ECLI:EU:C:2026:443

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JUDGMENT OF THE COURT (First Chamber)

4 June 2026 (*)

( Reference for a preliminary ruling – Medical devices – Regulation (EU) 2017/745 – CE marking of a medical device falling under risk class IIa – Oil-free dry air compressors for the production of compressed air for dental treatment – Making available on the market – Obligations of distributors – Verification of the classification as a ‘medical device’ where the manufacturer has affixed a CE marking to the device in question as ‘machinery’ )

In Case C‑10/24,

REQUEST for a preliminary ruling under Article 267 TFEU from the Bundesgerichtshof (Federal Court of Justice, Germany), made by decision of 21 December 2023, received at the Court on 9 January 2024, in the proceedings

Dürr Dental SE

Cattani Deutschland Helmes GmbH & Co. KG,

THE COURT (First Chamber),

composed of F. Biltgen, President of the Chamber, I. Ziemele, A. Kumin (Rapporteur), S. Gervasoni and M. Bošnjak, Judges,

Advocate General: D. Spielmann,

Registrar: A. Calot Escobar,

having regard to the written procedure,

after considering the observations submitted on behalf of:

– Dürr Dental SE, by C. Göttschkes, Rechtsanwalt,

– Cattani Deutschland Helmes GmbH & Co. KG, by C. Karle and M. Weidner, Rechtsanwälte,

– the Greek Government, by D. Kalogiros and V. Karra, acting as Agents,

– the Finnish Government, by A. Laine, acting as Agent,

– the European Commission, by M. Noll-Ehlers, M. Owsiany-Hornung and A. Spina, acting as Agents,

after hearing the Opinion of the Advocate General at the sitting on 11 September 2025,

gives the following

Judgment

1 This request for a preliminary ruling concerns the interpretation of Article 14(1), point (a) of the first subparagraph of Article 14(2) and the third subparagraph of Article 14(2) of 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 The request has been made in proceedings between Dürr Dental SE and Cattani Deutschland Helmes GmbH & Co. KG (‘Cattani Deutschland’) concerning the prohibition on making available on the market oil-free dry air compressors for the production of compressed air for dental treatment because they do not satisfy the requirements of Regulation 2017/745.

Legal context

European Union law

Directive 2006/42/EC

3 Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ 2006 L 157, p. 24), aims to harmonise the conditions in which machinery bearing the CE marking and accompanied by the EU declaration of conformity are placed on the internal market and to ensure their freedom of movement within the European Union, whilst guaranteeing compliance with a series of requirements intended to protect persons’ health and safety with respect to the risks arising out of the use of such machinery.

4 That directive was repealed by Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42 and Council Directive 73/361/EEC (OJ 2023 L 165, p. 1). However, pursuant to Article 51(2) of that regulation, that directive remains applicable until January 2027.

5 Article 3 of the same directive, headed ‘Specific Directives’, provides:

‘Where, for machinery, the hazards referred to in Annex I are wholly or partly covered more specifically by other Community Directives, this Directive shall not apply, or shall cease to apply, to that machinery in respect of such hazards from the date of implementation of those other Directives.’

Regulation 2017/745

6 Recital 2 of Regulation 2017/745 states that that regulation ‘aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small and medium-sized enterprises [(SMEs)] that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other’.

7 Under recital 27 of that regulation, ‘it is appropriate to set out clearly the general obligations of the different economic operators, including importers and distributors, building on the New Legislative Framework for the Marketing of Products … to enhance understanding of the requirements laid down in this Regulation and thus to improve regulatory compliance by the relevant operators’.

8 Article 2 of that regulation, headed ‘Definitions’, provides, in points 34, 43, 60 and 61 thereof:

‘For the purposes of this Regulation, the following definitions apply:

…

(34) “distributor” means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;

…

(43) “CE marking of conformity” or “CE marking” means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing;

…

(60) “post-market surveillance” means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;

(61) “market surveillance” means the activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection’.

9 Article 14 of Regulation 2017/745, entitled ‘General obligations of distributors’, provides, in paragraphs 1 and 2 thereof:

‘1. When making a device available on the market, distributors shall, in the context of their activities, act with due care in relation to the requirements applicable.

