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Document 62015CA0277
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)
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)
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)
IO C 462, 12.12.2016, p. 6–6
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
12.12.2016 |
EN |
Official Journal of the European Union |
C 462/6 |
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
(Case C-277/15) (1)
((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
Bundesgerichtshof
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.