) and (2) of Directive 93/42/EEC - Notification by a Member State of a decision prohibiting the placing on the market of a medical device - Medical device Inhaler Broncho-Air® - Repeal of Directive 93/42 - Articles 94 to 97 of Regulation (EU) 2017/745 - Infringement of essential procedural requirements)
(C/2025/1758)
Language of the case: German
Parties
Applicant: Christoph Klein (Großgmain, Austria) (represented by: H.-J. Ahlt, lawyer)
Defendant: European Commission (represented by: M. Noll-Ehlers, A. Spina and E. Sanfrutos Cano, acting as Agents)
Intervener in support of the defendant: Federal Republic of Germany (represented by: P.-L. Krüger and J. Möller, acting as Agents)
Re:
By his action under Article 263 TFEU, the applicant seeks the annulment of Commission Implementing Decision C(2023) 2961 final of 28 April 2023 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.
Operative part of the judgment
The Court:
1.Annuls Commission Implementing Decision C(2023) 2961 final of 28 April 2023 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;
2.Orders the European Commission to bear its own costs and to pay those incurred by Mr Christoph Klein;
3.Orders the Federal Republic of Germany to bear its own costs.
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OJ C 321, 11.9.2023.
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ELI: http://data.europa.eu/eli/C/2025/1758/oj
ISSN 1977-091X (electronic edition)
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