2. Before making a device available on the market, distributors shall verify that all of the following requirements are met:

(a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;

(b) the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);

(d) that, where applicable, a [Unique Device Identifier (UDI)] has been assigned by the manufacturer.

In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph the distributor may apply a sampling method that is representative of the devices supplied by that distributor.

Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer’s authorised representative, and the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which it is established.’

10 Article 16 of that regulation, headed ‘Cases in which obligations of manufacturers apply to importers, distributors or other persons’, provides, in paragraph 1 thereof:

‘A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:

(a) makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;

(b) changes the intended purpose of a device already placed on the market or put into service;

(c) modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.

…’

11 Article 19 of that regulation, headed ‘EU declaration of conformity’, provides, in paragraph 3 thereof:

‘By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance with the requirements of this Regulation and all other Union legislation applicable to the device.’

12 Article 51 of that regulation, headed ‘Classification of devices’, provides, in paragraphs 1 and 2 thereof:

‘1. Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII.

2. Any dispute between the manufacturer and the notified body concerned, arising from the application of Annex VIII, shall be referred for a decision to the competent authority of the Member State in which the manufacturer has its registered place of business. …’

German law

13 Paragraph 8 of the Gesetz gegen den unlauteren Wettbewerb (Law against unfair competition) of 3 July 2004 (BGBl. 2004 I, p. 1414), in the version applicable to the main proceedings, entitled ‘Cessation of conduct or injunctive relief’, provides:

‘(1) Any commercial practice which is prohibited under Paragraph 3 or Paragraph 7 may give rise to a claim seeking the cessation of the practice, and, if there is a risk of recurrence, a prohibitory injunction. …

…

(3) The injunctive relief referred to in subparagraph 1 may be claimed by:

1. any competitor who markets or requests goods or services in a non-negligible and non-occasional manner,

…’

The dispute in the main proceedings and the questions referred for a preliminary ruling

14 Dürr Dental manufactures compressors for the production of compressed air for dental treatment. In accordance with a decision of the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) (Federal Institute for Drugs and Medical Devices, Germany), those devices must be classified as medical devices falling under risk class IIa, within the meaning of Annex IX to Directive 93/42/ECC of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1), which was repealed and replaced by Regulation 2017/745.

15 As a legally independent German representative of Cattani SpA, established in Italy, Cattani Deutschland distributes, in Germany, what are known as ‘non-lubricated’ dry air compressors for the production of compressed air (‘the compressors at issue in the main proceedings’).

16 Dürr Dental purchased, as part of two test purchases, two compressors distributed by Cattani Deutschland, one in November 2020 and the other at the beginning of 2021. Both compressors bore a CE marking. However, the manufacturer’s EU declaration of conformity relating to them referred neither to Directive 93/42 nor to Regulation 2017/745, which apply to medical devices, but only to Directive 2006/42 on machinery. In addition, those two compressors did not bear a four-digit identification number of the notified body responsible for the conformity assessment procedure, such as that which must follow the CE marking of a risk class IIa medical device within the meaning of Directive 93/42 and Regulation 2017/745. Those compressors were accompanied by instructions for use for the manufacturer’s ‘non-lubricated dry air compressors 1-2-3 cylinders’.

17 On the basis of the information in the instructions for use and on the manufacturer’s website, Dürr Dental took the view that the compressors at issue in the main proceedings had to be regarded as accessories for risk class IIa medical devices, within the meaning of Regulation 2017/745. Those compressors should therefore have been CE marked in relation to medical devices and have borne a four-digit identification number of the notified body responsible for the conformity assessment procedure. In its view, it fell to Cattani Deutschland, as distributor, to verify and ensure compliance with the provisions of that regulation, which determine the lawfulness of marketing. Dürr Dental thus requested Cattani Deutschland, immediately following its first test purchase, to make a declaration to cease and desist, on pain of penalty (Unterlassungserklärung), in respect of those compressors.

