Provisional text
OPINION OF ADVOCATE GENERAL
SPIELMANN
delivered on 11 September 2025 (1)
Case C‑10/24
Dürr Dental SE
v
Cattani Deutschland Helmes GmbH & Co. KG
(Request for a preliminary ruling from the Bundesgerichtshof (Federal Court of Justice, Germany))
( Reference for a preliminary ruling – Medical devices – 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 made by the manufacturer – CE marking of a risk class
IIa medical device within the meaning of Regulation (EU)
2017/745 )
Introduction
1.        What is the scope of the respective obligations of the distributors and the manufacturers of medical devices and, more specifically, what is the scope of the checks to be carried out by the distributors before making a medical device available on the market? That is the question that is essentially raised in the present case, which thus offers the Court the opportunity to interpret, for the first time, Article 14 of Regulation (EU) 2017/745 (2) on the general obligations of distributors of medical devices.
2.        That request has been made by the Bundesgerichtshof (Federal Court of Justice, Germany) in proceedings between Dürr Dental SE, as the applicant in the main proceedings, and Cattani Deutschland Helmes GmbH & Co. KG (‘Cattani’), as the defendant in the main proceedings, 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.
3.        The referring court is asking, in essence, about the verification obligations on distributors as regards the conformity with Regulation 2017/745 of the devices which they make available on the market (first, second and third questions referred for a preliminary ruling), and about the factors to be taken into consideration to determine whether a distributor has reason to believe that a device is not in conformity with that regulation (fourth and fifth questions referred for a preliminary ruling).
Legal context
European Union law
Regulation 2017/745
4.        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 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’.
5.        Recital 27 of Regulation 2017/745 provides that ‘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’.
6.        Point 34 of Article 2 of that regulation defines a ‘distributor’ as ‘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 it into service’.
7.        Article 14 of Regulation 2017/745, entitled ‘General obligations of distributors’, provides as follows:
‘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);
(c)      for imported devices, the importer has complied with the requirements set out in Article 13(3);
(d)      that, where applicable, a 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.
…’
8.        Article 51 of Regulation 2017/745, entitled ‘Classification of devices’, states:
‘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. …
…’
Directive 2006/42/EC
9.        Directive 2006/42/EC on machinery (‘the Machinery Directive’) (3) aims to harmonise the conditions in which machinery bearing the CE marking and accompanied by the EC 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.
10.      Article 3 of that directive, entitled ‘Specific Directives’, provides that
‘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’.
German law
11.      Paragraph 3 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 (‘the UWG’), entitled ‘Prohibition of unfair commercial practices’, provides, in subparagraph
1:
‘Unfair commercial practices shall be prohibited.’
12.      Paragraph 3a of the UWG, entitled ‘Infringement of the law’, is worded as follows:
‘Anyone who infringes a statutory provision intended, inter alia, to regulate market conduct in the interest of market players acts unfairly where that infringement is capable of having an appreciable adverse effect on the interests of consumers, other market players or competitors.’
13.      Paragraph 8 of the UWG, entitled ‘Cessation of conduct or injunctive relief’, states:
‘(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, the questions referred for a preliminary ruling and the procedure before the Court
14.      Dürr Dental manufactures compressors for the production of compressed air for dental treatment which, according to a decision of 23 January 2014 of the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) (Federal Institute for Drugs and Medical Devices, Germany), are risk class IIa medical devices within the meaning of Annex IX to Directive 93/42/EEC. (4)
15.      As a legally independent German representative of the company Cattani S.p.A., established in Italy, Cattani distributes, in Germany, what are known as ‘non-lubricated’ dry air compressors for the production of compressed air (‘the contested compressors’).
16.      In November 2020, Dürr Dental ordered from Cattani, as a test purchase, a compressor manufactured by the company Cattani S.p.A. The compressor delivered by Catani was CE marked as machinery. The manufacturer’s declaration of conformity which accompanied it referred not to Regulation 2017/745 on medical devices, but to Directive 2006/42 on machinery. In addition, that compressor did not have a four-digit identification number of the notified body responsible for the conformity assessment procedure, which must follow the CE marking of a risk class IIa medical device within the meaning of Regulation 2017/745. The appliance was accompanied by an instruction manual for the manufacturer’s ‘non-lubricated dry air compressors 1-2-3 cylinders’. Further information on the field of application of the compressors was available on the manufacturer’s website.
