Order of the General Court (Ninth Chamber) of 2 July 2020

Data

Court: General Court

Case date: 2 juli 2020

Verdict

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)"

Actions for failure to actNatural or legal personsMeasures of direct and individual concern to themNotification by a Member State of a decision prohibiting the placing on the market of a medical deviceFailure by the Commission to adopt an act under Directive 93/42Applicant not being directly concerned by such an actInadmissibility

(Arts 263 and 265 TFEU; Council Directive 93/42, Art. 8(1) and (2))

(see paras 42-47)

Actions for failure to actInstitution called upon to actConditionsClear and express requestNo precise formal rulesLetter 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)

Actions for failure to actTime limitsClaim barred by lapse of timePossibility to rely on the principle of the protection of legitimate expectationsCondition

(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

The action is dismissed as inadmissible.

Mr Christoph Klein shall pay the costs.