18 However, Cattani Deutschland refused to make such a declaration. It considered that the distributor’s obligations under Regulation 2017/745 concerned a priori only products specifically placed on the market by the manufacturer as medical devices. After being informed by Dürr Dental of the allegedly incorrect nature of the CE marking that the compressors at issue in the main proceedings bore and after receiving formal notice from Dürr Dental in that regard, Cattani Deutschland contacted the manufacturer in Italy, which confirmed that the device concerned was not a medical device. Cattani Deutschland also contacted the BfArM, which concluded that the adoption of official measures was not necessary and that the device could remain on the market as it was.

19 On 10 March 2021, Dürr Dental brought an action before the Landgericht Stade (Regional Court, Stade, Germany) seeking an order prohibiting Cattani Deutschland, on pain of a periodic penalty payment, from making available on the market the compressors at issue in the main proceedings. In addition, Dürr Dental asked that court to declare that Cattani Deutschland is obliged to pay it damages, to provide it with information and to reimburse it the costs incurred in issuing the letter of formal notice, plus interest, as well as the costs of the first test purchase, plus interest.

20 On the date of the letter of formal notice and the date on which that action was brought, Directive 93/42 and the Gesetz über Medizinprodukte (Medizinproduktegesetz – MPG) (Law on medical devices) of 7 August 2002 (BGBl. 2002 I, p. 3146), transposing that directive into German law, was still in force. On 26 May 2021, Regulation 2017/745 entered into force.

21 The Landgericht Stade (Regional Court, Stade) upheld only the claim for reimbursement of the costs of the first test purchase and dismissed the action as to the remainder.

22 Hearing the case on appeal brought by Dürr Dental, the Oberlandesgericht Celle (Higher Regional Court, Celle, Germany) upheld that action, except in so far as it concerned the four-digit identification number of a notified body responsible for the conformity assessment procedure.

23 By its appeal on a point of law (Revision), brought before the Bundesgerichtshof (Federal Court of Justice, Germany), which is the referring court, Dürr Dental maintains its action in so far as it relates to the four-digit identification number of a notified body. By its cross-appeal on a point of law (Revision), Cattani Deutschland seeks, first, to have the judgment delivered by the Oberlandesgericht Celle (Higher Regional Court, Celle) set aside in part and, secondly, to have the claims made by Dürr Dental on appeal dismissed.

24 The referring court states that, at the time when Dürr Dental carried out the test purchases, the conduct alleged against Cattani Deutschland was not in conformity with the national legislation transposing Directive 93/42. Since a decision on the application for injunctive relief brought by Dürr Dental also requires that that conduct be assessed in the light of Regulation 2017/745, which repealed that directive with effect from 26 May 2021, the referring court is uncertain as to the interpretation of Article 14(1), point (a) of the first subparagraph of Article 14(2) and the third subparagraph of Article 14(2) of that regulation.

25 In those circumstances, the Bundesgerichtshof (Federal Court of Justice) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

‘(1) Is a distributor obliged under Article 14(1) and point (a) of the first subparagraph of Article 14(2) of Regulation [2017/745] 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:

(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] on machinery?

(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 [2017/745] also include verification of whether the device is to fall under risk class IIa within the meaning of Regulation [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 [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 [2017/745]?

(5) 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?’

Consideration of the questions referred

The first and second questions

26 By its first and second questions, which it is appropriate to examine together, the referring court asks, in essence, whether Article 14(1) and point (a) of the first subparagraph of Article 14(2) of Regulation 2017/745 must be interpreted as requiring the distributor to verify whether a product that it makes available on the market is to be regarded as a medical device, within the meaning of Regulation 2017/745, and whether the fact that the manufacturer has affixed a CE marking as ‘machinery’ within the meaning of Directive 2006/42 is relevant in that regard.

27 As a preliminary point, it should be noted that it is common ground that the compressors at issue in the main proceedings must be regarded as accessories to a medical device and, on that basis, as falling within the scope of Regulation 2017/745. Since that regulation is a specific act referred to in Article 3 of Directive 2006/42, that directive does not apply to those devices. Indeed, the referring court points out that it is clear from the manufacturer’s instructions for use that those compressors were intended to be used with a dental unit in the treatment of patients, that is to say, with a medical device, and therefore to fulfil a medical function.

