MDR GSPR Checklist template

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monoj mon

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#2
(Just in case if no one shares any template here) Actually it is not difficult to create your own checklist. Just go through the online resources and see what they are talking about the checklist. For example, you can look into this and this.
 

Kuldeep Singh

Involved In Discussions
#5
Hello,

We are Manufacturer of CT Scan machine . During an audit, auditor ask for justification for non applicability of directives other than EU 2017/745 such as PPE directive and so on (as listed in Classification summary table of document as attached in #3).
Is there any directive applicable to us other than EU MDR 2017/745.

Can anyone please provide me a sufficient justification for directives not applicable to us, so that we can add these in our technical documentation.
 
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