Regulatory Open Forum

Hello everyone,

Our company, based in the US, is already registered in EUDAMED as a single operator manufacturer and has a SRN. We have a legacy device and UDI-DI for each model issued by GS1.

We want to register our medical devices in EUDAMED but can not locate this. Can we do this or is this an Authorized Representative or Notified Body activity?

Thanks.

Hello everyone,

Our company, based in the US, is already registered in EUDAMED as a single operator manufacturer and has a SRN. We have a legacy device and UDI-DI for each model issued by GS1.

We want to register our medical devices in EUDAMED but can not locate this. Can we do this or is this an Authorized Representative or Notified Body activity?

Thanks.

Hi Anon,

Good on you for being proactive and wanting to enter your UDI information on Eudamed! The UDI/Device Registration module just open last week. This is something that manufacturers have to do themselves (not the EAR or NB).

If you don't have a lot of UDI/devices to enter, the Eudamed web form is the easiest method. If you have a lot of records to enter, then you may want to consider the bulk XML method. Here's a quick overview with the web form method:

1. REQUEST "CONFIRMER" ACCESS TO THE UDI/DEVICE MODULE

By default each Eudamed user has "Viewer" access only to the UDI/Device module so you need to request "Confirmer" access first. 

a) Before you start, make sure you have at least two users in Eudamed because another LAA/LUA will need to approve your profile update request. 

b) Go to: https://webgate.ec.europa.eu/eudamed/landing-page#/, click on the "Enter with EU login" button.

c) Once logged in, click on your Name (top right corner).

d) Scroll down to "Account data" and click on "Request for change".

e) Confirm your information at Step 1 "My user manager". Click "Save & Next".

f) At Step 2, under UDI/Device, select "Confirmer" (by default "Proposer" will also be selected). You can put an end date if desired. Then click "Submit".

g) Ask another LAA/LUA to log in and accept your request. They should also receive your request via an automatic email. Once logged in, they will find your request under "Tasks" > "User management" > "Assess user access requests". It should show a red notification.

2. REGISTER YOUR UDI(s)/DEVICE(s)

Once your request has been accepted by one of your LAAs/LUAs, log in again (step 1.b) and go to "UDI-DIs/Device" under "Tasks":

Click on "Register a legacy device" and then follow the web form instructions and you should get there.

Then you can then go back to the "Home" tab, under "Tasks" and manage your UDI/Device information from there.

I hope this is helpful! 

Hello everyone,

Our company, based in the US, is already registered in EUDAMED as a single operator manufacturer and has a SRN. We have a legacy device and UDI-DI for each model issued by GS1.

We want to register our medical devices in EUDAMED but can not locate this. Can we do this or is this an Authorized Representative or Notified Body activity?

Thanks.

Hi Anon,

Good on you for being proactive and wanting to enter your UDI information on Eudamed! The UDI/Device Registration module just open last week. This is something that manufacturers have to do themselves (not the EAR or NB).

If you don't have a lot of UDI/devices to enter, the Eudamed web form is the easiest method. If you have a lot of records to enter, then you may want to consider the bulk XML method. Here's a quick overview with the web form method:

1. REQUEST "CONFIRMER" ACCESS TO THE UDI/DEVICE MODULE

By default each Eudamed user has "Viewer" access only to the UDI/Device module so you need to request "Confirmer" access first. 

a) Before you start, make sure you have at least two users in Eudamed because another LAA/LUA will need to approve your profile update request. 

b) Go to: https://webgate.ec.europa.eu/eudamed/landing-page#/, click on the "Enter with EU login" button.

c) Once logged in, click on your Name (top right corner).

d) Scroll down to "Account data" and click on "Request for change".

e) Confirm your information at Step 1 "My user manager". Click "Save & Next".

f) At Step 2, under UDI/Device, select "Confirmer" (by default "Proposer" will also be selected). You can put an end date if desired. Then click "Submit".

g) Ask another LAA/LUA to log in and accept your request. They should also receive your request via an automatic email. Once logged in, they will find your request under "Tasks" > "User management" > "Assess user access requests". It should show a red notification.

2. REGISTER YOUR UDI(s)/DEVICE(s)

Once your request has been accepted by one of your LAAs/LUAs, log in again (step 1.b) and go to "UDI-DIs/Device" under "Tasks":

Click on "Register a legacy device" and then follow the web form instructions and you should get there.

Then you can then go back to the "Home" tab, under "Tasks" and manage your UDI/Device information from there.

I hope this is helpful! 

Hello everyone,

Our company, based in the US, is already registered in EUDAMED as a single operator manufacturer and has a SRN. We have a legacy device and UDI-DI for each model issued by GS1.

We want to register our medical devices in EUDAMED but can not locate this. Can we do this or is this an Authorized Representative or Notified Body activity?

Thanks.

Hi Anon,

Good on you for being proactive and wanting to enter your UDI information on Eudamed! The UDI/Device Registration module just open last week. This is something that manufacturers have to do themselves (not the EAR or NB).

If you don't have a lot of UDI/devices to enter, the Eudamed web form is the easiest method. If you have a lot of records to enter, then you may want to consider the bulk XML method. Here's a quick overview with the web form method:

1. REQUEST "CONFIRMER" ACCESS TO THE UDI/DEVICE MODULE

By default each Eudamed user has "Viewer" access only to the UDI/Device module so you need to request "Confirmer" access first. 

a) Before you start, make sure you have at least two users in Eudamed because another LAA/LUA will need to approve your profile update request. 

b) Go to: https://webgate.ec.europa.eu/eudamed/landing-page#/, click on the "Enter with EU login" button.

c) Once logged in, click on your Name (top right corner).

d) Scroll down to "Account data" and click on "Request for change".

e) Confirm your information at Step 1 "My user manager". Click "Save & Next".

f) At Step 2, under UDI/Device, select "Confirmer" (by default "Proposer" will also be selected). You can put an end date if desired. Then click "Submit".

g) Ask another LAA/LUA to log in and accept your request. They should also receive your request via an automatic email. Once logged in, they will find your request under "Tasks" > "User management" > "Assess user access requests". It should show a red notification.

2. REGISTER YOUR UDI(s)/DEVICE(s)

Once your request has been accepted by one of your LAAs/LUAs, log in again (step 1.b) and go to "UDI-DIs/Device" under "Tasks":

Click on "Register a legacy device" and then follow the web form instructions and you should get there.

Then you can then go back to the "Home" tab, under "Tasks" and manage your UDI/Device information from there.

I hope this is helpful! 

Hello everyone,

Our company, based in the US, is already registered in EUDAMED as a single operator manufacturer and has a SRN. We have a legacy device and UDI-DI for each model issued by GS1.

We want to register our medical devices in EUDAMED but can not locate this. Can we do this or is this an Authorized Representative or Notified Body activity?

Thanks.

Hello everyone,

Our company, based in the US, is already registered in EUDAMED as a single operator manufacturer and has a SRN. We have a legacy device and UDI-DI for each model issued by GS1.

We want to register our medical devices in EUDAMED but can not locate this. Can we do this or is this an Authorized Representative or Notified Body activity?

Thanks.