1. 

A manufacturer subjects test strips for use with an in vitro diagnostic medical device to a conformity assessment in one Member State. The labelling and instructions for use are in the language of that Member State. The test strips are approved and receive CE marking. Its distribution company in another Member State markets the same test strips there, with a label and instructions for use in the language of that second Member State. A parallel distributor buys the test strips in the first Member State with labelling and instructions for use in the language of that Member State, but adds product information on the outer packaging and encloses instructions for use that correspond word-for-word to the instructions enclosed with the test strips distributed by the manufacturer’s distribution company in the second Member State. It then distributes the test strips on the market of that second Member State. The distribution company challenges the lawfulness of its competitor’s activity, arguing that the parallel distributor is acting as a ‘manufacturer’ within the meaning of Article 9 of the Directive on in vitro diagnostic medical devices (‘the Directive’) ( 2 ) and that a new or supplementary conformity assessment procedure is therefore required for that distribution activity. This reference from the Bundesgerichtshof (Federal Court of Justice, Germany) offers the Court its first opportunity to interpret the Directive, which aims both to remove barriers to the free movement within the single market of devices bearing the CE marking and to ensure a high level of health protection.

2.

The Directive harmonises national rules regarding the safety, health protection and performance, characteristics and authorisation procedures for in vitro diagnostic medical devices and lays down such requirements as are necessary and sufficient to ensure free movement of the products falling within its scope under the best safety conditions. ( 3 ) One of the directive’s main objectives is to ensure that in vitro diagnostic medical devices provide patients, users and third parties with a high level of health protection and attain the performance levels originally attributed to them by the manufacturer. ( 4 )

3.

Article 1 of the Directive provides:

‘1.   This Directive shall apply to in vitro diagnostic medical devices …

2.   For the purposes of this Directive, the following definitions shall apply:

…

…

…

…

…’

4.

Pursuant to Article 2, Member States must take all necessary steps to ensure that devices may be placed on the market and/or put into service only if they comply with the requirements laid down in the Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose. To this end, Member States are required to monitor the security and quality of these devices.

5.

In accordance with Article 3, in vitro diagnostic medical devices must meet the essential requirements set out in Annex I which apply to them, taking account of their intended purpose.

6.

Under part A, section 1, of Annex I (‘Essential requirements’), in vitro diagnostic medical devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise, directly or indirectly, the clinical condition or the safety of the patients, the safety or health of users or, where applicable, other persons, or the safety of property. Any risks which may be associated with their use must be acceptable when weighed against the benefits to the patient and be compatible with a high level of protection of health and safety.

7.

Pursuant to part B, section 8.1, of Annex I, each device must be accompanied by the information necessary for its safe and proper use, taking into account the training and knowledge of the potential users, and identify the manufacturer. ( 6 ) This information comprises the data on the label and the instructions for use. ( 7 ) For devices for self-testing, the label and instructions for use must include a translation into the official language(s) of the Member State in which the device for self-testing reaches its final user. ( 8 )

8.

Article 4 of the Directive provides:

‘1.   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 … if these devices have undergone conformity assessment in accordance with Article 9.

…

4.   Member States may require the information to be supplied pursuant to Annex I, part B, section 8 to be in their official language(s) when a device reaches the final user.

…’

9.

It follows from Article 9(3) read in conjunction with the ninth indent of List B in Annex II that the manufacturer of self-testing devices for the measurement of blood sugar must, for the purposes of affixing the CE marking, follow either the procedure relating to the EC declaration of conformity set out in Annex IV (full quality assurance) or the procedure relating to the EC-type examination set out in Annex V, coupled with the procedure relating to EC verification set out in Annex VI, or the procedure relating to the EC declaration of conformity set out in Annex VII (production quality assurance).

10.

Article 9(11) requires the records and correspondence relating to conformity assessment procedures to be in an official language of the Member State in which the procedures are carried out and/or in another EU language acceptable to the notified body.

11.