28 It follows from settled case-law that, for the purpose of interpreting a provision of EU law, account must be taken not only of the wording of the provision in question, but also of the context in which it occurs, as well as the objectives pursued by the rules of which it forms part (judgments of 17 November 1983, Merck, 292/82, EU:C:1983:335, paragraph 12, and of 30 October 2025, Pome, C‑398/24, EU:C:2025:843, paragraph 23 and the case-law cited).

29 As regards the textual interpretation of Article 14(1) of Regulation 2017/745, it must be borne in mind that, under that provision, distributors must, when making a device available on the market, in the course of their activities, ‘act with due care in relation to the requirements applicable’. The first subparagraph of Article 14(2) of that regulation states that, before making a device available on the market, distributors must, inter alia, verify that it has been CE marked and that the EU declaration of conformity of the device has been drawn up (point (a) of the first subparagraph of Article 14(2) of Regulation 2017/745), that the device is accompanied by the necessary information (point (b) of the first subparagraph of Article 14(2) of that regulation), that the importer has complied with the requirements applicable to it (point (c) of the first subparagraph of Article 14(2) of that regulation) and that, where applicable, a Unique Device Identification system (UDI system) has been applied by the manufacturer (point (d) of the first subparagraph of Article 14(2) of that regulation), as described in Part C of Annex VI thereto, allowing the identification and facilitating the traceability of devices other than custom-made devices and investigational devices.

30 It is apparent from the wording of the latter provision, which sets out specific obligations incumbent on the distributor, that it is for the distributor to verify the existence of the CE marking and the EU declaration of conformity, relating to the device in question, but not the accuracy thereof.

31 In the context of the contextual interpretation, it should be noted that, in accordance with Article 2(43) of Regulation 2017/745, the manufacturer must indicate, by means of the CE marking, that a device is in conformity with the applicable requirements set out in that regulation and other EU harmonisation legislation providing for its affixing. Under Article 10(1) and (6) of Regulation 2017/745, the manufacturer must, when placing a device on the market or putting it into service, ensure that it has been designed and manufactured in accordance with the requirements of that regulation, then, in principle, where compliance with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, draw up an EU declaration of conformity as provided for in Article 19 of that regulation and affix the CE marking of conformity referred to in Article 20 of that regulation. Furthermore, Article 16 of Regulation 2017/745 assigns the manufacturer’s obligations to the distributor only in very specific situations, which it lists exhaustively, to which the situation in the main proceedings does not correspond.

32 Those rules reflect the fact that it is the manufacturer who has precise knowledge of the design, operation and intended purpose of its product and is therefore best placed to determine which rules apply to it. Consequently, the obligation to verify the conformity of a device with the applicable legislation falls, in principle, within the manufacturer’s responsibility and not that of the distributor.

33 However, the third subparagraph of Article 14(2) of Regulation 2017/745 provides that, ‘where a distributor considers or has reason to believe that a device is not in conformity with the requirements this Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer’s authorised representative, and the importer’.

34 It follows from that provision that, as the Advocate General noted in point 53 of his Opinion, before making the device available on the market, the distributor of that device must notify the relevant operators if it is aware of a problem in connection with the conformity of that device with Regulation 2017/745.

35 A misclassification of the product at issue by the manufacturer may mean that that product is not in conformity with the applicable legislation. If, as in the dispute in the main proceedings, a product, instead of being correctly classified as an ‘accessory for a medical device’, is classified as ‘machinery’, the legislation on machinery, which is applied by the manufacturer, is not relevant, in accordance with Article 3 of the Directive 2006/42. In a case of misclassification by the manufacturer, the rules applicable in relation to medical devices could therefore be infringed when a product is made available on the market, because the CE marking and the EU declaration of conformity are for machinery rather than for a medical device, within the meaning of Regulation 2017/745.

36 Therefore, it follows from the third subparagraph of Article 14(2) of Regulation 2017/745 that a distributor who has reason to believe that a device is not in conformity with that regulation may be required to react before that device is made available on the market, even if it is not responsible for the conformity of that product with the applicable rules.

