Overview
Before you send a device spreadsheet through the free readiness check or a paid Data Prep Sprint, it helps to know what the importer is actually looking for. That comes down to two questions: which fields are mandatory for your legislation, and does your spreadsheet already use a column header the importer recognizes.
This page answers both, generated from the same field registry the pipeline itself reads, not a separately maintained description of it, which is how a guide like this quietly falls out of sync with the product.
What we need from you
28 of the 67 EUDAMED fields EUDAMate maps are mandatory for MDR, but most of those aren't things you need to go find. Below, 14of them are data only you have. The rest, EUDAMate generates, sets automatically, classifies, or infers on its own, showing you anything it couldn't settle for a quick check instead.
Basic UDI-DI data
Shared by every variant of the same device model: risk class, device name, applicable legislation.
UDI-DI data
Specific to this exact device version: EMDN code, catalogue number, sterility, quantity.
What EUDAMate handles for you
These 14 fields are also mandatory for MDR, but nothing here requires you to add a column. Some may still come back to you as a quick check on anything it couldn't settle on its own.
Taken from the legislation you select above, not looked up per device.
Matched from your device's description during the paid Data Prep Sprint review, not the free upload above, if you don't already have a code. For about seven in ten devices the right code is on screen when you open that review; for the rest, one line about the product finds it; and every code you confirm teaches the system for your next upload.
Filled from your device's description or from EUDAMED's own published data, wherever that can be done safely. Measured against 878 real EUDAMED registrations across 11 of these yes/no questions: it answers 87 out of every 100 of them on its own, and 99 out of every 100 of those answers match what the manufacturer had declared. The rest it leaves blank with a note explaining why, instead of guessing. One more shown here for this legislation is inferred the same way but hasn't been through that benchmark yet.
Frequently Asked Questions
Do I need to rename my spreadsheet's columns to match EUDAMED's exact field names?
Usually not. The importer matches a large set of common header variations, including abbreviations, legacy terminology, and translated headers, to the correct field automatically. Search for your own column header in the reference below; if it appears, upload the file as-is.
What file formats can I upload?
CSV, XLSX, XLS, and TSV. Anything else is rejected before processing starts.
Does one spreadsheet row need to correspond to one device?
Yes. The importer treats every data row as a single device record. EUDAMED itself processes bulk submissions per device rather than as one all-or-nothing batch, so a spreadsheet organized the same way maps cleanly.
Which row does the importer treat as the column header row?
The first row of the sheet. There is currently no option to point the free readiness check at a different row or a specific tab in a multi-sheet workbook, so put your headers on row one of the sheet you want checked.
What happens to my file after I upload it?
It is deleted from the server once your report has been generated, whether the run succeeds or fails, and none of its contents are retained: not the rows, and not the filename. The only things we keep about you are your email address and company name, and only if you give them to us, alongside the figures the report itself produced such as the device count and score.
Are the same fields mandatory for legacy devices under MDD, AIMDD, or IVDD?
The two-part Basic UDI-DI / UDI-DI structure carries over, but legacy devices use EUDAMED DI and EUDAMED ID terminology in place of Basic UDI-DI and UDI-DI, and the mandatory set is narrower than under MDR or IVDR. Select MDD, AIMDD, or IVDD in the reference below to see how each set differs. Only one field in the legacy set actually carries a distinct legacy label, so most rows will not show one.