eIFU for medical devices built for the digital era.

Hosting is the easy part. Idntfy takes care of the hard part.

Book a demo See how it works
  • EU MDR, IVDR & FDA
  • EUDAMED import
  • Portal in 31 languages

Paper feels safe. That's exactly the problem.

Every printed copy in the field is a quiet bet that nothing important has changed.

Somewhere right now, a clinician is following instructions you would recall if you could.

With paper, you can't. Not without a field action.

  • A typo becomes a recall

    Relabel, rework, field action, on stock already shipped.

  • Packaging sized by a booklet

    Box size, insertion step, reprint per change, a tax on every unit.

  • Out of your control

    Aggregators republish unasked. Customers find their version, not yours.

  • Paper fails at the worst time

    Gone or unreadable exactly when someone needs the instructions.

Every one of these has the same fix: electronic IFU, done properly.

The recall becomes a five-minute fix.

Same typo. Two completely different days.

On paper
1 Typo spotted in the field
2 Relabel, rework, re-print
3 Field action on shipped stock
! Recall on the record
Weeks, and a recall.The mistake was cheap. Unwinding it was not.
On Idntfy
1 Fix the document
2 Approve, sign-off captured
3 Publish, live in minutes
Subscribers notified automatically
Minutes, and a log entry.Corrected, current, fully traceable.
Minutesfrom correction to live, not weeks
31portal languages, and your documents in any language
7 dayspaper-on-request route, built into the workflow
100%of changes logged: who, what, when

Less chasing. More certainty.

What changes for you and your team, from the first upload to the next audit.

  1. Import your product data from EUDAMED and your existing IFUs in one go. Document details come from your spreadsheet or your own systems, or Idntfy detects them from the files, so your team reviews instead of retyping.

  2. Set the date, the countries and the languages, and Idntfy switches every market over on that day. Where a translation isn't ready yet, readers keep the previous version.

  3. A clinician scans the label and gets the right revision, in their language, for their country. No more questions about which PDF is the current one.

  4. Every upload, approval, publication and download is logged with who and when, and nothing can be changed afterwards. Export it in minutes instead of rebuilding it from inboxes.

See how it works

“It's just a website.” Except… it never is.

Hosting a PDF is the easy 10%. The 90% a regulator cares about sits below the surface.

Above the waterline · the easy 10%

“Just put the PDFs on a page.”

Genuinely easy. Also the only part most plans ever budget for.

Below the waterline · the other 90%
−10m

Security is a job, not a setup

A tampered IFU isn't just a breach, it's a labelling failure.

−45m

Validation never ends

Every change reopens it. Indefinitely, on your time.

−70m

Audit evidence you can't fake at 11pm

Change records, versions, access logs, as a package, not a panic.

−100m

Down during an audit is a non-conformity

Uptime, backup and disaster recovery have to be engineered.

−140m

Year two is what sinks DIY

Patches, upgrades, renewals, pen-tests. Nobody budgets those.

So do the real maths.

“Just a website” quietly bundles development, validation, security, availability and audit. Add every line and the platform isn't the expensive choice, it's the only one with a floor under it. And when the rules shift again, our problem, not yours.

Keep the tools you already use.

Idntfy doesn't replace your QMS, your ERP or your translation agency. Change control stays in your QMS; Idntfy takes over from approval. Product data comes in from EUDAMED or a spreadsheet, and your own systems can push to Idntfy through its API.

Built on the EU rules. Ready for every market.

Idntfy follows Regulation (EU) 2021/2226 line by line. Other markets set their own conditions; because every document is published per country, with that country's languages and dates, the same controls carry over to them.

  1. Art. 5(11)

    The right language in every member state

    Each version carries its countries and languages. A reader in a country gets the language that country requires.

  2. Art. 5(3)

    Paper on request, within seven days

    Paper-copy requests arrive in a queue with their deadline counting down, and every request is logged.

  3. Art. 5(8)

    Readers know when it changed

    Every revision carries its date. Subscribers are told when a new revision goes live.

  4. Art. 5(13)

    Every version, with its date

    Superseded revisions stay on record with the dates they applied, for the full retention period.

  5. Art. 7(2)(e)

    An address that does not move

    Each product has a permanent public address and a QR code for the label, on your own domain if you want one.

  6. Art. 7(2)(b)–(d)

    Protected, available, GDPR-compliant

    Content is protected against tampering, the platform runs across separate data centres, and it is hosted in the EU.

Regulation (EU) 2021/2226

Selling outside the EU as well? The United Kingdom, Switzerland, the United States, Australia and Brazil set their own conditions. Each document is published per country, so every market gets the version and language it requires.

Does my device qualify?

Six questions decide it, and the answer changed in July 2025. If you checked before then and the answer was no, that answer may be out of date.

Open the decision tree

We have built this before.

Built by the team behind a leading eIFU platform, years of onboarding manufacturers big and small.

“Every manufacturer answers to the same regulation. Every one of them deserves documentation that is controlled, current, and provable under audit.”
The Idntfy mission

ISO by design, not bolt-on

Built to 13485 & 27001 from day one. Certification is planned; built in by design beats bolted on under deadline.

We walk the journey with you

Going electronic is a real project. We've run it many times, never a checklist and good luck.

Your data stays yours

Hosted in the EU, in Amazon's Ireland region. Export everything through the API at any time; if you leave, we return your data and delete it.

For the people who ask the harder questions.

Your IT and security colleagues will have a list. Here's what we can answer without a meeting.

More detail on security
Single sign-on
OpenID Connect. Microsoft Entra, Okta and Google. Users are routed to the right identity provider by their email domain.
Roles
A set of standard roles covering the people who actually touch the catalogue. Underneath them sits a permission model of 30 distinct rights, so when custom roles arrive you won't be migrating anything.
Tenant isolation
A separate database schema per customer. Separate, not filtered.
Audit
Every change to every record: who, when, and the previous value.
Custom domains
Your domain, your DNS. Certificates issued and renewed for you.
Hosting
AWS in Ireland. Your data stays in the EU.
Quality system
Built under a quality system aligned to ISO 13485 and IEC 62304, with an ISMS run to ISO 27001. We operate as if certified; certification is planned.

The things people ask us first.

Does eIFU mean no more paper?

Not entirely. A free paper IFU on request, within 7 days, stays, and some devices keep paper where lay-person use is reasonably foreseeable. What changes: the authoritative version lives in one controlled place, and the paper-request workflow runs itself.

Will a Notified Body accept this?

Everything a Notified Body looks for, from security and availability to version control and the website requirements, is what the platform is built to satisfy. We enable compliance; the conformity assessment is still yours to sign.

How hard is the switch, really?

The platform is the easy part; the regulatory change is the real work: risk assessment, supplier qualification, labelling SOPs, training, and a packaging and logistics review wherever paper comes out. We have walked this road many times and walk it with you.

Where is our data hosted?

In the EU, full stop. Encrypted in transit and at rest, GDPR-aligned, built to tick the EU-data-residency procurement checkbox without an asterisk. Need another region? Let's talk.

Who owns the data?

You do, always. We act purely as a processor: never selling, sharing or repurposing your data. Export everything through the API at any time; if you leave, we return your data and delete it on request. No lock-in.

Let's look at your portfolio.

Book 30 minutes. We'll show you the platform, map your portfolio honestly, and tell you straight whether eIFU is your move yet.

Book a demo
  • 30 minutes
  • No slides
  • Honest fit assessment

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