CELEX: 62015CJ0277
Reference for a preliminary ruling
Approximation of laws
In vitro diagnostic medical devices
Directive 98/79/EC
Parallel imports
Translation by the importer of the information and instructions for use provided by the manufacturer
Supplementary conformity assessment procedure

This request for a preliminary ruling concerns the interpretation of 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
).
The request has been made in proceedings between Servoprax and Roche Diagnostics Deutschland GmbH (‘RDD’), concerning the conditions for placing on the German market
in vitro
diagnostic medical devices imported from another Member State.
Legal context
Recitals 3, 5 and 6 of Directive 98/79 are worded as follows:
‘(3)
… the harmonisation of national legislation is the only means of removing such barriers to free trade and of preventing new barriers from arising; … this objective cannot be achieved in a satisfactory manner by other means by the individual Member States; … this Directive lays down only such requirements as are necessary and sufficient to ensure, under the best safety conditions, free movement of the
in vitro
diagnostic medical devices to which it applies;
...
(5)
…
in vitro
diagnostic medical devices should 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; … therefore, maintenance or improvement of the level of health protection attained in the Member States is one of the main objectives of this Directive;
(6)
… in accordance with the principles set out in the [Council resolution of 7 May 1985 on a new approach to technical harmonisation and standards (
OJ 1985 C 136, p. 1
)] rules regarding the design, manufacture and packaging of relevant products must be confined to the provisions required to meet the essential requirements; … because they are essential, such requirements should replace the corresponding national provisions; … the essential requirements, including requirements to minimise and reduce risks, should be applied with discretion, taking into account the technology and practice at the time of design and technical and economic considerations compatible with a high level of protection of health and safety’.
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 a device 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;
...’
Article 2 of that directive, headed ‘Placing on the market and putting into service’, provides:
‘Member States shall 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 this Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose. This involves the obligation of Member States to monitor the security and quality of these devices. This Article applies also to devices made available for performance evaluation.’
Article 3 of that directive, headed ‘Essential requirements’, provides:
‘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.’
Article 4 of Directive 98/79, headed ‘Free movement’, 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 provided for in Article 16 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.
Provided that safe and correct use of the device is ensured, Member States may authorise the information referred to in the first subparagraph to be in one or more other official [EU] language(s).
In the application of this provision, Member States shall take into account the principle of proportionality and, in particular:
(a)
whether the information can be supplied by harmonised symbols or recognised codes or other measures;
(b)
the type of user anticipated for the device.
...’
Article 9(3) and (11) of that directive, that article being headed ‘Conformity assessment procedures’ provides:
‘3.   For all devices referred to in List B in Annex II other than those intended for performance evaluation, the manufacturer shall for the purposes of affixing the CE marking, follow either:
(a)
the procedure relating to the EC declaration of conformity set out in Annex IV (full quality assurance) or;
(b)
the procedure relating to EC type-examination set out in Annex V couplet with:
(i)
the procedure relating to EC verification set out in Annex VI, or
(ii)
the procedure relating to the EC declaration of conformity set out in Annex VII (production quality assurance).
…
11.   The records and correspondence relating to the procedures referred to in paragraphs 1 to 4 shall 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.’
Article 16 of that directive, headed ‘CE marking’, provides:
‘1.   Devices, other than devices for performance evaluation, 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.
2.   The CE marking of conformity, as shown in Annex X, must appear in a visible, legible and indelible form on the device, where practicable and appropriate, and on the instructions for use. The CE marking of conformity must also appear on the sales packaging. The CE marking shall be accompanied by the identification number of the notified body responsible for implementation of the procedures set out in Annexes III, IV, VI and VII.
3.   It is prohibited to affix marks or inscriptions which are likely to mislead third parties with regard to the meaning or the graphics of the CE marking. Any other mark may be affixed to the device, to the packaging or to the instruction leaflet accompanying the device provided that the visibility and legibility of the CE marking is not thereby reduced.’
Devices for self-diagnosis for measuring blood sugar are covered by List B in Annex II to Directive 98/79, Annex II being headed ‘List of devices referred to in Article 9(2) and (3).’
