62019TO0562(01)_INF
Order of the General Court (Eighth Chamber) of 25 April 2023 –Klein v Commission
(Case T‑562/19 RENV)
(Actions 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 – Repeal of Directive 93/42 – Articles 94 to 97 of Regulation (EU) 2017/745 – Market surveillance measures – Action manifestly well founded)
Actions for failure to act – Commission under an obligation to act – Safeguard clause procedure – Inaction by the Commission following notification by a Member State of a decision prohibiting the placing of a medical device on the market – Obligation to consult with the parties concerned on the justification for that prohibition – Failure to act
(Art. 265 TFEU; Council Directive 93/42, Art. 8(1) and (2))
(see paragraphs 18-20, 23, operative part 1)
Operative part
1.
The European Commission has failed to fulfil its obligations under Article 8(2) of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices by failing to act in the safeguard clause procedure initiated on 7 January 1998 by the Federal Republic of Germany and to take a decision in accordance with Directive 93/42, replaced by 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, in relation to the Inhaler Broncho-Air® device.
2.
The Commission shall pay the costs related to the appeal proceedings before the Court in Case C‑430/20 P and those related to the initial proceedings in Case T‑562/19 and to the proceedings referred back to the General Court in Case T‑562/19 RENV.