ISO 13485 & EU MDR / Declaration of Conformity according to MDR
Is there a template to follow for the Declaration of Conformity according to MDR?
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No, there is no template in our ISO 13485& MDR Integrated Documentation toolkit. However, guidance on the information that needs to be on the Declaration of conformity can be found in Annex 4 of the MDR.
EU MDR Annex 4 – EU Declaration of conformity https://advisera.com/13485academy/mdr/eu-declaration-of-conformity-2/
thank you so much.
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