17.      According to Dürr Dental, it was apparent from the information in the instruction manual and on the manufacturer’s website that the contested compressors marketed by Cattani were accessories for risk class IIa medical devices within the meaning of Regulation 2017/745. The contested 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. According to
Dürr Dental, it falls to Cattani, as distributor, to verify and ensure compliance with that regulation, and so Dürr Dental sent Cattani a letter of formal notice in that regard.
18.      In early 2021, Dürr Dental made another test purchase from Cattani consisting of a compressor manufactured by Cattani S.p.A. That compressor had the same CE marking as the appliance delivered on the basis of the first order and was likewise accompanied by an instruction manual.
19.      According to Cattani, the obligations of distributors arising from Regulation 2017/745 cover only devices designated by the manufacturer as medical devices. In the present case, the manufacturer designated the contested compressors as technical appliances and not as medical devices. Cattani adds that, having been informed by Dürr Dental of the supposedly incorrect CE marking and received a letter of formal notice from Dürr Dental in that regard, it contacted the manufacturer in Italy, which confirmed that the device was not a medical device. Cattani also contacted the supervisory authority, which concluded that official measures were not necessary and that the device could remain on the market as it was.
20.      It is in that context that Dürr Dental applied to the Landgericht Stade (Regional Court, Stade, Germany) for an order prohibiting Cattani from making the contested compressors available on the market if they did not bear, as medical devices, a CE marking and a four-digit identification number assigned by a notified body. In the alternative, Dürr Dental requested that Cattani be prohibited from making available on the market those compressors not CE marked as medical devices. In addition Dürr Dental sought a declaration that Cattani is obliged to pay damages, provide information and reimburse the costs incurred in issuing the letter of formal notice, plus interest, as well as the costs of the first test purchase, plus interest.
21.      On 20 October 2021, the Landgericht Stade (Regional Court, Stade) upheld the claim for reimbursement of the costs of the first test purchase and dismissed the action as to the remainder.
22.      Further to the appeal lodged by Dürr Dental, the Oberlandesgericht Celle (Higher Regional Court, Celle, Germany) reversed in part the judgment of the Landgericht Stade (Regional Court, Stade) and made an order to cease and desist in line with its alternative claim. In addition, the appeal court took the view that Cattani was obliged to pay damages and ordered it to provide information and to pay the costs incurred in issuing the letter of formal notice, plus interest.
23.      In the appeal on a point of law lodged before the Bundesgerichtshof (Federal Court of Justice), Dürr Dental pursues its main claim for injunctive relief and its application for a related declaration. By its cross-appeal on a point of law, Cattani is seeking, first, to have the judgment given by the appeal court set aside in so far as it goes beyond the order made at first instance to reimburse the costs of the first test purchase, plus interest, and, secondly, to have the claims made by Dürr Dental on appeal dismissed.
24.      Since it has doubts concerning the scope of the obligations of distributors and the interpretation in that regard of Article 14(1) and of point (a) of the first subparagraph and the third subparagraph of Article 14(2) of Regulation 2017/745, 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?’
25.      The applicant and the defendant in the main proceedings, the Finnish and Greek Governments and the European Commission submitted observations in the present case.
Analysis
26.      As requested by the Court, this Opinion will focus solely on the first, second and third questions referred for a preliminary ruling.
27.      Before examining those questions, I consider it appropriate to make three preliminary observations regarding the applicable legal context.
Preliminary observations
28.      First, it should be observed that, prior to the adoption of Regulation 2017/745, Directive 93/42, adopted inter alia on the basis of Article 100 A of the EEC Treaty (now Article 114 TFEU), which relates to the approximation of laws with a view to the completion of the internal market, simply harmonised the conditions governing how medical devices are made available on the market and put into service with a view to their free movement within that market.
29.      In adopting Regulation 2017/745 on the basis of Article 114 and Article 168(4)(c) TFEU, which relate to the approximation of laws and the protection of public health by means of measures setting high standards of quality and safety for medical devices, the EU legislature sought, in particular, to align the legislation governing medical devices with the New Legislative Framework for the Marketing of Products, which is formed inter alia by Decision No 768/2008/EC. (5) In so doing, the legislature intended, inter alia, to clarify the general obligations on the various economic operators. After all, under 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, …, to enhance understanding of the requirements laid down in this Regulation and thus to improve regulatory compliance by the relevant operators’. (6)
30.      Secondly, I consider it relevant to recall that Regulation 2017/745 determines the obligations on the different economic operators, and in particular on manufacturers and distributors.
