Informational What's new in ISO 14971:2019

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yodon

Staff member
Super Moderator
#2
Any thoughts / further info on slide 27 points:
  • ...reviewed by the EU HAS consultant for harmonisation... a negative assessment was returned
  • The draft standards harmonisation request prioritises ISO 14971
Is this saying there WILL be a harmonized version (ostensibly to add back the Annex Z items from :2012)?
 

Sam Lazzara

Trusted Information Resource
#3
I took a stab at creating a single flowchart that points out differences between the 2019 standard and the MDR.
This is just a starting point for me. If anyone has any input that I like/agree with (smile) I will surely update it.

Here is a link to my flowchart. This link should work in the future even if I have made updates.
ISO 14971:2019 & Europe MDR Risk Management Process Flow - State of the Art Medical (SAM) Device Intelligence

Here is a link to my prior flowchart focused on EN ISO 14971:2012 versus the Europe MDD.

Note: I created the new chart using LucidChart and would be happy to share the native file if there is any interest. You will probably need a LucidChart account for the files to be useful. I am not affiliated with LucidChart in any way other than being a happy customer.
 
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