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Label Content Requirements under MDR regulation

#1
Under MDR, labels will have additional information like name and address of the authorised representative (if the manufacturer is outside the Union), the UDI-DI or the indication that the device is a medical device, etc. This change requires good logistics planning to avoid re-labelling or re-packing. Is it possible to add the additional information required by MDR to the label of a medical device which is still only conform to the MDD? I.e. the label conforms to MDR, but the Declaration of Conformity of the product is in compliance to the MDD. Thanks for your opinion.
 
#2
I see no problem with that as long as there is no direct contradiction between MDR and MDD labelling requirements and that your declaration of conformity is for MDD.
 
#3
Thanks for you reply, shimonv.
I've heard from several experts that if you are in conformity with MDR you are also in conformity with MDD. Therefore in my opinion a label according to MDR can not be in conflict with MDD.
 

Asia78

Starting to get Involved
#4
Hi Lavaux,
We are planning to have the devices developed under MDR requirements, all prepared also the product label. Release will be under mdd and then whenever we have the product code "cleared" we re-release under MDR: the docs to be exchanged will be GSPR, DoC and user Manual. All the rest will stay the same.
 
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