31.      A manufacturer is a ‘natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark’. (7) Its obligations are set out in Article 10 of Regulation 2017/745, paragraph 1 of which provides that, ‘when placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation’. It follows, in particular from paragraphs 2 to 6 of Article 10, that the manufacturer is required, inter alia, to draw up and keep up to date technical documentation for each device that it manufactures and to ensure that that documentation allows the conformity of the device with the requirements of that regulation to be assessed. Where compliance with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, the manufacturer is to draw up an EU declaration of conformity and affix the CE marking of conformity.
32.      In accordance with Article 19 of Regulation 2017/475, the EU declaration of conformity is to state that the requirements specified in that regulation have been fulfilled in relation to the device that is covered. The EC marking of conformity, provided for in Article 20 of that regulation, is to be affixed, before the device is placed on the market, on the device or on its packaging. It is also to appear in the instructions for use and on any sales packaging. It is the device’s ‘technical passport’ and opens up the doors to the other Member States to the device. (8)
33.      For its part, a distributor is defined as ‘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’. (9) Pursuant to Article 14 of Regulation 2017/745, when making a device available on the market, a distributor is, in the context of its activities, to act with due care in relation to the requirements applicable. It must inter alia verify, beforehand, that certain requirements laid down in that regulation on the manufacturer and on the importer have indeed been met, and in particular that the device is CE marked, that the EU declaration of conformity has been drawn up and that the device is accompanied by the information to be supplied by the manufacturer.
34.      Furthermore, devices are to be divided into classes
I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. (10) The conformity assessment procedure for class
I devices should be carried out, as a general rule, under the sole responsibility of manufacturers in view of the low level of vulnerability associated with such devices. For class
IIa, class
IIb and class
III medical devices, an appropriate level of involvement of a notified body should be compulsory. (11)
35.      Thirdly, I note that the Machinery Directive, upon which the manufacturer of the contested compressors relied to affix the CE marking and draw up the EU declaration of conformity, provides, in Article 3 thereof, that, where machinery gives rise to hazards referred to in Annex I to that directive and where those hazards are wholly or partly covered more specifically by other EU legislation, that
directive is not to apply, or is to cease to apply, to that machinery in respect of such hazards from the date of implementation of that other legislation. The Machinery Directive thus appears to be the lex generalis, which applies only where there is no lex specialis; the lex specialis in the present case is Regulation 2017/745. The Guide to application of the Machinery Directive (12) confirms that interpretation. It essentially states, in paragraph 90 thereof, that the legislation on medical devices deals more specifically than the Machinery Directive with the hazards of machinery intended for medical use. That directive is therefore not applicable to machinery falling within the scope of the legislation on medical devices.
36.      The Machinery Directive defines a manufacturer as ‘any natural or legal person who designs and/or manufactures machinery or partly completed machinery covered by this Directive and is responsible for the conformity of the machinery or the partly completed machinery with this Directive with a view to its being placed on the market, under his own name or trademark or for his own use. In the absence of a manufacturer as defined above, any natural or legal person who places on the market or puts into service machinery or partly completed machinery covered by this Directive shall be considered a manufacturer’. (13)
37.      Article 5 of that directive provides in addition that, before placing machinery on the market and/or putting it into service, the manufacturer has a number of obligations, including the obligations to provide the necessary information, draw up the EC declaration of conformity and affix the CE marking. Different procedures for assessing the conformity of machinery are laid down in Article 12 of that directive. Those procedures vary according to the category of machinery, with the involvement of a notified body sometimes being mandatory.
38.      The concept of ‘distributor’ does not exist as such in the Machinery Directive. It does appear in Regulation 2023/1230, applicable with effect from 14 January 2027. (14) That new regulation on machinery contains certain provisions which are aligned with Decision No 768/2008, including those concerning general obligations of economic operators. (15)
39.      It is in that context that the first three questions referred for a preliminary ruling in the present case should be examined, the first two of which can be analysed jointly given the connection between them.
The first and second questions
40.      By its first two questions, the referring court is, in essence, asking the Court whether Article 14(1) and point (a) of the first subparagraph of Article 14(2) of Regulation 2017/745 must be interpreted as meaning that it requires the distributor to verify whether a device which it makes available on the market is to be regarded as a medical device and whether it is relevant for the answer to that question that that device has been CE marked by the manufacturer as a medical device, as an accessory for a medical device or as machinery within the meaning of the Machinery Directive.
41.      In other words, it asks about the scope of the distributor’s obligations as regards verification of the classification as a medical device, in a situation in which the manufacturer has CE marked the device as machinery.
