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Checklist for Clinical Investigation compliant to EU-MDR

#1
Hi all, I have been asked to go through the clinical investigation plans of a number of clinical trials concerning a class IIb and a class III med device, not yet in the market, not yet CE marked. The goal is to check that their design and available plans are MDR compliant.
Anybody has any ideas how to proceed with the MDR compliance part given that the investigators have requested for a checklist? I was thinking about preparing an excel file and go through articles 61-80 but any smart idea (or suggestions for available checklists) from the community will be appreciated.
Thks!
 
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SKM.Sunil

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#3
Please go through this attachment .....may help you.

and consider ISO 14155 for clinical trials out side EU. [cause MDR is a law in EU, that may not be acceptable in other countries, so in that case comply with ISO 14155 and local trial/study regulations.

All the Best.
 

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Sullen-gent

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#5
I have a similar challenge and wondered if anyone knew whether we should be reviewing 14155 2019 rather than the requirements of 2011 for MDR compliance?

Am I right in thinking that the 14155 2019 version will be the MDR Harmonised standard?
 
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