Article 11 (‘Vigilance procedure’) provides in particular:

‘1.   Member States shall take the necessary steps to ensure that any information brought to their knowledge, in accordance with the provisions of [the] Directive, regarding the incidents mentioned below involving devices bearing the CE marking is recorded and evaluated centrally:

…

3.   After carrying out an assessment, if possible together with the manufacturer, Member States shall … immediately inform the Commission and other Member States of the incidents referred to in paragraph 1 for which appropriate measures, including possible withdrawal, have been taken or are contemplated.’

12.

Article 15(1) requires the Member States to notify the Commission and other Member States of the bodies which they have designated for carrying out the tasks pertaining to the procedures referred to in Article 9 and the specific tasks for which the bodies have been designated.

13.

Article 16(1) states that devices, other than devices for performance evaluation, considered to meet the relevant essential requirements set out in Annex I must bear the CE conformity marking when they are placed on the market.

14.

The German Law on medical products (Medizinproduktegesetz) and the German Medical Products Regulations (Medizinprodukte-Verordnung) implement, in particular, Articles 2, 3 and 16 of the Directive. Thus, in accordance with the first sentence of paragraph 6(1) of the German Law on medical products, in vitro diagnostic medical devices may be placed on the market in Germany only if they bear the CE marking. Under paragraph 6(2), medical products may receive the CE marking only if the essential requirements applicable to them have been satisfied. Paragraph 5(2) of the German Medical Products Regulations requires products intended for the measurement of blood sugar to be subject to one of the conformity assessment procedures referred to in Article 9(3) of the Directive.

15.

Roche Diagnostics GmbH (‘Roche’), a subsidiary of Hoffmann-La Roche AG, manufactures test strips for diabetics for use with its electronic blood sugar measurement devices, in order to enable them to self-test their blood sugar levels. Before placing the test strips on the market, under the designations ‘Accu-Chek Aviva’ and ‘Accu-Chek Compact’, Roche submitted those products to a conformity assessment by a notified body in the United Kingdom, in accordance with Article 9 of the Directive. The label and instructions for use were thus in English. The test strips received CE marking and could therefore in principle move freely within the European Union. Nothing in the material submitted to the Court suggests that the CE marking was (for whatever reason) wrongly affixed to the products or that the conformity assessment was in some way deficient or flawed.

16.

Roche Diagnostics Deutschland GmbH (‘Roche Deutschland’), a distribution company of Roche, markets Accu-Chek Aviva and Accu-Chek Compact in Germany, with labelling and instructions for use in German. Thus, when marketed in Germany the test strips have information in German on the outer packaging and instructions for use in German enclosed in the sales packaging. The test strips boxes also contain a control solution for verifying the accuracy of the blood sugar measurement device. Thus, before measuring his blood sugar level, the patient places a drop of the control solution on a test strip and inserts it into the measurement device. The value measured is compared with the threshold values indicated on the box of test strips. If the value measured is outside the threshold values, it means that the blood sugar measurement device is not sufficiently accurate. The blood sugar measurement devices which Roche Deutschland markets in Germany use either ‘mmol/l’ (millimoles/litre) or ‘mg/dl’ (milligrams/decilitre) as the unit of measurement. ( 9 ) The threshold values on test strip boxes which it markets in that Member State are therefore indicated in both units of measurement. By contrast, the same blood sugar measurement devices and test strips marketed by Roche in the United Kingdom use ‘mmol/l’ as the only unit of measurement.

17.

Servoprax GmbH (‘Servoprax’) distributed in Germany Accu-Chek Aviva and Accu-Chek Compact that had been manufactured for the United Kingdom market. On the new labels in German which it attached to the outer packaging of these products, Servoprax identified itself as their ‘importer and distributor’ in Germany. The labels attached to the outer packaging of Accu-Chek Aviva also contained information in German describing the product, its purpose and how to use it. Servoprax included with all products a document in German corresponding word-for-word to the instructions for use provided with the test strips distributed by Roche Deutschland in Germany. Between June 2010 and the autumn of that year, the Accu-Chek Aviva which Servoprax distributed in Germany only mentioned ‘mmol/l’ as the unit of measurement.

18.