42.      I must make two preliminary observations.
43.      First, it is apparent from the request for a preliminary ruling that there can be no doubt that, in the present case, the contested compressors are accessories for a medical device and, as such, come under Regulation 2017/745. 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 to support the medical function of that device. (16) Accordingly, pursuant to Article 3 of the Machinery Directive, that directive was not applicable in principle, contrary to the assessment made by the manufacturer in the present case.
44.      Secondly, it is apparent from the request for a preliminary ruling that, in the present case, Cattani acted as the representative in Germany of the Italian manufacturer and therefore as a ‘distributor’ within the meaning of point 34 of Article 2 of Regulation 2017/745. Article 16 of that regulation, which concerns the cases in which obligations of manufacturers apply inter alia to distributors, for example where the distributor markets the device under its name or its trademark or where it changes the device’s intended purpose, does not apply here. (17)
45.      Having made those two observations, I recall that it is settled case-law that, for the purpose of interpreting a provision of EU law, it is necessary to consider not only its wording but also its context and the objectives of the legislation of which it forms part. (18)
46.      With a view to analysing the scope of the obligations on distributors, as set out in Article 14(1) and point (a) of the first subparagraph of Article 14(2) of Regulation 2017/745, the interpretation of which is requested, I will examine the obligations of distributors arising from the wording of the provisions, before carrying out a more contextual and teleological analysis of them.
Literal interpretation
47.      Pursuant to Article 14(1) of Regulation 2017/745, distributors are to act with ‘due care in relation to the requirements applicable’. The first subparagraph of Article 14(2) of that regulation specifies that, before making a device available on the market, distributors are to verify inter alia that that device has been CE marked and that the EU declaration of conformity of the device has been drawn up (point (a)); that the device is accompanied by the necessary information (point (b)); that the importer has complied with the requirements applicable to it (point (c)); and that, where applicable, the manufacturer has assigned a UDI (point (d)). (19)
48.      Therefore, it is apparent from the wording of the first subparagraph of Article 14(2) of Regulation 2017/745, which lists very specific obligations on distributors, that, pursuant to point (a), distributors are to verify the existence of the CE marking and the EU declaration of conformity for the device in question and not their accuracy.
49.      In other words, it follows from the wording of the provisions at issue that the assessment of a product’s classification as a medical device, as an accessory for a medical device or as something else is not the responsibility of the distributor, and that the checks which it has to carry out appear to be purely formal in nature.
50.      However, such a – restrictive – approach to the obligations of a distributor of medical devices could be qualified in the light of the context of those obligations.
Contextual interpretation
51.      A device’s compliance with the applicable legislation is primarily a matter for the manufacturer and not the distributor. This appears consistent with the fact that it is the manufacturer which knows its product best and is the best placed to determine which legislation applies. Furthermore, it follows from point 43 of Article 2 of Regulation 2017/745 that it is the manufacturer which is responsible for correctly affixing the CE marking. It is likewise the manufacturer which, when drawing up the EU declaration of conformity, assumes ‘responsibility for compliance with the requirements of this Regulation and all other Union legislation applicable to the device’. (20) Moreover, Article 16 of Regulation 2017/745 assigns the manufacturer’s obligations to the distributor only in very specific situations which it lists exhaustively, none of which applies here. (21)
52.      However, I note 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 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’.
53.      It follows from that provision that, before making the device available on the market, the distributor must notify the relevant operators if it is aware of a problem in connection with the conformity of the device with Regulation 2017/745.
54.      Yet, a misclassification of the product at issue by the manufacturer may mean that that product is not in conformity with the applicable legislation. For instance, if, as in the dispute in the main proceedings, a product is classified as ‘machinery’ rather than as an ‘accessory for a medical device’, the legislation on machinery, which is applied by the manufacturer, is not relevant, in accordance with Article 3 of the Machinery Directive. 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 certificate of conformity are for machinery rather than for a medical device.
