EU MDR Technical Documentation - Defined Review

YellowQCPro

Starting to get Involved
#1
Hello Elsmar!

Can someone point me in the right direction please?

I am looking for any defined requirements that speak to technical documentation maintenance performed by the design holder. I am used to have an internal process that defines the frequency of the review of the technical documentation to ensure it's up to date.
I reviewed EU MDR 2017/745 but could not see where it is required to perform a technical documentation review, define a frequency, gather objective evidence of the review, etc.

Any guidance is appreciated! Thank you!
 
Elsmar Forum Sponsor

Billy Milly

Involved In Discussions
#2
Hi, I don't believe you will be able to define the frequency or interval. Technical documentation should always be up-to-date while needs for updates arise from changed inputs - all standards used for demonstration of conformity, for example. So, if the standard changes, you should update your documents/records proving compliance, if requirements in the standard(s) changed. If nothing changes, no update.
I believe the only explicit part mentioning "TD updates" in MDR is related to PMS requirements.
 
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