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EUDAMED MDR / IVDR Excel Template
The MDR / IVDR Excel template supports you in compiling and managing all MDR / IVDR Eudamed device data required by the European Commission.
If required, the template enables you to create convenient solution variants in combination with other products and services from our portfolio.
EUDAMED data must be prepared and collated for upload to the European Commission’s EUDAMED database.
The easiest way is to enter all information in a template with several tabs.
- Template for collecting Basic UDI-DI and UDI-DI attributes
- Template for collecting additional information such as packaging, market information and much more
- Highlighting of mandatory fields
- Easy input with the help of drop-down menus
- Designed for easy data transfer to EUDAMED
- Descriptions in German and English
Q: Will there be an annual fee for updates?
A: No. €295 is a one-time fee.
Q: Will this table help us with our EUDAMED uploads?
A: Yes, but not 100%. You still need to convert the data to XML. We have designed the table to make this process much easier. The tabs in the table more or less correspond to what is needed for EUDAMED.
Q: Is it possible to convert XLSX to XML using the template?
A: At the moment this conversion is a separate service. The XML conversion is kept outside the spreadsheet because of its complexity.
Q: How do I get the most out of the Excel template?
A: That depends on your general conditions. In any case, it makes sense to check whether you can make use of another service from our portfolio. You could choose a transfer service where we would take over the transfer of the data to the database for you. Furthermore, the template in combination with our UDI EUDAMED Sap Add-On offers many other advantages.
Q: Can you say something about the degree of “validation”, or how were the fields restricted and how are dependencies evident?
A: We have not restricted any fields. We highlight the mandatory fields and the dependent applicable fields.
Q: Do you expect updates?
A: Updates yes, this will happen, but only for the enumerations or value lists provided by the European Commission. Some of them have not yet been published, e.g. critical warnings.
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