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Document 62024CN0010
Case C-10/24, Cattani: Request for a preliminary ruling from the Bundesgerichtshof (Germany) lodged on 9 January 2024 — Dürr Dental SE v Cattani Deutschland Helmes GmbH & Co. KG
Case C-10/24, Cattani: Request for a preliminary ruling from the Bundesgerichtshof (Germany) lodged on 9 January 2024 — Dürr Dental SE v Cattani Deutschland Helmes GmbH & Co. KG
Case C-10/24, Cattani: Request for a preliminary ruling from the Bundesgerichtshof (Germany) lodged on 9 January 2024 — Dürr Dental SE v Cattani Deutschland Helmes GmbH & Co. KG
OJ C, C/2024/2287, 2.4.2024, ELI: http://data.europa.eu/eli/C/2024/2287/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
Official Journal |
EN C series |
C/2024/2287 |
2.4.2024 |
Request for a preliminary ruling from the Bundesgerichtshof (Germany) lodged on 9 January 2024 — Dürr Dental SE v Cattani Deutschland Helmes GmbH & Co. KG
(Case C-10/24, Cattani)
(C/2024/2287)
Language of the case: German
Referring court
Bundesgerichtshof
Parties to the main proceedings
Applicant, appellant on a point of law and cross-respondent on a point of law: Dürr Dental SE
Defendant, respondent in the appeal on a point of law and cross-appellant on a point of law: Cattani Deutschland Helmes GmbH & Co. KG
Questions referred
1. |
Is a distributor obliged under Article 14(1) and point (a) of the first subparagraph of Article 14(2) of Regulation (EU) 2017/745 (1) to verify whether the product which it makes available on the market is to be regarded as a medical device and therefore bears a CE marking as a medical device and that an EU declaration of conformity of a medical device has been drawn up by the manufacturer? |
2. |
Is it relevant for the answer to question 1 whether the product
|
3. |
Do the verification obligations imposed on the distributor under point (a) of the first subparagraph of Article 14(2) in conjunction with Article 14(1) of Regulation (EU) 2017/745 also include verification of whether the device is to fall under risk class IIa within the meaning of Regulation (EU) 2017/745 and must therefore also be marked with a four-digit identification number of a notified body? |
4. |
With respect to the question whether a distributor, under the third subparagraph of Article 14(2) in conjunction with Article 14(1) of Regulation (EU) 2017/745, has reason to believe that the device which it [has made] available on the market is not in conformity with the requirements of that regulation, is it relevant that the distributor is made aware by means of a letter of formal notice from a competitor of the latter’s legal opinion that the article made available on the market by the distributor does not bear the requisite CE marking and an identification number of a notified body in accordance with the requirements of point (a) of the first subparagraph of Article 14(2) of Regulation (EU) 2017/745? |
5. |
Is it relevant for the answer to question 4 whether
|
(1) 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 (OJ 2017 L 117, p. 1).
(2) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast) (OJ 2006 L 157, p. 24).
ELI: http://data.europa.eu/eli/C/2024/2287/oj
ISSN 1977-091X (electronic edition)