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Free access Generate your EUDAMED XML files free of charge and validate them on your EUDAMED test environment (playground) before any production submission. Terms of use

A price list, not a quote

The price is public, and it depends on one thing: your volume.

Every tier gives access to the same modules and the same checks. No feature is reserved for a higher tier: only the volume of UDI-DI prepared per year changes. A manufacturer with forty references should not pay for a thousand-reference catalogue's infrastructure.

Access to the platform is free as of today. The prices below are published in advance and will apply from a date we will announce: they let you plan with full information, they are not billed today.

Let's EUDAMED platform pricing

Included in every tier, at no extra cost

  • Every module: MDR, systems and procedure packs, IVDR, legacy devices, targeted updates, vigilance and retrieval requests.
  • The entire library of checks, published and named. No rule is reserved for a higher tier. Checks
  • The return path: an EUDAMED XML response becomes a readable Excel workbook again.
  • The conformity report, every issue citing its rule, row and field.
  • The interface and templates in French, English, Spanish and Italian.
  • Your organisation's accounts, with no per-user billing.

Assisted deployment

Migration of your existing data, mapping to the templates and start-up. This one-off service is not in the grid: its cost depends on the actual state of your data, which we look at before quoting. A quote given without seeing the files would be a made-up number.

Request a scoping call

What about fully on-premise use?

The desktop application runs on an isolated workstation, with no network and no account. Its licence is counted in workstations and duration, not in UDI-DI: it therefore falls outside this grid and is quoted separately.

Desktop application

What to know before choosing

  • All amounts are excluding tax, in euros, for twelve months.
  • Volume counts distinct UDI-DI prepared during the year, not files uploaded or analyses re-run: fixing and re-running a file consumes nothing extra.
  • Reaching a tier's cap mid-year blocks nothing: we warn you beforehand, and moving up is prorated over the remaining term.
  • There is no self-service sign-up: every access follows a reviewed request. A tier is chosen after that conversation, never before.

Let's EUDAMED

What this price does not buy

Not submission on your behalf — we do not connect to EUDAMED —, not a guarantee that a file will be accepted, and not regulatory advice. You are buying the preparation and checking of your data, and the ability to cite the rule behind every issue. Nothing more, and we will never imply otherwise.

Excel → XML

Describe your catalogue and we will tell you which tier fits it.

Volume, device families, state of your existing data: those three things are enough to place your need, and the conversation commits you to nothing.

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