55.      It is therefore my view that it can be inferred from the third subparagraph of Article 14(2) of Regulation 2017/745 that, before making a device available on the market, the distributor may be called upon to take action, even though it does not bear responsibility for such conformity. (22)
56.      In addition, in order to clarify the scope of the obligations of distributors, it is relevant to refer to the Commission notice, that is, the ‘Blue Guide’ on the implementation of EU product rules 2022 (‘the Blue Guide’). (23) The Blue Guide is a guidance document that is intended to contribute inter alia to ensuring that the New Legislative Framework for the Marketing of Products is applied uniformly and coherently. Although not legally binding, it provides useful information for the interpretation of the relevant provisions of EU law. (24)
57.      With a view specifically to defining the scope of the ‘due care’ required of a distributor, it is interesting to note that section
3.4 of the Blue Guide, entitled ‘Distributor’, defines ‘due care’ as ‘the effort made by an ordinarily prudent or reasonable party to avoid harm to another, taking the circumstances into account’. It is explained that ‘[this] refers to the level of judgment, care, prudence, determination, and activity that a person would reasonably be expected to do under particular circumstances’. (25)
58.      According to that guide, ‘distributors must act with due care in relation to the applicable requirements. They have to know, for instance, which products must bear the CE marking, what information is to accompany the product (for example the EU Declaration of Conformity), what are the language requirements for labelling, user instructions or other accompanying documents, and what is a clear indication of the product being non-compliant. Distributors have an obligation to demonstrate to the national market surveillance authority that they have acted with due care and ensure that the manufacturer, or his authorised representative, or the person who provided him with the product has taken the measures required by the applicable Union harmonisation legislation as listed in the obligations for distributors’. Similarly, ‘distributors must not supply products that they know or should have assumed, on the basis of information in their possession and as a professional, not to be in compliance with the legislation’. The Blue Guide adds in Annex 5 that the distributor ‘should be able to identify products that are clearly not in compliance’. (26)
59.      While, in the light of the first subparagraph of Article 14(2) of Regulation 2017/745, it appears to me contra legem to require distributors to verify the classification of every product and, in so doing, to repeat systematically the conformity assessment carried out by the manufacturer, it seems to me that their obligation to act with ‘due care’, within the meaning of Article 14(1), in conjunction with the third subparagraph of Article 14(2), does nevertheless require them to show a degree of vigilance before making a device available on the market. (27)
60.      I do consider, however, that distributors may be required to carry out only a verification ‘of consistency’, based on the documents at their disposal or which are available to them.
61.      In that regard, the declaration of conformity, the marking of the product and the instructions for use are documents at the distributor’s disposal which may enable it to make the relevant checks. For example, in the situation mentioned by the referring court in its second question referred for a preliminary ruling, in which a device has been CE marked by the manufacturer and that marking corresponds to different legislation (in the present case the Machinery Directive), the declaration of conformity may enable a clear inconsistency to be identified in that regard, in particular if the intended use of the product is quite clearly medical and there can be no doubt that it is an accessory for a medical device. Similarly, as the referring court notes in the present case, useful information about the field of application of the products at issue may appear on the manufacturer’s website. In addition, as the Finnish Government observes, the commercial promotional material may also contain relevant information.
62.      That information, which is easily accessible, may thus make it possible to assess whether or not the distributor has shown due diligence.
63.      By contrast, documentation of a significantly technical nature should not necessarily have to be taken into account in connection with the distributor’s obligation to act with
due care. Similarly, such an obligation should be imposed only where the classification error is clear. (28)
Teleological interpretation
64.      The objectives set by Regulation 2017/745 appear to me to confirm such an interpretation.
65.      After all, I would recall that the origin of that regulation, which was adopted following the PIP scandal, (29) specifically demonstrates the will of the EU legislature to clarify the obligations of manufacturers, importers and distributors, as noted in point 29 of this Opinion.
66.      Regulation 2017/745 was adopted as part of an approach intended to ‘adapt the medical device legislation to the needs of tomorrow so as to achieve a suitable, robust, transparent and sustainable regulatory framework’, capable of fostering the ‘development of safe, effective and innovative medical devices’. (30) It is thus 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 small- and medium-sized enterprises 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’.
67.      In addition, I am of the view that the interpretation that consists in imposing on distributors an obligation to verify consistency, as described in points 60 to 63 of this Opinion, is capable of achieving all the objectives of Regulation 2017/745 recalled therein.
68.      First, by requiring them to take action if the classification made by the manufacturer is clearly incorrect, it appears to me that distributors, that is, the small- and medium-sized enterprises active in that sector, are not disadvantaged through the placement of an unreasonable burden on them, in the light of the health and safety objectives laid down. Such an interpretation also appears to me to be consistent with the obligation on all economic operators ‘to act responsibly’ within the meaning of recital 18 of Decision No 768/2008. (31)
69.      Secondly, I consider that the objective that consists in ensuring a high level of safety and of protection of the health of patients and users would not be achieved if a medical device which is clearly not in conformity with the applicable legislation were nevertheless, and automatically, made available on the market by the distributor, without the latter having made the appropriate checks and taken the appropriate steps, in accordance with its obligation to act with due care. (32)
70.      Lastly, I would add that, contrary to what Cattani contends, such an approach does not appear to me to place the responsibility for the conformity of products on the shoulders of distributors. As the referring court observed, the distributor’s obligations stem from the obligation to act with due care within the meaning of Article 14(1) and (2) of Regulation 2017/745. 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.
