Hi,
This discussion i am starting with my earlier post in the Forum "Question on EU MDR745/2017 - Annex I Section: 23.2 Information on the label "
As per the MDR Label definition " 'label' means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices."
The question on the above definition is that we have medical devices with various classification( Class IIa, Class III) and we are facing difficulties in finding space to add the new MDR labelling contents like Clinical benifits, Performance characteristics, Intended patient population etc. Which doesnt involve symbols. How to solve the space crisis?
Usually we used to have the IFU information printed in case carton and mostly avoid IFU leaflets. the constraint is we need to translate those informations into 14 different languages and it leads to sapce crisis then leads to creating a IFU insert (Pamplet) that will incur lot of cost to the company.
If we could able to provide a weblink or 2D barcode in the IFU (information encrypted) and that will minimize the requirement of additional space.Please let me know will it be accepted by notified bodies or is there any other way address these types of contents for which symbol will not be answer.
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Vadivelan Dharanisingh
Product Regulatoy Lead
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