Annex I to Directive 98/79, headed ‘Essential requirements’, provides in Section A.1, that section being headed ‘General requirements’:
‘The 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.’
Under point 8 of Section B of Annex I to Directive 98/79, that section being headed ‘Design and Manufacturing Requirements’:
‘Information supplied by the manufacturer
8.1.
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 data on the label and in the instructions for use.
As far as practicable and appropriate, the information needed to use the device safely and properly must be set out on the device itself and/or, where appropriate, on the sales packaging. If individual full labelling of each unit is not practicable, the information must be set out on the packaging and/or in the instructions for use supplied with one or more devices.
Instructions for use must accompany or be included in the packaging of one or more devices.
In duly justified and exceptional cases no such instructions for use are needed for a device if it can be used properly and safely without them.
The decision whether to translate the instructions for use and the label into one or more languages of the European Union shall be left to the Member States, except that, for devices for self-testing, the instructions for use and the label must include a translation into the official language(s) of the Member State in which the device for self-testing reaches its final user.
...’
Annex IV to Directive 98/79, headed ‘ EC Declaration of Conformity’ (Full quality assurance system), provides in point 1 :
‘The manufacturer must ensure application of the quality system approved for the design, manufacture and final inspection of the devices concerned, as specified in section 3, and is subject to audit as laid down in section 3.3 and to the surveillance as specified in section 5. In addition, the manufacturer must follow, for devices covered by Annex II, List A, the procedures laid down in sections 4 and 6.’
Under point 1 of Annex V to Directive 98/79, headed ‘EC Type-examination’:
‘EC type-examination is the part of the procedure whereby a notified body ascertains and certifies that a representative sample of the production envisaged fulfils the relevant provisions of this Directive.’
The request to reopen the oral procedure
By document lodged at the Court’s Registry on 12 July 2016, RDD requested that a further hearing be set for oral argument and, in the event that the oral part of the procedure had already been declared closed, that the Court order the oral part of the procedure to be reopened. In support of that request, RDD claims, in essence, that the Opinion delivered by the Advocate General is based on errors of fact with respect to the description of its business and that of Roche Diagnostics GmbH, its parent company.
That request was made after the Advocate General had delivered her Opinion and, therefore, after the oral part of the procedure was declared closed in accordance with Article 82(2) of the Court’s Rules of Procedure. The request must therefore be understood as a request to reopen the oral procedure.
It should be noted that the Court may, at any time, after hearing the Advocate General, order that the oral procedure be reopened, in accordance with Article 83 of its Rules of Procedure, in particular if it considers that it lacks sufficient information or that the case must be dealt with on the basis of an argument that has not been debated by the parties or the interested persons referred to in Article 23 of the Statute of the Court of Justice of the European Union.
In the present case, the Court, after hearing the Advocate General, considers that it has all the information necessary to answer the question raised by the referring court and that the case does not have to be decided in the light of a new fact of such a nature as to have a decisive bearing on its decision or of an argument which has not been debated before it.
That being the case, the request is rejected.
The dispute in the main proceedings and the questions referred for a preliminary ruling
RDD markets two types of test strips manufactured by Roche Diagnostics for use for self-testing of blood sugar. Those products were subject to a conformity assessment undertaken by a notified body in the United Kingdom and bear a CE marking.
In Germany, RDD sells those products with labelling and instructions for use in German and, as the units of measurement, ‘mmol/l’ and ‘mg/dl’. Roche Diagnostics places those products on the United Kingdom market using, as the sole unit of measurement, ‘mmol/l’.
Servoprax purchases in the United Kingdom the two types of test strips manufactured by Roche Diagnostics in order to re-sell them in Germany. Servoprax adds to those products a label and instructions for use in German. In the period between the month of June and the autumn of 2010, the threshold values for the devices marketed by Servoprax were stated solely in ‘mmol/l’, as applies for those sold in the United Kingdom.
RDD served notice on Servoprax that it could not market those products in Germany unless it submitted them for a supplementary conformity assessment. Servoprax then made use of a notified body established in the Netherlands. On 13 December 2010 that body certified the products concerned.