71.      I therefore consider that the referring court must assess, taking into account the circumstances, the efforts which the distributor has to make as part of its obligation to act with due care within the meaning of Article 14(1) of Regulation 2017/745. The basic knowledge expected of a distributor of medical devices, the content of the documents accessible to it and the technical difficulty of the case in question are factors relevant to assessing the level of effort expected of an ‘ordinarily prudent or reasonable’ distributor.
Conclusion on the first and second questions
72.      In the light of all the foregoing considerations, I propose that the Court answer the first and second questions to the effect 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 which it makes available on the market clearly concern a device falling within the scope of that regulation.
The third question
73.      By its third question, the referring court asks whether point (a) of the first subparagraph of Article 14(2), read in conjunction with Article 14(1), of Regulation 2017/745 is to be interpreted as meaning that verification obligations of a distributor include verifying whether the device which it makes available on the market must be classified in risk class
IIa within the meaning of that regulation and, therefore, whether it must bear a four-digit identification number of a notified body.
74.      It should be recalled that, in essence, the manufacturer has to determine the class of its medical device in order to determine the applicable requirements. Under Article 51(1) of Regulation 2017/745, ‘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’. Identifying the class of the device enables the manufacturer to identify 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 conformity with that regulation. (33)
75.      While some class
I devices may be self-certified by the manufacturer, 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 medical devices available. (34) Where the notified body is involved in the certification of the risk class of a device, the CE marking must be accompanied by that body’s identification number. (35)
76.      Further to my answer to the first two questions referred for a preliminary ruling, I consider that verification of the accuracy of the classification into a risk class and, therefore, of the need for a four-digit identification number of a notified body goes beyond the obligation to verify consistency borne by distributors under their duty of care.
77.      First, the classification of the medical device is a matter for the manufacturer, which ‘is obliged to initiate a conformity assessment procedure for its product, the success of which will determine its arrival on the market’. (36) As the Commission notes in its written observations, precise knowledge of the design, operation and/or intended purpose of the device is needed to determine that classification.
78.      Secondly, the fact that, depending on the risk class, a notified body must be involved in the conformity assessment procedure confirms the complexity of that classification process. The notified bodies are, moreover, bound by certain requirements. (37) For example, they must have permanent availability of sufficient administrative, technical and scientific personnel and have 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 they have 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 Regulation 2017/745 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.
79.      Those factors confirm the complexity of the classification process.
80.      Accordingly, 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 and, therefore, expand, as a corollary, the potential scope of its liability. (38)
81.      Thirdly, requiring the distributor to verify the accuracy of the classification also appears to me to run counter to the objectives set by Regulation 2017/745.
82.      On the one hand, such an interpretation could blur the lines between the obligations of the various economic operators, in breach of the objective of clarity, and therefore of legal certainty, set out in recital 27 of Regulation 2017/745. (39)
83.      On the other hand, the distributor is not necessarily equipped to verify the accuracy of the classification, particularly if it is a small- or medium-sized enterprise. Furthermore, it is apparent from the Blue Guide that the distributor must have ‘a basic knowledge’ of the legal requirements. (40) Such verification could therefore prove overly burdensome and, therefore, contrary to the objective of safety and of protection of health for patients and users if the distributor, unlike the notified bodies, (41) does not have the necessary personnel, equipment and competences in that regard.
84.      It can, admittedly, be concluded, as the Commission does, that, in the specific situation in which the device was classified by the manufacturer such that a notified body was necessarily involved (classes
IIa, IIb or III), the distributor’s obligation to act with due care may require it to verify, in accordance with Article 20(5) of Regulation 2017/745, that the CE marking is followed by the identification number of that notified body. Such a formal verification can be included in the verification of the CE marking, as provided for in point (a) of the first subparagraph of Article 14(2) of Regulation 2017/745.
85.      That said, aside from that situation, I am of the view that 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.
