Hi Anonymous,
1. Firstly yes the bulk upload is available in EUDAMED. Go to the Transmission menu, select Upload, and then on the right of the form, there is a button New Upload. On the next screen, you select the XML file and you must select the correct service you are uploading to.
2. I would not advise using both XML and web forms. The EC made a change at the last minute, just before go-live which means you must specify, in the XML, the last version of the specific entity, Basic UDI, UDI DI, etc. This means if you manually create a version via the web application then in your XML creator you need some way of adding the version number otherwise when you decide to upload a new version of the manually created device you will not have the correct version number in your XML and your upload will be rejected.
This new requirement has added complexity not only for you but also for our software packages (EudaMed SaaS and EudaMed+). Currently, we have to manage the batches so no duplicates are uploaded but now we also have to trace all versions of all devices for both the playground and production, which brings a new level of complexity.
You sound like you are creating your own software for XML validation and management, this is a large time and financial investment, if you have not started I would recommend you check with companies like ours because you will not only save financially but you will also offload a major headache.
I hope this helps.
Best regards, Richard Houlihan | 
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EirMed Ltd |
Brussels, Belgium | Sofia, Bulgaria |
t: +359 2 492 8458 |
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e: richard.houlihan@eudamed.com |
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EudaMed.com | |
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