62023TJ0394_INF
Judgment of the General Court (Eighth Chamber) of 12 February 2025 –Klein v Commission
(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)
1.
Acts of the institutions – Temporal application – Procedural rules – Application to proceedings pending at the time when such rules enter into force
(see paragraphs 48, 49)
2.
Action for annulment – Pleas in law – Infringement of essential procedural requirements – Scope – Infringement of procedural rules – Commission decision confirming a measure taken by national authorities to prohibit the placing on the market of a medical device – Infringement of the conditions for adopting such a decision – Annulment of the decision
(Art. 263 TFEU; European Parliament and Council Regulation 2017/745, Art. 96(1))
(see paragraphs 52-56, 66-69)
Operative part
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.