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)

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

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?

Is it relevant for the answer to question 1 whether the product

(a)    has been CE marked by the manufacturer at all;

(b)    has been CE marked by the manufacturer as a medical device or an accessory for a medical device;

(c)    has been CE marked by the manufacturer not as a medical device or an accessory for a medical device, but with reference to Directive 2006/42/EC ¹ on machinery?

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?

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?

Is it relevant for the answer to question 4 whether

(a)    the letter of formal notice from a competitor contains a clear indication of an infringement [of the law], that is to say, it is worded so specifically that the distributor can easily identify the infringement without a detailed examination of the law or the facts;

(b)    the distributor, upon making an enquiry, has been informed by the manufacturer or by a public authority that the objections set out in the letter of formal notice are unfounded?

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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).

¹     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).