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Declaration of Conformity according to MDR
Is there a template to follow for the Declaration of Conformity according to MDR?
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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Kristina Zvonar Brkić
May 18, 2021
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/
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