# C_2015294EN.01002801.xml

| 7.9.2015 | EN | Official Journal of the European Union | C 294/28 |
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7.9.2015

EN

Official Journal of the European Union

C 294/28

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Request for a preliminary ruling from the Bundesgerichtshof (Germany) lodged on 9 June 2015 — Servoprax GmbH v Roche Diagnostics Deutschland GmbH

(Case C-277/15)

(2015/C 294/34)

Language of the case: German

Referring court

Referring court

Bundesgerichtshof

Parties to the main proceedings

Parties to the main proceedings

Appellant on a point of law: Servoprax GmbH

Appellant on a point of law:

Respondent in the appeal on a point of law: Roche Diagnostics Deutschland GmbH

Respondent in the appeal on a point of law:

Questions referred

Questions referred

| 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 (1) 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 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? |
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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 (1) 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 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?

in vitro

1

| 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? |
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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?

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(1)  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), as amended by Commission Directive 2011/100/EU of 20 December 2011 (OJ 2011 L 341, p. 50).

1

in vitro

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