37 In the light of its wording and the context in which it occurs, the first subparagraph of Article 14(2) of Regulation 2017/745 cannot be interpreted as requiring the distributor to verify the classification of each product and, consequently, to repeat systematically the conformity assessment carried out by the manufacturer. However, the distributor’s obligation to act with ‘due care’, within the meaning of Article 14(1) of that regulation, read in conjunction with the third subparagraph of Article 14(2), requires, before the device concerned is made available on the market, that the distributor exercise vigilance in the form, inter alia, of a verification ‘of consistency’, based on the documents at the distributor’s disposal or that are accessible to it.

38 In that regard, the documents that the distributor must have, in particular the EU declaration of conformity, the CE marking of the product and the instructions for use, constitute documents enabling the distributor to carry out the necessary checks. For example, in the situation mentioned by the referring court in its second question, in which a device has been CE marked by the manufacturer and that marking corresponds to different legislation, in the present case Directive 2006/42, the EU declaration of conformity may enable a clear inconsistency to be identified in that regard, in particular if the intended medical purpose of the product concerned is apparent or there can be no doubt that it is a medical device or an accessory for a medical device. Similarly, as the referring court states, useful information on the scope of the products at issue may appear on the manufacturer’s website and, as the Finnish Government has pointed out, promotional material may also contain relevant information.

39 That information, which is easily accessible, makes it possible for the court having jurisdiction to assess whether or not the distributor has exercised the requisite due care. Furthermore, infringement of the obligation to act with due care may be found only where the classification error is clear.

40 That contextual interpretation is borne out by the objectives pursued by Regulation 2017/745.

41 The legislative history of that regulation shows, in particular, the intention of the EU legislature to clarify the obligations incumbent on the various economic operators.

42 In that regard, it must be borne in mind that Regulation 2017/745 was adopted on the basis of Article 114 TFEU, on the approximation of laws relating to the establishment and functioning of the internal market, and on that of point (c) of the first subparagraph of Article 168(4) TFEU, on the approximation of laws and the protection of public health through measures setting high standards of quality and safety for medical devices.

43 By choosing that legal basis, the EU legislature wished, inter alia, to align the legislation governing medical devices with the new legislative framework applicable to the marketing of products, in particular Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ 2008 L 218, p. 82), which provides, in particular, for the common framework of general principles and reference provisions for the preparation of Community legislation harmonising the conditions for the marketing of products within the European Union. Annex I to that decision, headed ‘Reference provisions for Community harmonisation legislation for products’, includes Chapter R2 thereof, which contains the provisions relating to the obligations of economic operators.

44 Thus, according to recital 27 of Regulation 2017/745, ‘it is appropriate to set out clearly the general obligations of the different economic operators, including importers and distributors, building on the New Legislative Framework for the Marketing of Products, without prejudice to the specific obligations laid down in the various parts of this Regulation, to enhance understanding of the requirements laid down in this Regulation and thus to improve regulatory compliance by the relevant operators’.

45 It is also apparent from recital 2 of that regulation that it ‘aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the [SMEs] that are active in this sector’ and that ‘at the same time, this Regulation sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products’, it being specified that ‘both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other’.

46 The interpretation that the distributor is subject to an obligation to carry out a ‘verification of consistency’, as is apparent from the considerations set out in paragraphs 37 to 39 above, is such as to contribute to the attainment of both objectives of Regulation 2017/745.

47 Furthermore, as the Advocate General observed, in essence, in points 68 and 69 of his Opinion, first, there is nothing to suggest that the existence of such a monitoring obligation would entail significant disadvantages for distributors who are SMEs active in that sector. Such an interpretation is also consistent with the obligation on all economic operators ‘to act responsibly’ within the meaning of recital 18 of Decision No 768/2008.

48 Secondly, both objectives would be undermined if a medical device that is manifestly not in conformity with the applicable legislation were nevertheless automatically made available on the market by the distributor, without the distributor being required, by virtue of its obligation to act with due care, to carry out the necessary checks in order to detect that irregularity.

49 It should be noted in that context that the due care that may be exercised by the distributor, such as, in the present case, that exercised by Cattani Deutschland, to which reference is made in paragraph 18 above, may enable it to show that it has fulfilled its obligations in that regard, including, as the case may be, having regard to its contractual relationship with the manufacturer, which will be, however, a matter for the referring court to assess.

