62019TO0562_INF
Order of the General Court (Ninth Chamber) of 2 July 2020 –Klein v Commission
(Case T‑562/19)
(Action for failure to act – Medical devices – Article 8(1) and (2) of Directive 93/42/EEC – 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 Commission – Out of time – Inadmissibility)
1.
Actions for failure to act – Natural or legal persons – Measures of direct and individual concern to them – Notification by a Member State of a decision prohibiting the placing on the market of a medical device – Failure by the Commission to adopt an act under Directive 93/42 – Applicant not being directly concerned by such an act – Inadmissibility
(Arts 263 and 265 TFEU; Council Directive 93/42, Art. 8(1) and (2))
(see paras 42-47)
2.
Actions for failure to act – Institution called upon to act – Conditions – Clear and express request – No precise formal rules – Letter allowing the institution concerned to make a concrete examination of the content of the requested decision
(Art. 265, second para., TFEU)
(see paras 61, 62)
3.
Actions for failure to act – Time limits – Claim barred by lapse of time – Possibility to rely on the principle of the protection of legitimate expectations – Condition
(Art. 265, second para., TFEU)
(see para. 71)
Re:
Application under Article 265 TFEU for a declaration that the Commission unlawfully failed to act in the safeguard clause procedure initiated by the Federal Republic of Germany on 7 January 1998 and adopt a decision in accordance with Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1) in respect of the device Inhaler Broncho Air®.
Operative part
1.
The action is dismissed as inadmissible.
2.
Mr Christoph Klein shall pay the costs.