EUDAMED
EUDAMED Registration for IVD Manufacturers
Devices placed on the EU market before 28 May 2026 are to be registered in EUDAMED by 27 November 2026. New devices are registered before they are placed on the market, and registration continues as an ongoing obligation for every product that follows.
I support both situations: the current registration push, and the routine registrations that come afterwards. Once the portfolio grows, manual entry stops being the fastest route and starts being the one most likely to introduce errors.
Why It Takes Longer Than People Expect
Manufacturers who have started usually run into the same handful of things, and none of them is the upload itself.
The Data Is Not Sitting Ready
It exists, but spread across labelling files, ERP, and technical documentation, in different formats and sometimes in different versions. Collecting it, and agreeing which version is the correct one, is the part nobody budgets for.
UDI Has to Match Everything Else
The information has to agree with your technical documentation and your labelling exactly. Mismatches surface late, and correcting them touches more than the database entry.
Legacy Devices Work Differently
They follow different identification rules, using a EUDAMED-DI and EUDAMED-ID rather than a Basic UDI-DI. Easy to get wrong on the first attempt, and tedious to unpick afterwards.
Decisions Nobody Has Made Yet
What goes on the label, how storage and warning information is worded, how product families are grouped. These answers often differ between departments, and EUDAMED forces one version. Every change parked for later has to be either done now or dropped, otherwise the registration you just completed needs updating within weeks.
Manual Entry Gets Risky at Volume
Typing the same fields into a browser a few hundred times is not only slow, it is where transposed digits and copied-down values come from. A mistake in a database record is noticed late and corrected slowly, and correcting it usually touches the documentation behind it too.
Two Routes
Done For You, or Done With You
Done For You
XML Batch Upload
You fill in my detailed Excel template with your product information. I convert it into correctly formatted XML and either handle the upload myself or hand you the file to upload.
- No SaaS subscription, no recurring licence, no hidden costs
- Fast turnaround from completed Excel to finished registration
- Your completed data reviewed before anything is uploaded
- Afterwards you manage your devices in EUDAMED independently
Best for larger portfolios, typically from around twenty UDI-DIs upward, and for anyone working to a deadline. The real threshold depends on your data: how many storage and warning statements each device carries, how consistent the product structure is, and how much of the information is already held in one place.
Price, published
999 EUR setup, up to 5 UDI-DIs
Then 6 EUR per additional UDI-DI. The setup fee covers the Excel template, the consultation while you fill it in, the review of your completed data, the XML build, and the upload. Excl. VAT.
Valid for IVDs under the IVDR and for legacy IVDs. Payment is made in advance, and the registration follows.
Coming back with another batch? Once the setup is done and your data structure is agreed, the consultation part is no longer needed, and the setup fee can be reduced by agreement.
Done With You
Guided Manual Registration
Some manufacturers would rather keep the work in-house, either because the portfolio is small or because they want the knowledge to stay with the team. I walk your people through the manual registration in EUDAMED, screen by screen, and answer the questions as they come up.
- Charged by the hour, no package
- Your team learns the system and keeps the capability
- Useful once, before you register the rest yourselves
- Covers actor registration as well as devices, if that is still open
Best for small portfolios, and teams who will be registering new devices regularly.
Price: 120 EUR per hour, excl. VAT.
Not sure which one fits? For a small portfolio with no deadline pressure, the manual route is usually cheaper. From roughly twenty devices upward, XML normally wins on time, cost, and accuracy, though complex storage and warning information or an inconsistent data structure can move that line in either direction. Send me your device count and a sample of your data, and I will say which one I would pick in your position.
Case Study
34 IVDR Devices Registered in 30 Minutes
A manufacturer with 34 devices certified under the IVDR to register, and no intention of spending weeks on manual entry. Product data was scattered across labelling files and internal systems, in different formats.
The structured template collected every mandatory field in one place. The completed data was reviewed and the open points resolved, then converted to XML and uploaded in a single batch.
Result: 34 devices registered in 30 minutes of upload time. The preparation is where the real work sits, and that is exactly the part that scales, because the same template handles the next batch.
Case Study
382 Legacy IVDs, Still Earning Revenue
Legacy devices certified under the IVDD have to go into EUDAMED as well, and they follow their own identification rules. A portfolio of 382 of them is exactly where the XML route pays for itself.
Entered one by one, that is at least sixteen full working days of a QA or RA specialist doing nothing but typing, with every screen another chance to introduce an error. Prepared as structured data, reviewed once and uploaded in batches, EUDAMED stops being a project and becomes an administrative step. The specialist time goes back to the work that actually needs a regulatory brain.
Medical Devices
The XML service currently covers IVDs. A version for medical devices is in development. If that would be useful for you, tell me and I will let you know when it is ready.