50 Contrary to what Cattani Deutschland maintains, according to such an approach, responsibility for the conformity of products does not lie with the distributor. Indeed, since the distributor’s obligations arise from the obligation to act with due care, within the meaning of Article 14(1) and (2) of Regulation 2017/745, the question of the extent to which the distributor has an obligation to verify, where appropriate, the manifestly incorrect nature of the CE marking to be affixed by the manufacturer forms part of the case-by-case interpretation of that provision and is independent from the responsibility for the conformity of products with that regulation that is borne by the manufacturer. It will therefore be for the referring court to assess, in the light of all the circumstances of the case, having regard to the basic knowledge expected of a distributor of medical devices, to the content of the documents accessible to it and to the technical difficulty of the present case, whether the efforts made by the distributor were sufficient in the light of its obligation to act with due care, within the meaning of Article 14(1) of Regulation 2017/745.

51 In the light of all the foregoing considerations, the answer to the first and second questions is that Article 14(1) and point (a) of the first subparagraph of Article 14(2) of Regulation 2017/745 must be interpreted as meaning that, as part of its obligation to act with due care, a distributor must verify, in the light of the information at its disposal, whether the CE marking and the EU declaration of conformity for the product that it makes available on the market clearly concern a device falling within the scope of that regulation.

The third question

52 By its third question, the referring court asks, in essence, whether point (a) of the first subparagraph of Article 14(2), read in conjunction with Article 14(1), of Regulation 2017/745 must be interpreted as meaning that a distributor is required to verify whether the device that it makes available on the market must be classified in risk class IIa, within the meaning of that regulation, and, therefore, whether that device must bear a four-digit identification number of a notified body.

53 It should be borne in mind, as a preliminary point, that it is apparent, in particular, from Article 10(6) and Articles 51 to 53 of Regulation 2017/745 that it is not for the distributor but for the manufacturer to determine the class of its device in order to know the applicable requirements. Under Article 51(1) of that regulation, ‘devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks’ and ‘classification shall be carried out in accordance with Annex VIII [thereto]’. Identifying the class of the device concerned enables the manufacturer to determine, in accordance with Article 52 of that regulation, the conformity assessment procedure to be applied, that is to say, the path to be taken in order to meet the applicable requirements and thus to be able to demonstrate the conformity of that device with that regulation.

54 In that context, it is important to note that some class I devices may be self-certified by the manufacturer, whereas, in accordance with Articles 52 and 53 of Regulation 2017/745, the other classes of devices require the involvement of a notified body, which has the task of assessing the conformity of the medical devices prior to any product being made available on the market and to ensure the continued compliance with the requirements throughout the process of making them available. Where a notified body is involved in the certification of the risk class of a device, the CE marking is, pursuant to Article 20(5) of that regulation, to be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 52 of that regulation. In addition, that identification number is to be indicated in any promotional material that mentions that a device fulfils the requirements for CE marking.

55 In the light of the considerations set out in paragraphs 27 to 50 above as regards the first and second questions, to require the distributor to verify the accuracy of the classification of that product in a risk class and, consequently, the need for a four-digit identification number of a notified body would exceed the distributor’s obligation to carry out a verification of consistency in accordance with their obligation to act with due care.

56 First, as recalled in paragraphs 53 and 54 above, it is for the manufacturer to classify a medical device, within the meaning of Regulation 2017/745, since such classification presupposes precise knowledge of the design, operation and intended purpose of that device, which, usually, only the manufacturer is in a position to possess.

57 Secondly, the fact that a notified body must be involved in the conformity assessment procedure depending on the risk class demonstrates the complexity of that classification process. Such a body is, moreover, subject to numerous requirements, in accordance with Article 36 of Regulation 2017/745, entitled ‘Requirements relating to notified bodies’, and Annex VII to that regulation, entitled ‘Requirements to be met by notified bodies’. It must, in particular, in accordance with the second subparagraph of Article 36(1) of that regulation, have permanent availability of sufficient administrative, technical and scientific personnel and all equipment, facilities and competence needed to perform properly the technical, scientific and administrative tasks entailed in the conformity assessment activities in relation to which it has been designated. In the event of disagreement between the manufacturer and the notified body about the correct classification of a device, Article 51(2) of that regulation provides that the dispute is to be referred for a decision to the competent authority of the Member State in which the manufacturer has its registered place of business, a decision that the distributor cannot call into question.

