Hello,
I would like to get an expert's opinion regarding the registration of our subcontractors in Eudamed.
If we follow the instructions in the guide, we are required to register the names of our Chinese suppliers, even though we are the legal manufacturer.
I contacted Eudamed support, and here is their response:
"If you have a subcontractor manufacturing the devices, please include their information in the device registration. This does not change the fact that you are the legal manufacturer."
My current issue is that for a single product reference, we may have several suppliers.
My question is, how do you handle this situation? Do you list the names of all the suppliers in Eudamed?
Thank you for your feedback.
Christelle L.
Hi Christelle, 1) can you give me a printscreen where you have provided the details of the supplier?
and 2): which guidance do you refer to?
Dear Christelle,
This is a requirement of the regulation, you have to register all subcontractors contributing to the device’s manufacture.
You should list each subcontractor separately within EUDAMED, specifying their specific role as "packaging”, assembly of the components" etc..
You can also copy paste what you have written in your technical documentation : refer to MDR - Annex II §3, (c) identification of all sites, including suppliers and sub-contractors, where design and manufacturing activities are performed.
I hope it is clearer.
Dear @elem-ayne,
Thanks for your message .
Yes, that's understood. However, Eudamed does not allow you to enter multiple subcontractors: only one manufacturer can be registered in this section. This is precisely the problem ☹️
I see. Please write directly to EUDAMED to know how you can register all the subcontractors. If it is not possible, in this case, you can register the main subcontractor. Here is the contact : SANTE-EUDAMED-SUPPORT@ec.europa.eu or https://webgate.ec.europa.eu/udi-helpdesk/en/welcome-to-eu-udi-helpdesk.html