86.      Finally, such an interpretation does not appear to me to be called into question by Dürr Dental’s argument that, in essence, this would make it impossible to bring any action against non-compliant devices being made available on the market. Dürr Dental cites the example of a manufacturer which classifies its device in class
I, thus sparing itself the involvement of a notified body. However, I take the view that the manufacturer’s responsibility for the incorrect classification cannot for that reason be imputed to the distributor. It should be possible to hold the manufacturer of the ‘incorrectly classified’ device liable for that misclassification, in accordance with the legal remedies provided for in national law and in accordance with the principles of equivalence and effectiveness. Moreover, ‘post-market surveillance’ and ‘market surveillance’ are provided for in Regulation 2017/745 (42) and do not fall in the first instance to the distributor, even though, as an economic operator, it may be called upon to cooperate or to issue an alert in the case of a clearly incorrect classification.
87.      In the light of all the foregoing considerations, I propose that the Court answer the third question referred for a preliminary ruling to the effect that 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 the obligations of the distributor do not require it to verify whether the device must be classified in risk class
IIa within the meaning of that regulation. However, if it is apparent from the information provided to the distributor that the device is classified by the manufacturer in a risk class necessarily entailing the involvement of a notified body, the distributor’s obligations to act with due care may require it to verify that the identification number of that body is indicated.
Conclusion
88.      In the light of the foregoing considerations, I propose that the Court of Justice answer the first, second and third questions referred for a preliminary ruling by the Bundesgerichtshof (Federal Court of Justice, Germany) as follows:
(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 which 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 the obligations of the distributor do not require it to verify whether the device must be classified in risk class
IIa within the meaning of that regulation. However, if it is apparent from the information provided to the distributor that the device is classified by the manufacturer in a risk class necessarily entailing the involvement of a notified body, the distributor’s obligations to act with due care may require it to verify that the identification number of that body is indicated.
1      Original language: French.
2      Regulation 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).
3      Directive 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). 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 of the European Parliament and of the Council and Council Directive 73/361/EEC (OJ 2023 L 165, p. 1). However, pursuant to Article 51(2) of Regulation 2023/1230, the Machinery Directive remains applicable until January 2027.
4      Council Directive of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1), which was repealed by Regulation 2017/745.
5      Decision 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 forms part of the New Legislative Framework for the Marketing of Products and sets out the common framework of general principles and reference provisions for the drawing up of Community legislation harmonising the conditions for the marketing of products in the European Union. Chapter
R2 of Annex I to that decision contains the provisions on the obligations of economic operators.
6      See also paragraph 3.2, entitled ‘Making available of devices, obligations of economic operators, reprocessing, CE marking, free movement (Chapter
II)’ of the Proposal for Regulation 2017/745 (COM(2012)
542 final – 2012/0266 (COD)) of 26 September 2012. Moreover, see Garnier, E. and Perroy, A.-C., ‘Le Règlement européen no 2017/745 sur les dispositifs médicaux: une clarification des responsabilités des opérateurs économiques’, Revue de droit sanitaire et social, 2018, p. 19.
7      Point 30 of Article 2 of Regulation 2017/745.
8      See Daburon, C., ‘Les objectifs de la réglementation européenne en matière de dispositifs médicaux’, Revue juridique de l’Ouest, Vol. 2, 2000, p. 130.
9      Point 34 of Article 2 of Regulation 2017/745. The activities of distributors include the acquisition, holding and supplying of devices (recital 28
of Regulation 2017/745). The only activity at issue here is the supplying (making available on the market) of devices.
10      See Article 51(1) of Regulation 2017/745.
11      See recital 60
of Regulation 2017/745. Point 42 of Article 2 of that regulation defines the notified body as ‘a conformity assessment body designated in accordance with [Regulation 2017/745]’.
12      European Commission, ‘Guide to application of the Machinery Directive 2006/42/EC’, ed.
2.3, April 2024.
13      See Article 2(i) of the Machinery Directive.
14      See Article 54
of Regulation 2023/1230.
15      See recital 9
of Regulation 2023/1230.
16      The referring court adds, furthermore, that the
Federal Institute for Drugs and Medical Devices decided in 2014 that the compressors manufactured by Dürr Dental were risk class
IIa medical devices.
17      Under Article 16(1) of Regulation 2017/745, a distributor ‘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’.
18      See, for example, judgment of
13 March 2025, Cassella-med and MCM Klosterfrau (C‑589/23, EU:C:2025:173, paragraph 38).
19      Article 27
of Regulation 2017/745 provides that the Unique Device Identification system (‘UDI system’) described in Part
C of Annex VI is to allow the identification and facilitate the traceability of devices, other than custom-made and investigational devices.
20      See Article 19(3) of Regulation 2017/745.
21      See point 44 of this Opinion.
22      As Cattani essentially states by analogy
with the judgment of
8 September 2005, Yonemoto (C‑40/04, EU:C:2005:519, paragraphs 44
and 53), it would be inconsistent with the scheme of Regulation 2017/745 to make the distributor responsible for the conformity of medical devices with the requirements laid down in that regulation.
