1 This request for a preliminary ruling concerns the interpretation of Article 1(2)(f) and Article 11 of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1), as amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 (OJ 2007 L 247, p. 21), (‘Directive 93/42’).
2 The request has been made in proceedings between Lohmann & Rauscher International GmbH & Co. KG (‘L&R’) and BIOS Medical Services GmbH, formerly BIOS Naturprodukte GmbH, (‘Bios’) concerning the sale by the latter of surgical wound dressings manufactured by L&R.
3 The fifth and twelfth recitals of Directive 93/42 read as follows: ‘Whereas medical devices should provide patients, users and third parties with a high level of protection and attain the performance levels attributed to them by the manufacturer; whereas, therefore, the maintenance or improvement of the level of protection attained in the Member States is one of the essential objectives of this Directive; … Whereas, in order to demonstrate conformity with the essential requirements and to enable conformity to be verified, it is desirable to have harmonised European standards to protect against the risks associated with the design, manufacture and packaging of medical devices; whereas such harmonised European standards are drawn up by private-law bodies and should retain their status as non-mandatory texts; whereas, to this end, the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) are recognised as the competent bodies for the adoption of harmonised standards in accordance with the general guidelines on cooperation between the Commission and these two bodies signed on 13 November 1984; …’
4 Article 1(2)(f) of that directive defines the concept of ‘manufacturer’ as follows: ‘… the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party. The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as devices with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient’.
5 The first paragraph of Article 3 of that directive states: ‘The devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned.’
6 Article 4(1) of that directive provides: ‘Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices bearing the CE marking provided for in Article 17 which indicate that they have been the subject of an assessment of their conformity in accordance with the provisions of Article 11.’
7 Under Article 10 of Directive 93/42: ‘1. Member States shall take the necessary steps to ensure that any information brought to their knowledge, in accordance with the provisions of this Directive, regarding the incidents mentioned below involving a Class I, IIa, IIb or III device is recorded and evaluated centrally: (a) any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health; (b) any technical or medical reason in relation to the characteristics or performance of a device for the reasons referred to in subparagraph (a), leading to systematic recall of devices of the same type by the manufacturer. 2. Where a Member State requires medical practitioners or the medical institutions to inform the competent authorities of any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorised representative, is also informed of the incident. 3. After carrying out an assessment, if possible together with the manufacturer or his authorised representative, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimise the recurrence of the incidents referred to in paragraph 1, including information on the underlying incidents. …’
8 Article 11(5) of that directive provides: ‘In the case of devices falling within Class I, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex VII and draw up the EC declaration of conformity required before placing the device on the market.’
9 According to Article 14b of that directive: ‘Where a Member State considers, in relation to a given product or group of products, that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed, such products should be withdrawn from the market, or their placing on the market and putting into service should be prohibited, restricted or subjected to particular requirements, it may take any necessary and justified transitional measures. The Member State shall then inform the Commission and all other Member States, giving the reasons for its decision. The Commission shall, whenever possible, consult the interested Parties and the Member States. The Commission shall adopt its opinion, indicating whether the national measures are justified or not. The Commission shall inform all the Member States and the consulted interested Parties thereof. …’
10 Article 17(1) of that directive provides: ‘Devices, other than devices which are custom-made or intended for clinical investigations, considered to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market.’