RDD brought an action before the Landgericht (Regional Court, Germany) seeking primarily an order that Servoprax should pay damages for the loss sustained due to the sale of the products concerned prior to 13 December 2010. That action was dismissed.
RDD brought an appeal against that decision. The appeal court held that Servoprax had contravened the national legislation on the labelling of
in vitro
diagnostic medical devices.
An appeal on a point of law having been brought before it by Servoprax, the referring court considers that the outcome of the dispute depends on the interpretation of Directive 98/79. That court considers that RDD’s claims should be upheld if Servoprax, in marketing the products concerned prior to 13 December 2010, was in breach of the national provisions on the labelling of
in vitro
diagnostic medical devices.
The referring court notes that it is stated in point 8.1 of Annex I.B to Directive 98/79 that one of the essential requirements prescribed in Article 3 of that directive is that each device must be accompanied by the information that is needed to use it safely and properly, taking account of the training and knowledge of the potential users, and that serves to identify the manufacturer. That information comprises the data on the labelling and in the instructions for use, which must include a translation into the official language or languages of the Member State in which the device to be used for self-diagnosis reaches the final user.
Since the labelling and instructions for use are covered by the conformity certification and examination procedures laid down in Annexes IV and V to Directive 98/79 and the information forms part of the essential requirements, within the meaning of Article 3 of, and Annex I to, that directive, the referring court considers that a parallel importer may not place on the market in Germany
in vitro
diagnostic medical devices for self-testing of blood sugar levels that have been relabelled and supplied with German-language instructions for use unless a supplementary conformity assessment has taken place.
In the view of the referring court, the exception provided for in Article 1(2)(f) of Directive 98/79, for the benefit of a person who, while not a manufacturer, assembles or adapts, to their intended purpose, devices already on the market for an individual patient, is not applicable in this case. A broad interpretation of that exception would come up against the fact that the reproduction of the labelling and the instructions for use of a corresponding product, without any checks by a notified body, could endanger the health of patients. In this case, the products at issue marketed in Germany contain as the sole unit of measurement only ‘mmol/l’. Patients would therefore be required to make a conversion into ‘mg/dl’ in order to use those test strips in a device that contained only measurements in ‘mg/dl’.
According to the referring court, the fact that the instructions for use attached by Servoprax correspond word for word to that used by RDD should not be a point in the parallel importer’s favour. In the course of the additional procedure, the conformity review could be restricted to checking whether the information on the labelling and in the instructions for use do in fact correspond to the information that has already been the subject of the assessment carried out by the manufacturer.
In those circumstances the Bundesgerichtshof (Federal Court of Justice, Germany) decided to stay the proceedings before it and to refer the following questions to the Court for a preliminary ruling:
‘(1)
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 Directive 98/79/EC 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 supplementary conformity assessment in accordance with Article 9 of Directive 98/79/EC 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?
(2)
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?’
Consideration of the questions referred for a preliminary ruling
By its two questions, which can be examined together, the referring court seeks, in essence, to ascertain whether Article 9 of Directive 98/79 must be interpreted as meaning that it requires a parallel importer of a self-diagnosis device for the measurement of blood sugar, which bears a CE marking and which has been the subject of a conformity assessment by a notified body, to undertake a further assessment to obtain certification of the conformity of the labelling and instructions for use of that device because of their translation into the official language of the Member State of importation.
In order to answer the question referred, it is useful to recall the obligations imposed by Directive 98/79 on manufacturers and parallel importers for the purposes of assessment of the conformity of a device to be used for self-diagnosis, such as that at issue in the main proceedings.
In that regard, it must be noted that the objective of Directive 98/79, which constitutes a harmonisation measure adopted under Article 100A of the EC Treaty (later Article 95 EC), is to promote the free movement of
in vitro
diagnostic medical devices that conform to the requirements of that directive in order to replace the various laws, regulations and administrative measures in force in the Member States which create barriers to free trade.
Directive 98/79 harmonises the essential requirements which must be met by the
in vitro
diagnostic medical devices falling within the scope of that directive. 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.
To that effect, Article 16(1) of Directive 98/79 provides that all devices, other than those for performance evaluation, which are considered to meet the essential requirements referred to in Article 3 of that directive, 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 if those devices have undergone conformity assessment in accordance with Article 9 of that directive.
