Information on product and packaging labels
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Yes, I agree that product label does not contain only UDI information. However, there is no requirement both in ISO 13485:2016 and in MDR 2017/745 to have a procedure for labelling.
Information that need to be on the label and Instruction of use are descibed in MDR 2017/745 in General safety and perfromence requirements, Annex I – in Chapter III REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE. - https://advisera.com/13485academy/mdr/general-requirements
In Article 7 Claims you can see information how clains for intended use are supposed to be stated. https://advisera.com/13485academy/mdr/claims/
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Jul 29, 2020