58 Therefore, as the Advocate General observed in point 80 of his Opinion, requiring a distributor to verify the accuracy of the classification of a medical device would significantly extend its obligations arising from the wording of Regulation 2017/745.

59 Furthermore, thirdly, such a verification obligation would run counter to the objectives of Regulation 2017/745. On the one hand, recital 27 of that regulation states that it is appropriate to set out clearly the general obligations of the different economic operators. That enables the operators concerned better to understand the requirements of that regulation and to comply with them more easily. That verification obligation imposed on the distributor could therefore blur the lines between the obligations of the various economic operators, in breach of the objective of clarity and, consequently, of the objective of legal certainty as regards those obligations.

60 On the other hand, it should be noted that the distributor is not necessarily in a position to verify the accuracy of the classification of a product, in particular in the case of an SME.

61 Such verification by the distributor of the accuracy of the classification of a medical device could therefore prove overly complex and could even, as the case may be, undermine the objective of safety and health protection for patients and users, given that the distributor does not possess the same competences, for that purpose, as the notified bodies.

62 Nevertheless, as the European Commission correctly pointed out, in the specific situation where it is apparent from the information available to the distributor that a device was classified by the manufacturer necessarily entailing the involvement of a notified body (class IIa, class IIb or class III), that distributor’s obligation to act with due care under Article 14(1) of Regulation 2017/745 means that it must verify that the CE marking is, as provided for in Article 20(5) of that regulation, followed by the identification number of that body. Such a formal verification may be carried out in the context of the verification of the CE marking, as provided for in point (a) of the first subparagraph of Article 14(2) of that regulation.

63 With the exception of that specific situation, an interpretation that consists in requiring distributors, as part of their obligation to act with due care laid down in Article 14, to verify the accuracy of the classification of medical devices would be contrary to the scheme of Regulation 2017/745.

64 Such an interpretation would not make it impossible to bring any action against non-compliant devices being made available on the market, contrary to the submission of Dürr Dental, which cites in that regard the example of a manufacturer that classifies its device in Class I in order to spare itself the involvement of a notified body. However, in the event of incorrect classification, the manufacturer’s responsibility cannot be imputed to the distributor for that reason.

65 It should be possible to hold the manufacturer of an incorrectly classified device liable for that misclassification, in accordance with the legal remedies provided for in national law, in compliance with the principles of equivalence and effectiveness. In addition, post-market surveillance, within the meaning of Article 2(60) of Regulation 2017/745, and market surveillance, within the meaning of Article 2(61) thereof, do not fall in the first instance to the distributor, even if it may be called upon, as an economic operator, to cooperate or to issue an alert in the event of a clearly incorrect classification.

66 In the light of all the foregoing considerations, the answer to the third question is that point (a) of the first subparagraph of Article 14(2) of Regulation 2017/745, read in conjunction with Article 14(1) thereof, must be interpreted as meaning that a distributor is not obliged to verify whether the device it makes available on the market must be classified in risk class IIa, within the meaning of that regulation. However, if the information available to that distributor indicates that that device is classified by the manufacturer in a risk class necessarily entailing the involvement of a notified body, the distributor’s obligation to act with due care includes verification that the four-digit identification number of that body is indicated.

The fourth and fifth questions

67 By its fourth and fifth questions, which it is appropriate to examine together, the referring court asks, in essence, whether the third subparagraph of Article 14(2) of Regulation 2017/745 must be interpreted as meaning that a distributor has reason to believe that a product is not in conformity with Regulation 2017/745 where a letter of formal notice has been sent to it by a competitor concerning the non-compliance of that product and the manufacturer and a public authority subsequently inform it that the alleged non-compliance is unfounded.

68 It should be noted that the third subparagraph of Article 14(2) of Regulation 2017/745 provides that, where a distributor considers or has reason to believe that a device is not in conformity with the requirements of that regulation, it is not to make the device available on the market until it has been brought into conformity, and is to inform the manufacturer and, where applicable, the manufacturer’s authorised representative, and the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it is also to inform the competent authority of the Member State in which it is established.

