Legacy device EUDAMED registration

[itscloud]

Hi all,

I'm confused with the registration of legacy device in EUDAMED.

The UDI-DI code which I entered below is model/specification specific. However, the generated EUDAMED DI seems to be model/specification specific as well.

But the EUDAMED DI is supposed to act as a role of Basic UDI-DI right?

So, shall I just fill our company product's Basic UDI-DI in the UDI-DI code in this case? But it does not work if I added the check number(Alphabets)

What should I do?

Thanks

 

[Junn1992]

EUDAMED DI

The Eudamed ID and DI are meant for devices which do not already have a UDI-DI or BUDI issued by the 4 agenices

 

[itscloud]

The Eudamed ID and DI are meant for devices which do not already have a UDI-DI or BUDI issued by the 4 agenices

Then how do you explain this?

 

[Junn1992]

hmm with your check characters it is 15 characters long. Found this in the user guide:

 

[itscloud]

The generated EUDAMED DI code seems like a UDI-DI to me instead of Basic UDI-DI which MDCG 2019-5 indicates: "a Eudamed DI will be assigned to the device instead of the Basic UDI-DI".

The below highlighted UDI-DI code is only just one specification of our device, we have many other specifications.

Does this mean that for every specifications we will have a different EUDAMED DI (Instead of Basic UDI-DI)?

However, isnt it EUDAMED DI is similar to Basic UDI-DI under MDR which is unique?

 

[Junn1992]

Ok this is where things can get confusing, but upon careful reading we can find the answers.

I refer to MDCG 2019-5:

"For this purpose, a Eudamed DI will be assigned to the device instead of the Basic UDI-DI and a Eudamed ID will be assigned by Eudamed instead of the UDI-DI"

Eudamed DI = Basic UDI-DI ( what you have shown above )

Eudamed ID = UDI-DI (which refers to a specific device model)

So after you got the Eudamed DI, you now need the Eudamed ID.

Please refer to user guide section 4 https://ec.europa.eu/health/documen...name=md_eudamed_udi-devices-user-guide_en.pdf

 

[itscloud]

Seems like you will have a Eudamed DI & Eudamed ID for every single specification of the legacy device. That is a lot of work

 

[Junn1992]

Wow ok never knew that, thanks for sharing!