11 Point 13 of Annex I to Directive 93/42 reads as follows: ‘13. Information supplied by the manufacturer 13.1. Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer. This information comprises the details on the label and the data in the instructions for use. As far as practicable and appropriate, the information needed to use the device safely must be set out on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging. If individual packaging of each unit is not practicable, the information must be set out in the leaflet supplied with one or more devices. … 13.3. The label must bear the following particulars: (a) the name or trade name and the address of the manufacturer. For devices imported into the [European Union], in view of their distribution in the [European Union], the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the [European Union]; (b) the details strictly necessary to identify the device and the contents of the packaging especially for the users; (c) where appropriate, the word “STERILE”; (d) where appropriate, the batch code, preceded by the word “LOT”, or the serial number; (e) where appropriate, an indication of the date by which the device should be used, in safety, expressed as the year and month; … 13.4. If the intended purpose of the device is not obvious to the user, the manufacturer must clearly state it on the label and in the instructions for use. 13.5. Wherever reasonable and practicable, the devices and detachable components must be identified, where appropriate in terms of batches, to allow all appropriate action to detect any potential risk posed by the devices and detachable components. …’
12 Annex IX to Directive 93/42, under Title III, point 1.4, is worded as follows: ‘All non-invasive devices which come into contact with injured skin: - are in Class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates, …’
13 Paragraph 6(1) of the Gesetz über Medizinprodukte (Law on medical devices, BGBl. 2002 I, p. 3146; ‘the MPG’) reads as follows: ‘Medical devices, with the exception of custom-made devices, own-manufactured medical devices, medical devices referred to in Paragraph 11(1), and medical devices intended for clinical checks, or in vitro diagnostic devices or devices for performance evaluations, may be placed on the market or put into service in Germany only if they bear the CE marking provided for in the first sentence of subparagraph 2 and in the first sentence of subparagraph 3. …’
14 Paragraph 6(2) of the MPG provides: ‘Medical devices may bear the CE marking only if the fundamental requirements of Paragraph 7 of the MPG, which apply to them having regard to their purpose, are satisfied and a conformity assessment procedure specified for the medical device in question has been carried out in accordance with the conditions laid down by the Regulation [on medical devices] referred to in Paragraph 37(1) [of the MPG].’
15 Paragraph 7(1) of the MPG states: ‘The essential requirements for active implantable medical devices are those set out in Annex 1 to Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ 1990 L 189, p. 17), as last amended by Article 1 of Directive [2007/47]; for in vitro diagnostic medical devices, the requirements of Annex I to Directive [98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ 1998 L 331, p. 1)]; and for other medical devices, the requirements of Annex I to Directive [93/42], as they respectively apply.’
16 Paragraph 7(4) of the Verordnung über Medizinprodukte (Regulation on medical devices, BGBl. 2001 I, p. 3854) provides: ‘For Class I medical devices, with the exception of the devices referred to in subparagraphs 5 and 9, the manufacturer must carry out the procedure referred to in Annex VII to Directive [93/42].’
17 L&R manufactures sterile surgical wound dressings. The packaging indicates that L&R is the manufacturer of those products. L&R has issued a declaration of conformity for those Class I medical devices, which bear a CE marking.
18 Bios acquires in other Member States the products manufactured by L&R with a view to importing them into Germany and reselling them. To this end, Bios affixes to the original packaging a label identifying it as responsible for placing those products on the market in Germany and indicating its postal and electronic addresses as well as its telephone and fax numbers. The label also includes, in the form of a bar code, Bios’ ‘central pharmaceutical number’. The referring court states that that number, which is not laid down by any legislative or regulatory measure in Germany, is intended to facilitate the accounting transactions of pharmacies, health insurance funds and wholesalers. All other indications on the original packaging of the product remain visible, with the exception of the central pharmaceutical number of L&R and its affiliated distribution company.
19 L&R is of the view that Bios acted unlawfully by altering the packaging of a product bearing a CE marking without carrying out a supplementary conformity assessment. It brought an action seeking an order requiring Bios to cease its activities; that action was dismissed at first instance.
20 Hearing an appeal brought against that decision, the referring court takes the view that the outcome of the dispute depends on the interpretation of Directive 93/42. It is clear from the explanations provided by that court that L&R claims that Bios has infringed Paragraph 6 of the MPG, which transposes Article 17 of Directive 93/42.
21 The referring court is faced with the question of whether the mere fact of affixing the label described above imposes an obligation on the parallel importer to carry out a conformity assessment within the meaning of Article 11 of Directive 93/42.
22 In the context of the proceedings before the referring court, L&R relied on the concept of ‘manufacturer’, defined in Article 1(2)(f) of Directive 93/42, in order to maintain that Bios must be considered to be a manufacturer when it affixes a label with a new central pharmaceutical number.
