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High level understanding of EUDAMED

duff999

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#1
I have been tasked to find more details on EUDAMED. Does anyone have a high level of what is required for suppliers, like us, who supply a product to be used in medical device development, we do not develop the device, but supply a product to be used in its development.

Thanks
 
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twanmul

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#2
It's not really that high level but this user guide created by the EC points you to all the relevant sections of regulations and different actors/economic operators. It might be a bit too much information but should be a good starter. There are also EUDAMED principles documents in the docsroom which again are probably a bit too much information but also a useful resource.
 

duff999

Involved In Discussions
#3
It's not really that high level but this user guide created by the EC points you to all the relevant sections of regulations and different actors/economic operators. It might be a bit too much information but should be a good starter. There are also EUDAMED principles documents in the docsroom which again are probably a bit too much information but also a useful resource.
Thanks for pointing me in the right direction!
 

Marc

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#4
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