2021年11月2日 · I cannot post links yet but I can show you the way. Enter to your Eudamed module and go to Help/User guide. Then, click to "EUDAMED Information Centre". Once inside go to "Bulk uploading-downloading" option. As you see they are downloading options but no uploading. It is presumable they will be soon according to the title of this section.

2021年10月11日 · Response from MedTech: No based on MDCG 2019-5, upon occurrence of an Incident or a Corrective Action, registration is required upon registration of the Incident or Corrective Action in EUDAMED 6 months after the notice in …

2023年1月27日 · Received information from the Eudamed help desk. In case anyone else has the same issue, you need to login to your account, select 'Manage your actor data', select 'Create new version', select 'yes' to confirm, scroll down to modify the PRRC name or select 'Add a new regulatory person', then save and confirm your update.

2022年10月21日 · Eudamed is free, you can register your products UDI by yourself; But to register in your EU Rep country, it normally cost , like is Netherlands 200 euro. Your EU Rep may charge 300 or 500 Euro. I think in future, may no need …

2021年5月24日 · Hello, I own a company in Germany and one of my business partner wants us as European Authorized Representative for a product, a mask. I tried to create an account on webgate.ec.europa.eu/cas/login (EUDAMED restricted). After I input my name and e-mail and clicked on the create account button...

2021年11月2日 · No I ended up uploading them individually, there was no free template, like MHRA. The Eudamed template was at a cost of around £400. Couldn't justify that cost, so ended up doing it individually. I used the MHRA templates …

2021年12月22日 · Hi there, I've faced some difficulties in registering my UDIs in EUDAMED (first I did not have the buttons “register”, and second I was not able to grant access to another user) and finally I've realized that this was because I totally misunderstood the functions of the LAA and LUA profiles...in case someone has the same problems, the ...

2025年3月2日 · It is OK, i have made about 520 devices. It taked me about one week. So, keep going and be strong. There is no easy way (or free way). I tried to find easy and fast way to upload all devices to EUDAMED and it takes almost same time, and found nothing. So, if you start manualy today, you will have it sooner.

2022年5月17日 · 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.

2019年10月24日 · How do we get a “Single Registration Number”? I understand this number is provided by an electronic system that should be set up by the European Commission, as per Article 30. So, is this electronic system EUDAMED? However, I just tried to play around MDR-EUDAMED I do not have an SRN yet. I...