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Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. ) article annex_V CELEX: 02017R0746-20250110 CE MARKING OF CONFORMITY
1. The CE marking shall consist of the initials ‘CE’ taking the following form:
2. If the CE marking is reduced or enlarged the proportions given in the above graduated drawing shall be respected. 3. The various components of the CE marking shall have substantially the same vertical dimension, which may not be less than 5 mm. This minimum dimension may be waived for small-scale devices. |