Where to find MDR compliance device?

[itscloud]

Hello

Does anyone know if such database exists? Please kindly share : )

Thanks and Regards

 

[itscloud]

I read this on the PR Newswire: "As published on the EU MDR website, VenusP-ValveTM is noteworthily the first Class III implantable cardiovascular device approved under the new MDR. Coming into effect in May 2021, the new regulations set out stricter and more specific standards in technical review and clinical evaluation and require the establishment of expert panels to support such evaluations. After the new rules were adopted, there was no CE MDR certificate issued to any Class III implantable cardiovascular device until VenusP-ValveTM, which is stark evidence of Venus Medtech's world-class clinical trial and quality control systems. "

I'm curious about this "EU MDR website", seems like there is a database listing MDR compliant devices? Does anyone know where to access this databse?

 

[Ronen E]

EUDAMED

 

[itscloud]

EUDAMED

Many thanks for the link Ronen!

 

[itscloud]

I think the database is not fully usable, there are limited information, I can only find few device/certificate information even I enlarge the search criteria

 

[Raisin picker]

The EUDAMED (pronounced U-damn-it) modules for device registration are fully functional, but not yet mandatory (for several years, IIRC). Afaik, there's only one other database: Google ;-) The first devices under MDR received some media coverage, and that's where that VenusP-Valve is mentioned.
An if you check here (CECP opinions), it might be one of the devices mentioned (they are anonymised).

 

[itscloud]

The EUDAMED (pronounced U-damn-it) modules for device registration are fully functional, but not yet mandatory (for several years, IIRC). Afaik, there's only one other database: Google ;-) The first devices under MDR received some media coverage, and that's where that VenusP-Valve is mentioned.
An if you check here (CECP opinions), it might be one of the devices mentioned (they are anonymised).

Wow, great info source on this page, never knew that, thank you!