High level understanding of EUDAMED

[duff999]

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

 

[twanmul]

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]

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]

INFORMATIONAL: Overview - Public Health - European Commission

EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices.

The new Regulations contain important improvements including a much larger EUDAMED database than the one that currently exists under the Medical Devices Directives (Eudamed2).