It therefore follows from those provisions that
in vitro
diagnostic devices the conformity of which with the essential requirements of Directive 98/79 has been certified and which bear a CE marking must be allowed to move freely throughout the European Union, and no Member State can impose a requirement that such a product should undergo a further conformity assessment procedure (see, by analogy, judgment of 14 June 2007, Medipac-Kazantzidis,
C‑6/05
,
EU:C:2007:337
, paragraph
). That is why Directive 98/79 makes no provision for any mechanism for the review of conformity that is additional to or that supplements the mechanisms provided for in Article 9 of that directive.
As regards the language requirements for the marketing of
in vitro
diagnostic devices, Article 9(11) of Directive 98/79 requires records and correspondence relating to the conformity assessment procedures to be written ‘in an official language of the Member State in which the procedure are carried out and/or in another language [of the European Union] acceptable to the notified body’. That provision therefore does not impose a requirement that the assessment records be written in each of the official languages of the Member States in which it is intended that an
in vitro
diagnostic device will be sold.
Article 4(4) of Directive 98/79 provides, however, that the Member States may require that, when a device reaches the final user, the information that is needed to ensure that the device can be used properly and safely, taking account of the training and knowledge of the potential users, and that serves to identify the manufacturer, should be written in their official languages. In the specific case of devices intended for self-diagnosis, that option is converted to an obligation. It follows from a combined reading of Article 4(4) of Directive 98/79 and the last subparagraph of point 8.1 of Annex I.B to that directive that a product of that kind must be accompanied by instructions for use and labelling in the official language or languages of the Member State in which the device reaches the final user.
It must be emphasised that the rules referred to in paragraphs 37 and 39 of this judgment apply without distinction to the manufacturer and to the parallel importer of an
in vitro
diagnostic device. The prohibition imposed on the Member States, not to require a further conformity assessment, concerns all the devices that bear a CE marking and that have been subject to a conformity assessment procedure in accordance with Article 9 of Directive 98/79. Likewise, the option for, or, in the case of devices intended for self-diagnosis, the obligation on, the Member States, to require that, when an
in vitro
diagnostic device reaches the final user, the information needed for the safe use of that device should be translated into the official language or languages of that Member State, applies to all devices, whether they are sold by the manufacturer or by a third party.
It follows from the foregoing that, while the Member States are obliged, in the case of a self-diagnosis device such as that at issue in the main proceedings, to require that information to be translated into their official languages, they cannot go so far as to require the importer of such a device, that bears a CE marking and that has undergone conformity assessment by a notified body, to submit that device to a notified body for an assessment of the conformity of alterations caused by that translation requirement.
The referring court asks nonetheless whether, as claimed by RDD, for reasons of patient safety, the parallel importer of an
in vitro
diagnostic medical device who adds a label and instructions for use written in the language of the Member State of importation should be treated in the same way as a manufacturer and, consequently, should undertake a supplementary conformity assessment.
However, as the Advocate General stated in point 27 of her Opinion, the obligation to undertake a conformity assessment laid down in Article 9 of Directive 98/79 is imposed solely on a manufacturer. As defined in Article 1(2)(f) of that directive, that concept means the person who places a device on the market under his own name. When a person purchases in a Member State
in vitro
diagnostic devices after they have been placed on the EU market by their manufacturer in order thereafter to re-sell them in another Member State, but makes no alteration to their original packaging or presentation other than to attach a label and instructions for use written in the official language(s) of the Member State of importation, that person cannot be regarded as having repackaged that device or having placed it on the market ‘under his own name’.
That being the case, the parallel importer of devices intended for self-diagnosis, such as those at issue in the main proceedings, unless he markets those devices under his own name, cannot be regarded as a ‘manufacturer’, within the meaning of Article 1(2)(f) of Directive 98/79. Consequently, that importer cannot be required to submit the devices concerned for a further conformity assessment procedure under Article 9 of that directive in order to certify the conformity of the alterations made to the labelling of that device and the instructions for its use as a result of their translation into the official language of the Member State of importation.