Roche Deutschland challenged Servoprax’s distribution activity. It argued that Servoprax could not sell the Accu-Chek Aviva and Accu-Chek Compact test strips it had purchased in the United Kingdom on the German market without a new or supplementary conformity assessment procedure under Article 9 of the Directive. It therefore served a warning on Servoprax in respect of that parallel distribution. Without prejudice to its legal position, Servoprax subjected those products to a new conformity assessment procedure carried out by a notified body in the Netherlands and received the certification applied for on 13 December 2010.

19.

Roche Deutschland initiated judicial proceedings in Germany against Servoprax seeking the provision of information, the payment of compensation and the reimbursement of legal costs. The judgment rejecting that action at first instance was reversed on appeal in respect of distribution which took place prior to 13 December 2010. Servoprax appealed to the Bundesgerichtshof (Federal Court of Justice).

20.

The Bundesgerichtshof (Federal Court of Justice) considers that the outcome of that appeal turns on the interpretation of Articles 1(2)(f), 2, 3, 4(1), 9(3) and 16 of, and Annexes I and IV to VII to, the Directive. It therefore stayed the proceedings and requested a preliminary ruling on the following questions:

‘In the case of an in vitro diagnostic medical device for self-testing blood sugar levels which has undergone a conformity assessment by the manufacturer in accordance with Article 9 of [the Directive] in Member State A (specifically: in the United Kingdom), which bears the CE marking of conformity in accordance with Article 16 of that directive and which meets the essential requirements set out in Article 3 of, and Annex I to, that directive, is a third party required to subject that device to a new or additional conformity assessment in accordance with Article 9 of [the Directive] before it places the device on the market in Member State B (specifically: in the Federal Republic of Germany) in packaging which contains instructions in the official language of Member State B, which differs from the official language of Member State A (specifically: German as opposed to English) and the instructions for the use of which are enclosed in the official language of Member State B rather than in that of Member State A?

Does it make any difference in this case whether the instructions for use enclosed by the third party correspond word-for-word to the information which the manufacturer of the device uses for the purpose of distribution in Member State B?’

21.

Written observations were submitted by Servoprax, Roche Deutschland, the German and Lithuanian Governments and the European Commission. With the exception of the Lithuanian Government, the same parties made oral submissions at the hearing on 6 April 2016.

22.

It is common ground that test strips for the self-testing of blood sugar levels are devices for self-testing within the meaning of Article 1(2)(d) of the Directive and must therefore undergo conformity assessment in accordance with Article 9(3) of that directive. ( 10 )

23.

The Directive pursues a double objective, as it seeks both to ensure free movement of in vitro diagnostic medical devices within the internal market and to ensure that those devices provide patients, users and third parties with a high level of health protection. ( 11 )

24.

The system of CE marking of conformity set out in Article 16 of the Directive reflects both those objectives. On the one hand, devices considered to meet the essential requirements in Annex I must bear the CE marking of conformity when they are placed on the market. Both conformity assessment procedures to which that provision refers involve intervention by a notified body. They also entail an examination of the label and instructions for use. ( 12 )

25.

On the other hand, there is a reward for fulfilling those formalities. Once the devices have undergone conformity assessment and thus bear the CE marking, ( 13 ) Member States may not create any obstacle to placing them on the market or putting them into service within their territory, ( 14 ) subject only to the safeguard clause in Article 8 and the vigilance procedure in Article 11 of the Directive. ( 15 )

26.

The questions referred to the Court essentially ask for guidance on the following issue. Where a parallel distributor has purchased products covered by the Directive that have already undergone a conformity assessment and bear the CE conformity marking and, in order to market them in another Member State, attaches a new label and encloses instructions for use in the official language of that Member State which are materially identical to what the manufacturer provides when it distributes its own products through its own distributor, is the parallel distributor required to put the CE-marked products it wishes to sell through a new or supplementary conformity assessment procedure before it can lawfully market them?

27.

The requirement laid down by Article 9 of the Directive to submit any device covered by that directive to a conformity assessment procedure only applies to ‘the manufacturer’ of that device. The meaning of that concept is therefore central to providing an answer to that question.

28.

Article 9(11) of the Directive requires the records and correspondence relating to the conformity assessment procedures to be ‘in an official language of the Member State in which the procedures are carried out and/or in another [EU] language acceptable to the notified body’ (emphasis added). Therefore, as the main proceedings indeed illustrate, a conformity assessment procedure does not concern different language versions of the label and instructions for use of a device with a view to its being marketed in various Member States. Requiring every notified body to be able to carry out conformity assessment procedures in the various official languages of all the Member States in which the manufacturer intended to market a new device would be inconsistent with the plain wording of Article 9(11). It would also be virtually impossible to implement in practice.

29.

The Directive does not moreover require a manufacturer whose device has already undergone conformity assessment by a notified body in one Member State to subject that device to new or additional conformity assessment in another Member State where he also intends to market it, even where that Member State uses a different official language. It follows from Article 4(1) that, once a device has undergone conformity assessment and bears the CE marking, Member States may not create any obstacle to placing it on the market or putting it into service in their territory, subject only to the safeguard clause in Article 8 and the vigilance procedure in Article 11. It would plainly be incompatible with that free movement objective to interpret Article 9 of the Directive as requiring the manufacturer to subject a CE-marked device to a new or supplementary conformity assessment every time he wished to market it in a Member State with a different official language than that in which the original conformity assessment was carried out.

30.

The Directive however strikes a careful balance between the free movement objective and the health protection objective. Thus, it follows from Article 4(4) that the free movement rule under Article 4(1) is without prejudice to the possibility for Member States to require, inter alia, that the information needed to use a device safely and properly or the compulsory information on the label ( 16 ) be given in their official language(s) when the device reaches the final user. The directive itself converts that option into an obligation for devices for self-testing. Under Article 3 read together with the sixth subparagraph of part B, section 8.1, of Annex I, a manufacturer marketing a self-testing device is required to provide with it a translation of the label and instructions for use into the official language(s) of the Member State(s) in which the device in question reaches its final user. ( 17 ) Again, that does not involve a new or supplementary conformity assessment procedure.

31.

Do the same principles apply when an independent distributor markets devices which have received CE marking following a conformity assessment procedure in one Member State in a different Member State and provides a translation of the label and the instructions for use into the official language of the second Member State?

32.

In my view, the answer is ‘yes’. That results first of all from a reading of various provisions of the Directive taken together.

33.

It appears from the definition in Article 1(2)(f), first subparagraph, of the Directive that the act of placing a product on the market under one’s own name serves to identify who is a ‘manufacturer’. ( 18 ) The same holds true for Article 1(2)(f), second subparagraph, which subjects natural or legal persons who assemble, package, process, fully refurbish and/or label one or more ready-made products and/or assign them to their intended purpose to the same obligations as ‘manufacturers’ only to the extent that they place products on the market under their own name.

34.

According to Article 1(2)(i), a device is placed on the market once it is first made available with a view to distribution and/or use in the internal market. Where a manufacturer, under his own name, sells devices to an independent economic operator who intends to distribute them in another Member State, the devices are first placed on the market by the manufacturer, not by the independent economic operator.

35.

I therefore reject Roche Deutschland’s submission that, when Servoprax added a label and instructions for use in German to the devices for self-testing which it distributed in Germany, Servoprax acted as a ‘manufacturer’ placing those devices on the German market. It appears clear from the material available to the Court that Servoprax did not place those devices on the market under its own name but rather sold them in Germany after they had already been ‘placed on the market’ in another Member State. It is true that Servoprax clearly identified itself as the importer and distributor of the devices in Germany. That does not imply however that it marketed them in that Member State ‘under its own name’, which would have required that Servoprax held itself out to the purchasers as the devices’ manufacturer. ( 19 )

36.

Consequently, in circumstances such as those in the main proceedings, the distributor cannot be regarded as either a ‘manufacturer’ within the meaning of Article 1(2)(f), first subparagraph, of the directive or a person subject to the same obligations as manufacturers pursuant to Article 1(2)(f), second subparagraph, of that Directive. ( 20 ) Accordingly, such a distributor is not required to subject the devices which it sells in the European Union to a new or supplementary conformity assessment procedure in accordance with Article 9 of the Directive.

37.

That corresponds in essence to the Commission’s recommendation in its Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices (the ‘proposal for a new regulation’). ( 21 ) The Commission there suggests that a distributor should be subject to the obligations incumbent on manufacturers (including regarding conformity assessment) ( 22 ) if he modifies a device already placed on the market or put into service in such a way that compliance with requirements applicable to that device pursuant to the regulation may be affected. ( 23 ) However, that does not apply where the distributor merely provides a translation of the label and instructions for use supplied by the manufacturer relating to a device already placed on the market and of further information which is necessary in order to market the product in the relevant Member State. ( 24 )

38.

In my view it is immaterial whether the instructions for use which the distributor attaches to the devices marketed in the Member State of distribution do or do not correspond word-for-word to the instructions for use which the manufacturer provides with those devices in that Member State. That has no bearing on whether the distributor places the device on the market in his own name. It is therefore irrelevant for the purposes of ascertaining whether he is required to subject the device to a new conformity assessment in accordance with Article 9 of the Directive.

39.

Furthermore, the conclusion that I have reached does not compromise the Directive’s objective of ensuring a high level of health protection.

40.

According to Article 3 of the Directive, devices must meet the essential requirements set out in Annex I which are applicable to them, taking into account their intended purpose. ( 25 ) Consequently, in a situation such as that in the main proceedings, the distributor has to ensure that the instructions for use and the label of the device for self‑testing which it sells in a Member State contain all the information needed to use the device safely and properly and include a translation into the official language(s) of that Member State. ( 26 ) This echoes the requirements applicable to the manufacturers themselves when they extend their marketing of a device for self-testing to other Member States in the European Union. ( 27 )

41.

The various enforcement mechanisms are such as to encourage compliance with those requirements.

42.

Thus, a distributor who is in breach could be held responsible for any damage caused by its negligence and, consequently, be required to compensate victims (private enforcement).

43.

In addition, Article 2 of the Directive requires Member States to ensure that devices comply with the security and quality requirements which it lays down when the devices are placed on the market. In my view, having regard to the Directive’s objective of ensuring a high level of health protection, that involves monitoring the security and quality of devices which independent distributors (such as Servoprax) sell on their territory, including as regards the quality and accessibility of the information needed to use the devices safely and properly (public enforcement). ( 28 )

44.

That monitoring duty is supplemented by the vigilance procedure set out in Article 11 of the Directive, which requires Member States to record and evaluate centrally any information brought to their knowledge concerning, inter alia, ‘any inadequacy in the labelling or the instructions for use’ of a device bearing the CE marking which is liable to threaten the life of a patient, user or other persons or to lead to a serious deterioration in their state of health, and to inform the Commission (and other Member States) immediately if appropriate measures (including possible withdrawal of the device from the market) have been taken or are contemplated. As I see it, that vigilance procedure should be activated if a Member State becomes aware that a distributor has sold an in vitro diagnostic medical device on its territory with a label and/or instructions for use that are liable to result in a serious risk for human health and safety.

45.

That said, I cannot agree with the Commission when it contends that, in a situation such as that in the main proceedings, the distributor is required to give prior notice to the manufacturer of the in vitro diagnostic medical device before repackaging it and putting it on sale, so that the manufacturer can verify whether the labelling and information provided with the device comply with all applicable requirements. ( 29 ) The Commission here sought to draw an analogy between CE conformity marking and the protection due to trade mark owners when their trade-marked pharmaceutical products give rise to parallel distribution within the internal market. ( 30 ) The Commission also submits that this corresponds in essence to what is envisaged in the proposal for a new regulation.

46.

I see no basis in EU law as it stands today for a pre-notification procedure such as that set out in the previous point.

47.

The trade mark case-law to which the Commission refers cannot lead to such a result by analogy. The pre-notification and pre-authorisation procedure which developed through that case-law aims to reconcile free movement of pharmaceutical products with the legitimate interest of trade mark owners to be protected in particular against repackaging by parallel distributors such as either to affect the original condition of the product or to damage the reputation of the trade mark. ( 31 ) That legitimate interest results from the specific subject matter of the trade mark, which is, inter alia, to guarantee to the owner that he has the exclusive right to use that trademark for the purpose of putting a product on the market for the first time and therefore to protect him against competitors wishing to take advantage of the status and reputation of the trade mark by selling products bearing it illegally. ( 32 ) Whilst the Court concluded that, as a result of the free movement of goods, the trade mark owner might not rely on his rights as owner in order to oppose the marketing under his trade mark of products repackaged by a parallel importer, it also deemed it necessary to protect the owner against any misuse of his trade mark. ( 33 )

48.

