Guide

EUDAMED and the eIFU address: what manufacturers must provide and when

Reviewed 7 October 2026 · Sources: EUR-Lex, European Commission · By Scan & Care · Not legal advice

The short answer

Where registration in the UDI/Device module of EUDAMED is mandatory, manufacturers who provide instructions for use in electronic form must give the internet address where the eIFU can be accessed (Regulation (EU) 2025/1234). The first four EUDAMED modules have been mandatory since 28 May 2026. The address is a long-term commitment: choose one that does not change.

Which EUDAMED modules are mandatory, and since when?

EUDAMED is the European database on medical devices. Commission Decision (EU) 2025/2371, published on 27 November 2025, declared the first four modules functional: actor registration, UDI/Device registration, notified bodies and certificates, and market surveillance. Under the transitional rules of Regulation (EU) 2024/1860, each module becomes mandatory six months after the notice is published, so these four modules became mandatory on 28 May 2026.

The dates that matter

DateWhat happens
16 July 2025Regulation (EU) 2025/1234 enters into force: eIFU is allowed for all medical devices intended for professional users.
27 November 2025Decision (EU) 2025/2371 is published: the first four EUDAMED modules are declared functional.
28 May 2026The four modules become mandatory, including UDI/Device registration.

The dates follow the Commission's published timeline. Check the official notice, and your own devices' situation, with your regulatory adviser.

What must you provide about the eIFU?

  • The internet address where the electronic instructions for use can be accessed, entered when you register the device in the UDI/Device module, where registration is mandatory.
  • An address that leads to the instructions of that device, on a website that meets the requirements: a format readable with free software, protection against unauthorised access, data protection and the history of issued versions.
  • Availability. The address must work when people need it, and your risk assessment must cover the case in which the website is unavailable.
  • Consistency with the label. The device or its packaging must tell users that the instructions are electronic and how to access them.

What makes a good eIFU address?

The regulations ask you to provide an address; they do not say what it should look like. These are practical recommendations.

  • Permanent. The address should not change when you update the document: it should always show the current version, with the version history behind it.
  • Clean. No session identifiers or tracking parameters that can expire or break the link for someone else.
  • Open. Reachable without a login, from any country and any device, over HTTPS.
  • Consistent. Decide whether you use one address per device or per product family, and document the rule.
  • Monitored. Check the addresses regularly and assign someone to fix broken ones.
  • Multilingual. Give users an easy way to choose the language; the language requirements of each Member State still apply.

Checklist

  • List the devices that use eIFU and confirm that each one is intended exclusively for professional users.
  • Decide the address pattern (one per device or per product family).
  • Publish the eIFU and its version history at the final addresses before you register.
  • Test each address in a private window, on a phone and from another country.
  • Enter the address when you register the device in the UDI/Device module.
  • Ask your regulatory adviser whether a transitional deadline applies to devices already on the market.
  • Set up monitoring and a procedure for updating the registered information if an address ever has to change.

Where Scan & Care fits

Scan & Care publishes each product's documents on a public page reachable through a QR code, with versioning and multilingual documents, and paid plans allow a custom domain. It supports the operational side and does not replace the manufacturer's regulatory assessment. Ask any provider, including us, how it guarantees that an address stays valid.

Start free for 12 months Calculate your paper cost

Frequently asked questions

Do I need an eIFU address for every device?

The obligation concerns devices whose instructions are provided in electronic form. For devices that keep paper instructions only, there is no eIFU address to provide. Check the data required for your devices with your regulatory adviser.

Is the eIFU address the same as the QR code?

No. The address is the information registered in EUDAMED; the QR code is a way for users to reach it from the label. Often the QR code points to the same address, but they are separate things.

What happens if the address changes?

The registered information has to be revisited for every affected device. A permanent address avoids that work.

Since when is EUDAMED registration mandatory?

The first four modules, including UDI/Device registration, have been mandatory since 28 May 2026, under the transitional rules of Regulation (EU) 2024/1860. Check with your regulatory adviser whether a transitional deadline applies to devices already on the market.

Where can I find the official information on EUDAMED?

On the European Commission's EUDAMED pages and in Regulation (EU) 2024/1860 and Decision (EU) 2025/2371. The links are listed under Sources.

Sources

This page is a plain-language summary for information only. It is not legal advice. Dates follow the Commission's published timeline and may be updated. Always refer to the official texts and to your regulatory affairs adviser or notified body before registering your devices or changing how your instructions for use are provided.

G-TY5DWPMMJP