23      OJ 2022 C 247, p. 1.
24      See, to that effect, judgments of
6 September
2012, Chemische Fabrik Kreussler (C‑308/11, EU:C:2012:548, paragraph 25), and of
13 March 2025, Cassella-med and MCM Klosterfrau (C‑589/23, EU:C:2025:173, paragraph 40).
25      See Blue Guide, p. 41, esp. footnote 146.
26      See Blue Guide, Annex 5, entitled ‘Frequently Asked Questions on CE marking’, p. 151. Emphasis added.
27      I would make a distinction here between the due care to be demonstrated by distributors in their relationship with the manufacturer before a product is placed on the market and their key role in terms of market surveillance after its placement on the market.
28      The classification of a product as a medical device is not always obvious. See, in relation to the classification of software as a medical device, judgment of 7 December 2017, Snitem and Philips France (C‑329/16, EU:C:2017:947); see, in relation to the distinction between a medical device and a medicinal product, judgments of 3 October 2013, Laboratoires Lyocentre (C‑109/12, EU:C:2013:626, paragraph 44); of
25 October 2018, Boston Scientific (C‑527/17, EU:C:2018:867, paragraph 34); and of 19 January 2023, Bundesrepublik Deutschland (Nasal drops) (C‑495/21 and
C‑496/21, EU:C:2023:34, paragraph 49). See also the Medical Device Coordination Group guidance document, entitled ‘MDCG 2022 – 5 Rev.
1 – Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices’, October 2024. In addition, see Peigné, J., ‘La notion de dispositif médical issue du règlement (UE) 2017/745 du 5 avril 2017’, Revue de droit sanitaire et social, Dalloz, Vol. 1, 2018, p. 5 (esp. paragraph II.B), which makes clear that the relationship between the application of Regulation 2017/745 and other categories of regulated products, and therefore with other instruments, is not always obvious, ‘particularly where [those] products are associated and combined with or incorporated within each other’.
29      See Council conclusions of 6 June 2011 on innovation in the medical device sector (OJ 2011 C 202, p. 7) and the European Parliament Resolution of 14 June 2012 on defective silicone gel breast implants made by the French company PIP (2012/2621(RSP)). See, in response, the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, entitled ‘Safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals’ (COM(2012) 540 final of
26 September 2012); the Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 (COM(2012) 542 final of
26 September 2012); and the Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices (COM(2012) 541 final of
26 September 2012).
30      See footnote 29
to this Opinion.
31      That recital states that ‘all economic operators are expected to act responsibly and in full accordance with the legal requirements applicable when placing or making products available on the market’.
32      I note that the due care that may be exercised by the distributor (see, in that regard, that exercised by Cattani, to which reference is made in point 19 of this Opinion) 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 is a matter for the referring court to assess.
33      That conformity assessment procedure is explained in Article 52
of Regulation 2017/745.
34      See Article 53
of Regulation 2017/745, entitled ‘Involvement of notified bodies in conformity assessment procedures’.
35      Article 20(5) of Regulation 2017/745 provides that ‘where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 52. The identification number shall also be indicated in any promotional material which mentions that a device fulfils the requirements for CE marking’. See also section 4.5.1.5 of the Blue Guide.
36      See Le Gal Fontes, C. and Chanet, M., ‘Le rôle et les conditions de surveillance des organismes notifiés: une réforme tant attendue …’, Revue de droit sanitaire et social, Dalloz, Vol. 1, 2018, p. 34 et seq..
37      See, in that regard, 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’.
38      Although liability for defective products is not at issue here, it appears that, in Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ 1985 L 210, p. 29), as in Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products and repealing Council Directive 85/374/EEC (OJ L, 2024/2853), which repeals that earlier directive with effect from 9 December 2026, the liability of the provider/distributor remains subsidiary vis-à-vis that of the producer/manufacturer.
39      As recalled in point 29 of this Opinion, pursuant to recital 27, ‘it is appropriate to set out clearly the general obligations of the different economic operators’, which gives those operators a degree of legal certainty as to their obligations.
40      See Blue Guide, Annex 5, p. 151.
41      See, in that regard, the necessary requirements of notified bodies, as recalled in point 78 of this Opinion.
42      Point 60 of Article 2 of that regulation defines ‘post-market surveillance’ as 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. Point 61 of Article 2 of that regulation defines ‘market surveillance’ as 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 EU harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection.