{"attribution":{"source":"legal.exploreworldai.com","canonical":"https://legal.exploreworldai.com/api/public/v1/judgment-text?id=eu:c-10-24","cite_as":"NovaCopilot, legal.exploreworldai.com (https://legal.exploreworldai.com/api/public/v1/judgment-text?id=eu:c-10-24)","license":"https://legal.exploreworldai.com/revision","version":"legal-2026-10-27","fingerprint":"ewai:eu:66a2b7","proof":"sha256:201ce43f80b9b76c279cd5ed298dfa3679cdf09420b056627a6d81a1aa735601","jurisdiction":"eu","lang":"en","publisher":"NovaCopilot by ExploreWorld Legal","terms":"https://legal.exploreworldai.com/om"},"brand_source":"Source: NovaCopilot","item":{"schema_version":"1.0.0","id":"eu:c-10-24","jurisdiction":"eu","lang":"en","brand_source":"Source: NovaCopilot","brand":{"product":"NovaCopilot","platform":"ExploreWorldAI","infrastructure":"ExploreWorld Legal","infrastructure_url":"legal.exploreworldai.com","legal_entity":"Valkiv Ventures AB","permanent_url":"https://legal.exploreworldai.com/novacopilot","source":"Source: NovaCopilot","powered_by":"Powered by NovaCopilot","license":"https://legal.exploreworldai.com/licensvillkor"},"sections":[{"title":"Front matter","paragraphs":["para_1","para_2","para_3","para_4","para_5","para_6","para_7","para_8","para_9","para_10","para_11","para_12","para_13","para_14","para_15","para_16","para_17","para_18","para_19","para_20","para_21","para_22"],"kind":"front_matter"},{"title":"Judgment","paragraphs":["para_23","para_24","para_25"],"kind":"assessment"},{"title":"Legal context","paragraphs":["para_26"],"kind":"legal_framework"},{"title":"European Union law","paragraphs":["para_27"],"kind":"legal_framework"},{"title":"Directive 2006/42/EC","paragraphs":["para_28","para_29","para_30","para_31","para_32"],"kind":"legal_framework"},{"title":"Regulation 2017/745","paragraphs":["para_33","para_34","para_35","para_36","para_37","para_38","para_39","para_40","para_41","para_42","para_43","para_44","para_45","para_46","para_47","para_48","para_49","para_50","para_51","para_52","para_53","para_54","para_55","para_56","para_57","para_58","para_59","para_60","para_61","para_62","para_63","para_64"],"kind":"legal_framework"},{"title":"German law","paragraphs":["para_65","para_66","para_67","para_68","para_69","para_70","para_71"],"kind":"legal_framework"},{"title":"The dispute in the main proceedings and the questions referred for a preliminary ruling","paragraphs":["para_72","para_73","para_74","para_75","para_76","para_77","para_78","para_79","para_80","para_81","para_82","para_83","para_84","para_85","para_86","para_87","para_88","para_89","para_90","para_91","para_92","para_93","para_94"],"kind":"facts"},{"title":"Consideration of the questions referred","paragraphs":["para_95"],"kind":"questions"},{"title":"The first and second questions","paragraphs":["para_96","para_97","para_98","para_99","para_100","para_101","para_102","para_103","para_104","para_105","para_106","para_107","para_108","para_109","para_110","para_111","para_112","para_113","para_114","para_115","para_116","para_117","para_118","para_119","para_120","para_121","para_122"],"kind":"questions"},{"title":"The third question","paragraphs":["para_123","para_124","para_125","para_126","para_127","para_128","para_129","para_130","para_131","para_132","para_133","para_134","para_135","para_136","para_137","para_138"],"kind":"assessment"},{"title":"The fourth and fifth questions","paragraphs":["para_139","para_140","para_141","para_142","para_143","para_144","para_145","para_146"],"kind":"assessment"},{"title":"Costs","paragraphs":["para_147","para_148"],"kind":"costs"},{"title":"On those grounds, the Court (First Chamber) hereby rules:","paragraphs":["para_149","para_150","para_151","para_152","para_153","para_154","para_155","para_156","para_157"],"kind":"operative"}],"paragraphs":[{"text":"Provisional text","paragraph_id":"para_1"},{"text":"JUDGMENT OF THE COURT (First Chamber)","paragraph_id":"para_2"},{"text":"4 June 2026 ( * )","paragraph_id":"para_3"},{"text":"( 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’ )","paragraph_id":"para_4"},{"text":"In Case C‑10/24,","paragraph_id":"para_5"},{"text":"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","paragraph_id":"para_6"},{"text":"Dürr Dental SE","paragraph_id":"para_7"},{"text":"v","paragraph_id":"para_8"},{"text":"Cattani Deutschland Helmes GmbH & Co. KG,","paragraph_id":"para_9"},{"text":"THE COURT (First Chamber),","paragraph_id":"para_10"},{"text":"composed of F. Biltgen, President of the Chamber, I. Ziemele, A. Kumin (Rapporteur), S. Gervasoni and M. Bošnjak, Judges,","paragraph_id":"para_11"},{"text":"Advocate General: D. Spielmann,","paragraph_id":"para_12"},{"text":"Registrar: A. Calot Escobar,","paragraph_id":"para_13"},{"text":"having regard to the written procedure,","paragraph_id":"para_14"},{"text":"after considering the observations submitted on behalf of:","paragraph_id":"para_15"},{"text":"–        Dürr Dental SE, by C. Göttschkes, Rechtsanwalt,","paragraph_id":"para_16"},{"text":"–        Cattani Deutschland Helmes GmbH & Co. KG, by C. Karle and M. Weidner, Rechtsanwälte,","paragraph_id":"para_17"},{"text":"–        the Greek Government, by D. Kalogiros and V. Karra, acting as Agents,","paragraph_id":"para_18"},{"text":"–        the Finnish Government, by A. Laine, acting as Agent,","paragraph_id":"para_19"},{"text":"–        the European Commission, by M. Noll-Ehlers, M. Owsiany-Hornung and A. Spina, acting as Agents,","paragraph_id":"para_20"},{"text":"after hearing the Opinion of the Advocate General at the sitting on 11 September 2025,","paragraph_id":"para_21"},{"text":"gives the following","paragraph_id":"para_22"},{"text":"Judgment","paragraph_id":"para_23"},{"text":"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).","paragraph_id":"para_24"},{"text":"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.","paragraph_id":"para_25"},{"text":"Legal context","paragraph_id":"para_26"},{"text":"European Union law","paragraph_id":"para_27"},{"text":"Directive 2006/42/EC","paragraph_id":"para_28"},{"text":"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 …","paragraph_id":"para_29"},{"text":"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.","paragraph_id":"para_30"},{"text":"5         Article 3 of the same directive, headed ‘Specific Directives’, provides:","paragraph_id":"para_31"},{"text":"‘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.’","paragraph_id":"para_32"},{"text":"Regulation 2017/745","paragraph_id":"para_33"},{"text":"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 enterprise …","paragraph_id":"para_34"},{"text":"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’.","paragraph_id":"para_35"},{"text":"8         Article 2 of that regulation, headed ‘Definitions’, provides, in points 34, 43, 60 and 61 thereof:","paragraph_id":"para_36"},{"text":"‘For the purposes of this Regulation, the following definitions apply:","paragraph_id":"para_37"},{"text":"…","paragraph_id":"para_38"},{"text":"(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;","paragraph_id":"para_39"},{"text":"…","paragraph_id":"para_40"},{"text":"(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;","paragraph_id":"para_41"},{"text":"…","paragraph_id":"para_42"},{"text":"(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;","paragraph_id":"para_43"},{"text":"(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’.","paragraph_id":"para_44"},{"text":"9         Article 14 of Regulation 2017/745, entitled ‘General obligations of distributors’, provides, in paragraphs 1 and 2 thereof:","paragraph_id":"para_45"},{"text":"‘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.","paragraph_id":"para_46"},{"text":"2.      Before making a device available on the market, distributors shall verify that all of the following requirements are met:","paragraph_id":"para_47"},{"text":"(a)      the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;","paragraph_id":"para_48"},{"text":"(b)      the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);","paragraph_id":"para_49"},{"text":"(c)      for imported devices, the importer has complied with the requirements set out in Article 13(3);","paragraph_id":"para_50"},{"text":"(d)      that, where applicable, a [Unique Device Identifier (UDI)] has been assigned by the manufacturer.","paragraph_id":"para_51"},{"text":"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.","paragraph_id":"para_52"},{"text":"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 manufacture …","paragraph_id":"para_53"},{"text":"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:","paragraph_id":"para_54"},{"text":"‘A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:","paragraph_id":"para_55"},{"text":"(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;","paragraph_id":"para_56"},{"text":"(b)      changes the intended purpose of a device already placed on the market or put into service;","paragraph_id":"para_57"},{"text":"(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.","paragraph_id":"para_58"},{"text":"…’","paragraph_id":"para_59"},{"text":"11       Article 19 of that regulation, headed ‘EU declaration of conformity’, provides, in paragraph 3 thereof:","paragraph_id":"para_60"},{"text":"‘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.’","paragraph_id":"para_61"},{"text":"12       Article 51 of that regulation, headed ‘Classification of devices’, provides, in paragraphs 1 and 2 thereof:","paragraph_id":"para_62"},{"text":"‘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.","paragraph_id":"para_63"},{"text":"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. …’","paragraph_id":"para_64"},{"text":"German law","paragraph_id":"para_65"},{"text":"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:","paragraph_id":"para_66"},{"text":"‘(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. …","paragraph_id":"para_67"},{"text":"…","paragraph_id":"para_68"},{"text":"(3)      The injunctive relief referred to in subparagraph 1 may be claimed by:","paragraph_id":"para_69"},{"text":"1.      any competitor who markets or requests goods or services in a non-negligible and non-occasional manner,","paragraph_id":"para_70"},{"text":"…’","paragraph_id":"para_71"},{"text":"The dispute in the main proceedings and the questions referred for a preliminary ruling","paragraph_id":"para_72"},{"text":"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 me …","paragraph_id":"para_73"},{"text":"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’).","paragraph_id":"para_74"},{"text":"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 neith …","paragraph_id":"para_75"},{"text":"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. Tho …","paragraph_id":"para_76"},{"text":"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 a …","paragraph_id":"para_77"},{"text":"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 add …","paragraph_id":"para_78"},{"text":"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.","paragraph_id":"para_79"},{"text":"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.","paragraph_id":"para_80"},{"text":"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.","paragraph_id":"para_81"},{"text":"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 …","paragraph_id":"para_82"},{"text":"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 …","paragraph_id":"para_83"},{"text":"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:","paragraph_id":"para_84"},{"text":"‘(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?","paragraph_id":"para_85"},{"text":"(2)      Is it relevant for the answer to question 1 whether the product:","paragraph_id":"para_86"},{"text":"(a)      has been CE marked by the manufacturer at all;","paragraph_id":"para_87"},{"text":"(b)      has been CE marked by the manufacturer as a medical device or an accessory for a medical device;","paragraph_id":"para_88"},{"text":"(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?","paragraph_id":"para_89"},{"text":"(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?","paragraph_id":"para_90"},{"text":"(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 …","paragraph_id":"para_91"},{"text":"(5)      Is it relevant for the answer to question 4 whether:","paragraph_id":"para_92"},{"text":"(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;","paragraph_id":"para_93"},{"text":"(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?’","paragraph_id":"para_94"},{"text":"Consideration of the questions referred","paragraph_id":"para_95"},{"text":"The first and second questions","paragraph_id":"para_96"},{"text":"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 pr …","paragraph_id":"para_97"},{"text":"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 refer …","paragraph_id":"para_98"},{"text":"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).","paragraph_id":"para_99"},{"text":"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 applicab …","paragraph_id":"para_100"},{"text":"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.","paragraph_id":"para_101"},{"text":"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 …","paragraph_id":"para_102"},{"text":"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.","paragraph_id":"para_103"},{"text":"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’.","paragraph_id":"para_104"},{"text":"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.","paragraph_id":"para_105"},{"text":"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 classif …","paragraph_id":"para_106"},{"text":"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.","paragraph_id":"para_107"},{"text":"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 assessmen …","paragraph_id":"para_108"},{"text":"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 …","paragraph_id":"para_109"},{"text":"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.","paragraph_id":"para_110"},{"text":"40       That contextual interpretation is borne out by the objectives pursued by Regulation 2017/745.","paragraph_id":"para_111"},{"text":"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.","paragraph_id":"para_112"},{"text":"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.","paragraph_id":"para_113"},{"text":"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 2 …","paragraph_id":"para_114"},{"text":"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 sp …","paragraph_id":"para_115"},{"text":"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 se …","paragraph_id":"para_116"},{"text":"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.","paragraph_id":"para_117"},{"text":"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.","paragraph_id":"para_118"},{"text":"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.","paragraph_id":"para_119"},{"text":"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.","paragraph_id":"para_120"},{"text":"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 …","paragraph_id":"para_121"},{"text":"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 distrib …","paragraph_id":"para_122"},{"text":"The third question","paragraph_id":"para_123"},{"text":"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 …","paragraph_id":"para_124"},{"text":"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 requiremen …","paragraph_id":"para_125"},{"text":"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 c …","paragraph_id":"para_126"},{"text":"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.","paragraph_id":"para_127"},{"text":"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.","paragraph_id":"para_128"},{"text":"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 201 …","paragraph_id":"para_129"},{"text":"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.","paragraph_id":"para_130"},{"text":"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 oper …","paragraph_id":"para_131"},{"text":"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.","paragraph_id":"para_132"},{"text":"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.","paragraph_id":"para_133"},{"text":"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 …","paragraph_id":"para_134"},{"text":"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.","paragraph_id":"para_135"},{"text":"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 spa …","paragraph_id":"para_136"},{"text":"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 …","paragraph_id":"para_137"},{"text":"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 …","paragraph_id":"para_138"},{"text":"The fourth and fifth questions","paragraph_id":"para_139"},{"text":"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 confo …","paragraph_id":"para_140"},{"text":"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 unti …","paragraph_id":"para_141"},{"text":"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.","paragraph_id":"para_142"},{"text":"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 distri …","paragraph_id":"para_143"},{"text":"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 tha …","paragraph_id":"para_144"},{"text":"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.","paragraph_id":"para_145"},{"text":"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 Regulat …","paragraph_id":"para_146"},{"text":"Costs","paragraph_id":"para_147"},{"text":"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.","paragraph_id":"para_148"},{"text":"On those grounds, the Court (First Chamber) hereby rules:","paragraph_id":"para_149"},{"text":"(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,","paragraph_id":"para_150"},{"text":"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.","paragraph_id":"para_151"},{"text":"(2)        Point (a) of the first subparagraph of Article 14(2) of Regulation 2017/745, read in conjunction with Article 14(1) thereof,","paragraph_id":"para_152"},{"text":"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 classifi …","paragraph_id":"para_153"},{"text":"(3)        The third subparagraph of Article 14(2) of Regulation 2017/745","paragraph_id":"para_154"},{"text":"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. 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