CE marking on a product confers no such exclusive right on the product’s manufacturer. The purpose of CE marking is different. As is clear from Article 30(3) of Regulation (EC) No 765/2008, ( 34 ) affixing CE marking to a product merely indicates that the manufacturer ‘takes responsibility for the conformity of the product with all applicable requirements set out in the relevant Community harmonisation legislation providing for its affixing’, including thus, where appropriate, requirements under the Directive on in vitro diagnostic medical devices. ( 35 ) That commitment does not confer on the manufacturer an exclusive right justifying requiring an independent distributor, in a situation such as that in the main proceedings, to obtain the manufacturer’s authorisation before marketing the device in the Member State of distribution. That conclusion is of course without prejudice to the duties which I have identified at point 40 of this Opinion and which (according to the law already in force) bear on the distributor in such circumstances.

49.

Finally, the parties have devoted some attention to the difference in the units of measurement relating to the threshold values for the control solution appearing on the Accu-Chek Aviva marketed by Roche Deutschland on the German market (that is to say both mmol/l and mg/dl) and on the same product sold by Servoprax in that Member State from June 2010 to the autumn of that year (mmol/l only). At the hearing, Roche Deutschland confirmed in essence that the unit of measurement ‘mg/dl’ was added to the test strips which it sold in Germany in order to take into account usages and legal requirements in that Member State. It also indicated that that unit of measurement formed part of the conformity assessment conducted by the notified body in the United Kingdom, in addition to ‘mmol/l’. Roche Deutschland argued on that basis that patient safety might be compromised by Servoprax’s activities and that, for that reason, a supplementary conformity assessment was necessary.

50.

I do not agree.

51.

First of all, I note that Roche Deutschland’s submission that it is not legal to market Accu-Chek Aviva and Accu-Chek Compact in Germany only with ‘mmol/l’ as a unit of measurement was flatly contradicted by the German Government at the hearing. There is moreover nothing in the material before the Court to suggest that such a prohibition exists in Germany.

52.

Next, in any event the devices Servoprax distributed on the German market bore the CE marking and had undergone conformity assessment in accordance with Article 9. The manufacturer of those devices thus took responsibility for their conformity with all applicable requirements under the Directive. ( 36 ) Accordingly, the devices could be marketed throughout the European Union without a new or supplementary conformity assessment, subject (in particular) to compliance with the requirements in the first, second and sixth subparagraphs of part B, section 8.1, in Annex I to the Directive. As I have explained, a distributor acting in breach of those requirements would run the risk of a civil action and might also be subject to enforcement measures by the competent national authorities. ( 37 )

53.

At the hearing, Roche Deutschland also sought to rely on Laboratoires Lyocentre. ( 38 ) The Court there examined whether the classification of a product in one Member State as a medical device bearing the CE marking, in accordance with Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, ( 39 ) precluded the competent authorities of another Member State from classifying the same product, on the basis of pharmacological, immunological or metabolic action, as a medicinal product within the meaning of Article 1(2)(b) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. ( 40 ) Whilst answering ‘no’ to that question, the Court emphasised that, prior to reclassifying the product, the competent national authorities had first to apply the procedure for wrongly affixed CE marking set out in Article 18 of Directive 93/42. By contrast, the present case is not one in which the authorities of a Member State take the view that CE marking has been wrongly affixed on a device marketed on that Member State’s territory, or that it has been affixed in accordance with the Directive on in vitro diagnostic medical devices on a product that is not in fact covered by that directive. ( 41 ) On the contrary, there is no suggestion that CE marking has been wrongly affixed or affixed inappropriately on the test strips at issue in the main proceedings. ( 42 )

54.

In the light of the foregoing considerations, I suggest that the Court should rule as follows in answer to the questions raised by the Bundesgerichtshof (Federal Court of Justice, Germany):