23 The referring court, however, takes the view that such an approach risks undermining the principle of freedom of movement laid down in Article 4 of Directive 93/42 in cases where the alteration to the labelling is not linked to the safety and performance aspects of the device in question. That court doubts whether the label affixed by Bios poses a safety problem in so far as the information required by point 13 of Annex I to Directive 93/42, in particular the identity of the manufacturer and the lot number, remains legible, without it being possible for the public to be induced into believing that Bios is the manufacturer of the product at issue.
24 In those circumstances, the Oberlandesgericht Düsseldorf (Higher Regional Court, Düsseldorf) decided to stay the proceedings and to refer the following question to the Court of Justice for a preliminary ruling: ‘Are Article 1(2)(f), Article 11, point 13 of Annex I and the last indent of point 3 of Annex VII [to Directive 93/42] to be interpreted as meaning that a further conformity assessment procedure is required for the marketing of a Class I medical device, which has been subjected to a conformity assessment procedure by the manufacturer and lawfully bears the CE marking affixed by the manufacturer, where the information relating to the central pharmaceutical number on the outer packaging of the medical device has been concealed by a sticker which provides the importer’s details and the central pharmaceutical number granted to that importer, the other information remaining visible?’
25 The referring court asks, in essence, whether Article 1(2)(f) and Article 11 of Directive 93/42 must be interpreted as requiring a parallel importer of a medical device, such as that at issue in the main proceedings, which bears a CE marking and which has been subjected to a conformity assessment within the meaning of that Article 11, to carry out a further assessment designed to certify the conformity of the information allowing its identification which that parallel importer adds to the labelling of that device with a view to that device being placed on the market of the Member State of importation.
26 In order to answer the question referred, it is useful to recall the obligations imposed by Directive 93/42 on manufacturers and other persons referred to in Article 1(2)(f) of that directive for the purposes of the conformity assessment provided for in Article 11 of that directive for a medical device such as that at issue in the main proceedings.
27 In this regard, it should be noted that Directive 93/42, which constitutes a harmonisation measure adopted pursuant to Article 100a of the EC Treaty (subsequently Article 95 EC), is intended to promote the free movement of medical devices which comply with the requirements of that directive, by replacing the various legislative, regulatory and administrative measures in force in the Member States which create barriers to free trade (judgments of 14 June 2007, Medipac-Kazantzidis, C‑6/05, EU:C:2007:337, paragraph 51, and of 19 November 2009, Nordiska Dental, C‑288/08, EU:C:2009:718, paragraph 20).
28 Directive 93/42 harmonises the essential requirements to be met by medical devices falling within its scope of application. Once those devices comply with the harmonised standards and are certified in accordance with the procedures provided for by that directive, they must be presumed to comply with those essential requirements and therefore be deemed to be appropriate for the use for which they are intended (judgment of 14 June 2007, Medipac-Kazantzidis, C‑6/05, EU:C:2007:337, paragraph 42).
29 To that end, Article 17(1) of Directive 93/42 provides that all medical devices, other than devices which are custom-made or intended for clinical investigations, which are considered to meet the essential requirements referred to in Article 3 thereof must bear the CE marking of conformity when they are placed on the market. Article 4(1) of that directive prohibits Member States from creating any obstacle to the placing on the market of devices bearing the CE marking which indicate that they have been the subject of an assessment of their conformity in accordance with the provisions of Article 11 of that directive.
30 It therefore follows from those provisions that medical devices the conformity of which with the essential requirements of Directive 93/42 has been evaluated according to one of the procedures laid down in Article 11 of that directive and which bear a CE marking must be allowed to move freely throughout the European Union, and no Member State can require that such a product must undergo a further conformity assessment procedure (see, to that effect, judgment of 14 June 2007, Medipac-Kazantzidis, C‑6/05, EU:C:2007:337, paragraph 42). That is the reason why Directive 93/42 does not provide for any compliance review mechanism to be added to or supplement those provided for in Article 11 of that directive.
