Free · No payment required

EUDAMED Readiness Check

Upload your device spreadsheet. We check it against 19 EUDAMED validation rules, covering up to 88 field-level checks, and show you exactly what's missing, miscoded, or will be rejected on submission.

19 MDR/IVDR/MDD validation rules, up to 88 field-level checks

EMDN classifiability scored per device

Column mapping gaps identified instantly

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.

Accepted files

.csv, .xlsx, .xls, .tsv

Size limit

10 MB

Rows

1 row = 1 device

Header row

The first row of your sheet

After upload

File deleted once your report is generated

NOTE

Your spreadsheet is deleted from our server once the report is 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 those we store the figures the report itself produced, such as how many devices the file held and what it scored.

Legislation