Case T-764/21: Action brought on 8 December 2021 — Atesos medical and Others v Commission
Date: 2021-12-08
Institutions: General Court
Subjects: EC conformity marking, Switzerland, abuse of power, agreement (EU), approval, medical device, mutual recognition principle, principle of legal certainty, rights of the defence








C_2022095EN.01003901.xml










28.2.2022   


EN


Official Journal of the European Union


C 95/39






Action brought on 8 December 2021 — Atesos medical and Others v Commission
(Case T-764/21)
(2022/C 95/55)
Language of the case: English

Parties


Applicants: Atesos medical AG (Aarau, Switzerland) and 7 other applicants (represented by: M. Meulenbelt, B. Natens and I. Willemyns, lawyers)

Defendant: European Commission

Form of order sought

The applicants claim that the Court should:






—


annul the unpublished defendant’s decision of an unknown date which falsely asserts the expiry of the designation of Schweizerische Vereinigung für Qualitäts — und Management Systeme (‘SQS’) as a conformity assessment body for medical devices under Directive No 93/42/EEC concerning medical devices, and that delists SQS from the European Commission’s New Approach Notified and Designated Organizations database with effect from 28 September 2021; and










—


order the defendant to pay the costs.





Pleas in law and main arguments

In support of the action, the applicants rely on four pleas in law.






1.


First plea in law, alleging that the defendant violated Article 296 TFUE and Articles 5(1), 5(2) and 13(2) TEU.










2.


Second plea in law, alleging that the defendant misused its powers.










3.


Third plea in law, alleging that the defendant infringed Article 218(9) TFEU and Articles 8, 18, 19 and 21 of the ‘EU-Swiss MRA’ (1), the right to be heard as reflected in Article 41(2) of the Charter of Fundamental Rights, the right of defence and the general principle of fraus omnia corrumpit.











4.


Forth plea in law, alleging that the defendant infringed Article 120 of Regulation (EU) No 2017/745 (2) and Articles 1 (juncto 20) and 5 of the ‘EU-Swiss MRA’, as well as the general principles of effectiveness, legal certainty and legitimate expectations.






(1)  Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment — Final Act — Joint Declarations — Information relating to the entry into force of the seven Agreements with the Swiss Confederation in the sectors free movement of persons, air and land transport, public procurement, scientific and technological cooperation, mutual recognition in relation to conformity assessment, and trade in agricultural products (OJ 2002 L 114, p. 369), as amended by Decision no 2/2017 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment of 22 December 2017 on the amendment of Chapter 2 on Personal protective equipment, Chapter 4 on medical devices, Chapter 5 on gas appliances and boilers and Chapter 19 on Cableway installations [2018/403] (OJ 2018 L 72, p. 24-41).

(2)  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/EEC (Text with EEA relevance) (OJ 2017 L 117, p. 1-175).