Opinion of the Advocate General — ECLI:EU:C:2016:457
Date: 2016-06-16
Language of the case: German
Subject matter: Approximation of laws;Public health
Procedure: Reference for a preliminary ruling
Origin: Germany

Summary — Judgment of the Court (First Chamber), 13 October 2016 1. Approximation of laws — In vitro diagnostic medical devices — Directive 98/79 — Parallel imports — Translation by the importer of the information and instructions for use provided by the manufacturer — Obligation on the importer to undertake a supplementary conformity assessment of those medical devices — None (European Parliament and Council Directive 98/79, Arts 1(2)(f) and 9) 2. Approximation of laws — In vitro diagnostic medical devices — Directive 98/79 — Placing those medical devices on the market — Conformity assessment — Obligation on manufacturers — Concept of ‘manufacturer’ — Parallel importer not putting those devices on the market under his own name — Not included (European Parliament and Council Directive 98/79, Arts 1(2)(f) and 9) 1. Article 9 of Directive 98/79 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. While the Member States are obliged, in the case of a self-diagnosis device, to require the information needed for the safe use of that device 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. (see paras 41, 52, operative part) 2. The obligation to undertake a conformity assessment laid down in Article 9 of Directive 98/79 on in vitro diagnostic medical devices 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, 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. (see paras 43, 44)