31 Nevertheless, the referring court is unsure whether, as L&R claims, for reasons of patient safety, a parallel importer which alters the labelling of a medical device by adding information which enables it to be identified should not be treated in the same way as a manufacturer and, consequently, be required to carry out a supplementary conformity assessment.
32 It should, in this regard, be pointed out that the obligation to carry out the conformity assessment laid down in Article 11 of Directive 93/42 is addressed solely to manufacturers. Article 1(2)(f) of that directive refers, in each of its two subparagraphs, to categories of persons having as a common characteristic the placing of a device on the market under their own name. Where, in a situation such as that at issue in the main proceedings, a person purchases medical devices in a Member State, after they have been placed on the market in the European Union by their manufacturer, in order then to resell them in another Member State under the manufacturer’s name, without altering their packaging or their original presentation other than by affixing a label designating that person as responsible for placing the devices on the market and indicating its contact details and a code intended to identify those devices, that person cannot be considered to have repackaged or placed those devices on the market ‘under its own name’.
33 In such circumstances, the parallel importer of medical devices, as it is not marketing those devices under its own name, cannot be regarded as coming within the scope of Article 1(2)(f) of Directive 93/42. Consequently, that importer cannot be required to cause the devices in question to undergo a further conformity assessment procedure under Article 11 of that directive.
34 Even if it might be established that certain medical devices bearing a CE marking are liable to give rise to health or safety risks, it should be borne in mind that the presumption of conformity with the essential requirements of Directive 93/42 which derives from the CE marking may be reversed.
35 In particular, Article 8(1) of Directive 93/42 places Member States which have found that there are risks, linked to medical devices which have been certified as being in compliance with that directive, to the health and/or safety of patients or users or, where applicable, other persons under a duty to take all appropriate interim measures to withdraw those medical devices from the market, or to prohibit or restrict their being placed on the market or put into service. In those circumstances, the Member State concerned is required under that provision to notify the Commission immediately of the measures taken, indicating in particular the reasons for those measures. Under Article 8(2) of Directive 93/42, the Commission must in turn examine whether those interim measures are justified and, where that is found to be indeed the case, it must immediately inform the Member State which initiated the measures, as well as the other Member States, accordingly (see judgments of 14 June 2007, Medipac-Kazantzidis, C‑6/05, EU:C:2007:337, paragraph 46, and of 19 November 2009, Nordiska Dental, C‑288/08, EU:C:2009:718, paragraph 24).
36 That safeguard mechanism is complemented by the vigilance procedure provided for in Article 10 of Directive 93/42. This requires Member States to take the necessary steps to ensure that any information brought to their knowledge regarding incidents involving a Class I, IIa, IIb or III device, in particular ‘any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health’ is recorded and evaluated centrally and to ensure that they immediately inform the Commission of measures that have been taken or are contemplated in order to minimise the recurrence of those incidents.
37 Furthermore, by virtue of Article 14b of Directive 93/42, concerning particular health monitoring measures, where a Member State takes the view - in relation to a given product or group of products - that, in order to ensure protection of the health and safety of patients and/or to ensure that public health requirements are observed, the availability of such products should be prohibited, restricted or made subject to particular requirements, it may also take any necessary and justified transitional measures. The Member State concerned is then required to inform the Commission and all the other Member States accordingly, setting out the reasons for its decision.
38 The combination of these procedures for safeguarding, vigilance and health surveillance thus ensures protection for the health and safety of persons, while at the same time limiting the adverse effects on the free movement of goods which would be entailed by the application of national measures requiring the importer to carry out an assessment as to the conformity of the alterations which it makes to the labelling of a medical device already bearing a CE marking.
39 In the light of the foregoing considerations, the answer to the question referred is that Article 1(2)(f) and Article 11 of Directive 93/42 must be interpreted as not requiring a parallel importer of a medical device, such as that at issue in the main proceedings, which bears a CE marking and which has been subjected to a conformity assessment within the meaning of that Article 11, to carry out a further assessment designed to certify the conformity of the information allowing its identification which that parallel importer adds to the labelling of that device with a view to that device being placed on the market of the Member State of importation.
40 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national 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.