69 As stated in paragraph 37 above, Article 14(1) of that regulation, read in conjunction with the third subparagraph of Article 14(2) thereof, imposes on the distributor an obligation to act with due care that requires, before the device concerned is made available on the market, that the distributor exercise vigilance that may result in a verification of consistency, based on the documents at the distributor’s disposal or that are accessible to it.

70 In that regard, even if the device has already been made available on the market, the letter of formal notice sent by a competitor, which sets out the reasons in fact and in law why the product concerned is not in conformity with Regulation 2017/745, must be taken into account by the distributor in order to exercise its obligation to act with due care. However, it is for the latter to assess, under its responsibility, whether that formal notice provides it with reasons to believe that the product at issue is not in conformity with Regulation 2017/745 and, where appropriate, to draw the appropriate conclusions.

71 Similarly, if the distributor informs the manufacturer of its reasons for believing that the product concerned by the letter of formal notice is non-compliant and if the manufacturer is of the opinion that the alleged non-compliance is unfounded, the distributor is not obliged to follow that opinion if its doubts concerning that non-compliance persist. Nevertheless, since responsibility for the conformity of the products lies with the manufacturer and not with the distributor, as has been pointed out in paragraph 50 above, the latter cannot be criticised for having failed to fulfil its obligation to act with due care by following the opinion issued by the manufacturer, unless that opinion appears to it to be manifestly unfounded.

72 Lastly, where the distributor has informed the competent national authority, pursuant to the third subparagraph of Article 14(2) of Regulation 2017/745, the doubts as to the conformity of the product concerned that led it to inform the national authority are dispelled without reservation by the reasoned and clear opinion of that authority refuting the alleged non-compliance.

73 In the light of all the foregoing considerations, the answer to the fourth and fifth questions is that the third subparagraph of Article 14(2) of Regulation 2017/745 must be interpreted as meaning that a distributor may have reason to believe that a product is not in conformity with Regulation 2017/745 where a letter of formal notice has been sent to it by a competitor concerning the non-compliance of that product. If the manufacturer, when questioned by the distributor, is of the opinion that the alleged non-compliance is unfounded, the distributor cannot be held to have breached its obligations under that provision by following the opinion issued by the manufacturer, unless that opinion appears to the distributor to be manifestly unfounded. Where the distributor has informed the competent national authority pursuant to that provision, the doubts thus expressed as to the conformity of the product concerned are dispelled without reservation by the reasoned and clear opinion of that authority refuting the alleged non-compliance.

Costs

74 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.

On those grounds, the Court (First Chamber) hereby rules:

(1) Article 14(1) and point (a) of the first subparagraph of Article 14(2) of 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,

must be interpreted as meaning that, as part of its obligation to act with due care, a distributor must verify, in the light of the information at its disposal, whether the CE marking and the EU declaration of conformity for the product that it makes available on the market clearly concern a device falling within the scope of that regulation.

(2) Point (a) of the first subparagraph of Article 14(2) of Regulation 2017/745, read in conjunction with Article 14(1) thereof,

must be interpreted as meaning that a distributor is not obliged to verify whether the device it makes available on the market must be classified in risk class IIa, within the meaning of that regulation. However, if the information available to that distributor indicates that that device is classified by the manufacturer in a risk class necessarily entailing the involvement of a notified body, the distributor’s obligation to act with due care includes verification that the four-digit identification number of that body is indicated.

(3) The third subparagraph of Article 14(2) of Regulation 2017/745

must be interpreted as meaning that a distributor may have reason to believe that a product is not in conformity with Regulation 2017/745 where a letter of formal notice has been sent to it by a competitor concerning the non-compliance of that product. If the manufacturer, when questioned by the distributor, is of the opinion that the alleged non-compliance is unfounded, the distributor cannot be held to have breached its obligations under that provision by following the opinion issued by the manufacturer, unless that opinion appears to the distributor to be manifestly unfounded. Where the distributor has informed the competent national authority pursuant to that provision, the doubts thus expressed as to the conformity of the product concerned are dispelled without reservation by the reasoned and clear opinion of that authority refuting the alleged non-compliance.

[Signatures]

* Language of the case: German.

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