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Case C-277/15: Judgment of the Court (First Chamber) of 13 October 2016 (request for a preliminary ruling from the Bundesgerichtshof — Germany) — Servoprax GmbH v Roche Diagnostics Deutschland GmbH (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)
ECLI:EU:UNKNOWN:62015CA0277
62015CA0277
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12.12.2016
Official Journal of the European Union
C 462/6
(Case C-277/15) (<span class="super note-tag">1</span>)
((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))
(2016/C 462/08)
Language of the case: German
Referring court
Parties to the main proceedings
Applicant: Servoprax GmbH
Defendant: Roche Diagnostics Deutschland GmbH
Operative part of the judgment
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.
(<span class="super">1</span>) OJ C 294, 7.9.2015.
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