Parallel importer of certified self-diagnosis device not obliged to confirm conformity of translation label in importing Member State
13-10-2016 Print this page
Parallel importer of a self-diagnosis device is not obliged to carry out a new assessment in the importing Member State to certify the conformity of the labelling and the translation of the instructions for its use, when that device has already been subject to a conformity assessment by a notified body and it bears a CE marking.
" 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."
IPPT20161013, CJEU, Servoprax v Roche Diagnostics
C-277/15 - ECLI:EU:C:2016:770
