EN

Official Journal of the European Union

C 118/4

(Case C-662/15)

(2016/C 118/05)

Language of the case: German

Referring court

Parties to the main proceedings

Applicant and appellant: Lohmann & Rauscher International GmbH & Co. KG

Defendant and respondent: BIOS Naturprodukte GmbH

Question referred

Are Article 1(2)(f), Article 11, point 13 of Annex I and the last indent of point 3 of Annex VII [to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices] (1) to be interpreted as meaning that a further conformity assessment procedure is required for the marketing of a Class I medical device, which has been made subject to a conformity assessment procedure by the manufacturer and lawfully bears the CE marking affixed by the manufacturer, where the information relating to the central pharmaceutical number (Pharmazentralnummer) on the outer packaging of the medical device has been concealed by a sticker which provides the importer’s details and the central pharmaceutical number granted to that importer, the other information remaining visible?

(1) OJ 1993 L 169, p. 1.