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Art. 14 Affixing conformity markings and identification numbers
1 The conformity marking and, where necessary, the associated identification number shall be affixed to the device itself or its sterile packaging. 2 Where this is not possible or practicable owing to the nature of the device, the conformity marking and, where necessary, the associated identification number must be displayed on the packaging. 3 The conformity marking shall also appear in the instructions for use and on the sales packaging. 4 The requirements of Article 20 paragraphs 3–6 EU-MDR35 and the general principles of Article 30 Regulation (EC) No. 765/200836 must also be observed when affixing the conformity marking. 35 See the footnote to Art. 4 para. 1 let. f. 36 Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93, last amended by OJ L 218 of 13.8.2008, p. 30. |