In any event, as regards the fears expressed by the referring court in relation to the failure of the devices imported by Servoprax to use both units of measurement (‘mmol/l’ and ‘mg/dl’) displayed on the devices sold in Germany by RDD, it must be stated that there is nothing in the documents submitted to the Court to indicate that such a presentation is contrary to German law. The German Government, at the hearing, moreover expressly denied the existence, under national law, of a prohibition on selling devices for measuring blood sugar that have ‘mmol/l’ as the sole unit of measurement.
If it were to be established that certain devices intended for use for self-diagnosis and bearing a CE marking, such as those at issue in the main proceedings, might compromise health or safety, it must be recalled that Directive 98/79, one of whose main objectives is, as stated in recital (5) thereof, the maintenance or improvement of the level of health protection attained in the Member States, provides for the adoption of safeguard measures. Article 8 of that directive imposes on Member States that have identified risks to the health and/or safety of patients, users or, where applicable, other persons, or the safety of property, the obligation to take all appropriate interim measures to withdraw those devices from the market, or 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 its decision.
That safeguard mechanism is complemented by the vigilance procedure provided for in Article 11 of Directive 98/79. That procedure requires Member States to take the necessary steps to ensure that any information brought to their knowledge regarding, inter alia, ‘any inadequacy in the labelling or the instructions for use [of devices bearing the CE marking] which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health’ should be immediately notified to the European Commission and to the other Member States and should be recorded and evaluated centrally.
The combination of those safeguard and vigilance procedures accordingly makes it possible to protect the health and safety of individuals, while limiting the adverse effects on the free movement of goods that would be entailed by the application of national measures requiring an importer to undertake a supplementary conformity assessment with respect to the alterations made to the labelling of a device and the instructions for its use in order to comply with the language requirements of the State of importation.
In that regard, the Commission submits, referring by analogy to the Court’s case-law on the application of trademark law to the repackaging of products, more specifically the judgment of 11 July 1996, Bristol-Myers Squibb and Others (
C‑427/93, C‑429/93 and C‑436/93
,
EU:C:1996:282
) and the order of 11 December 2002,
Merkur Chemical
(C‑134/00, not published,
EU:C:2002:743
), that a manufacturer may not object to the affixing by a parallel importer of a label or the attachment of a translation of the instructions for use, provided that that importer has taken the trouble to notify in advance that manufacturer of the placing of the repackaged product for sale, in order to enable the manufacturer to verify the accuracy of that information and to ensure the safety of the product and of patients. That verification would extend to units of measurement and would offer an effective answer to concerns in relation to the health of patients.
However, as stated by the Advocate General in point 46 of her Opinion, there is no legal basis in EU law as it stands for the mechanism of advance notification thus advocated by the Commission. There is no provision in Directive 98/79 from which it can be inferred that such a mechanism was established, even implicitly, by the EU legislature.
Further, it would be contrary to the structure and the objectives of Directive 98/79 to accord to the manufacturer of an
in vitro
diagnostic device the right to be notified in advance of a parallel import solely because of the fact that that device bears a CE marking. A CE marking does not confer on the manufacturer, who affixes it to an
in vitro
diagnostic device after having submitted that device for a conformity assessment in accordance with Article 9 of Directive 98/79, any exclusive right comparable to that provided by a trademark to its proprietor.
In the light of the foregoing, the answer to the question referred is that Article 9 of Directive 98/79 must be interpreted as meaning that it does not require a parallel importer of a device for self-diagnosis for measuring blood sugar that bears a CE marking and that was the subject of a conformity assessment by a notified body to undertake a further assessment in order to certify the conformity of the labelling of that device and the instructions for its use as a result of their translation into the official language of the Member State of importation.
Costs
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.

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

Article 9 of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on
in vitro
diagnostic medical devices must be interpreted as meaning that it does not require a parallel importer of a device for self-diagnosis for measuring blood sugar that bears a CE marking and that was the subject of a conformity assessment by a notified body to undertake a further assessment in order to certify the conformity of the labelling of that device and the instructions for its use as a result of their translation into the official language of the Member State of importation.

[Signatures]
(
*1
)	Language of the case: German.