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Declaration of Conformity according to MDR

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Guest user Created:   May 17, 2021 Last commented:   May 19, 2021

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.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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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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daisy ann Pacaro Ceriales May 19, 2021

thank you so much.

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May 17, 2021

May 19, 2021