MDR · IVDR · EUDAMED · GS1 Digital Link
The IFU isn't in the box.
It's in the 2D code.
Publish the electronic instructions for use of your medical devices; manage the permanent address for EUDAMED and ÜTS, the version archive and paper-copy requests in one place.
- 28.05.2026 New devices: EUDAMED registration before placing on the market
- 28.11.2026 EUDAMED registration of devices already on the market (legacy) 60 days left
- 1GS1 Digital Link DataMatrix — scan it, the eIFU opens
- 2Lot/serial qualifier opens the right version
- 3Permanent eIFU address registered in EUDAMED
- EUDAMED + ÜTS
- two registries, one checklist
- /01/{GTIN}
- GS1 Digital Link resolver
- 24/7
- free access, no registration
- TR · EN
- label statement ready
00 — Before November 2026
Four eIFU checks before you register in EUDAMED.
The eIFU address is part of the UDI-DI record, and EUDAMED data must be consistent with labelling and IFU. Inconsistent links surface exactly when your data is reviewed.
Does every marketed device have a stable, correct eIFU link?
The link is tied to the GTIN and does not change when content changes; the lot qualifier opens the right version.
Do your eIFU addresses map to your device list?
Each UDI-DI maps to one access point; the Basic UDI-DI → UDI-DI hierarchy lives on the device record.
Will the link survive the device lifecycle?
The availability end date is derived from the expected lifetime; earlier versions stay in the public archive.
Do registration and IFU teams work from the same source?
EUDAMED and ÜTS checklist, address and IFU sit on the same device record, with role-based approval and audit trail.
01 — Resolution
2D code to IFU in four steps, zero apps.
-
01
Scan
The GS1 DataMatrix on the label
GS1 Digital Link URI -
02
Resolve
GS1 Digital Link resolver
/01/{GTIN}/10/{lot} -
03
Open
The device's current eIFU page
language · version · PDF -
04
Archive
Older version for older devices
/01/{GTIN}/versions
02 — Intended purpose
Which obligations does it meet?
MDR/IVDR eIFU compliance
EU 2021/2226 (as amended by 2025/1234) and the Turkish communiqué of 22.04.2026 (OJ 33232) are fully aligned. One content set, two markets.
EUDAMED and ÜTS registration
The permanent eIFU address for the UDI-DI record comes from the platform; registration status is tracked with a checklist.
Availability over the device lifetime
The availability end date is derived from the expected lifetime; you are warned before it ends.
Paper-copy requests
Define the channel for paper IFU requests; the label statement comes ready in Turkish and English.
03 — Components
Parts list
| Item | Component | Function |
|---|---|---|
| 01 | GS1 / UDI resolver | Lot and serial variants under one address; public search by GTIN, Basic UDI-DI or UDI-DI. |
| 02 | EUDAMED compliance assistant | eIFU URL in one click; checklist for EUDAMED and ÜTS, paper-channel test and label statement. |
| 03 | Version archive | Every publication kept with its date, publicly; compare any two versions side by side. |
| 04 | Risk assessment record | Reference and date of the assessment behind the eIFU decision, on the device record. |
| 05 | PDF → eIFU page | AI drafts a readable, accessible HTML page from the approved IFU PDF; publishing needs human approval. |
| 06 | Multilingual content | Languages per market; AI translation drafts with per-language approval. Unapproved translations never go live. |
| 07 | User assistant | Healthcare professionals ask while reading; answers draw only on that device's IFU. |
| 08 | Read-aloud | A narrated version of the IFU on a WCAG 2.1 AA page structure. |
| 09 | Scan analytics | Which device's IFU is opened, in which country and language — no personal data collected. |
04 — Regulation
EU and Turkey: same rules, two registries.
| European Union | Turkey | eIFU.one | |
|---|---|---|---|
| eIFU rules | 2021/2226 + 2025/1234 | Communiqué 22.04.2026 · OJ 33232 | One content set, two markets |
| Framework | MDR 2017/745 · IVDR 2017/746 | Aligned TİTCK legislation | Regime and class on the device record |
| Registry | EUDAMED | ÜTS | Checklist for both registries |
| eIFU address | Field of the UDI-DI record | In the ÜTS record | Permanent address in one click |
| Identifier | UDI-DI · Basic UDI-DI | GTIN / UDI | GS1 Digital Link resolver |
- GS1 Digital LinkLot, serial and expiry qualifiers supported.
- GDPR / KVKKNo personal data from readers; IP stored only as a one-way hash.
- WCAG 2.1 AAScreen reader, keyboard navigation and read-aloud.
- 24/7 accessPublic page with no registration, account or fee.
05 — Warnings
These do not meet the eIFU obligation
No version history; the address changes with the next redesign and the EUDAMED link breaks.
Users of devices already on the market must reach the IFU for their device.
The eIFU must be accessible free of charge, without registration, 24/7.
Procedure
-
1
Define the device
Basic UDI-DI, UDI-DIs, class, intended user, markets.
-
2
Upload the IFU
PDF or HTML; approval per language, then publish.
-
3
Register the address
Enter the eIFU address in EUDAMED and ÜTS; add the label statement.
-
4
Keep it current
Each revision is a new version; the old one is archived, the address stays.
06 — Packages
Unit price per device (UDI-DI)
The unit price drops as your portfolio grows. Quotes are based on UDI-DI count, markets and languages.
Starter
Small portfolio
- GS1 Digital Link resolver
- EUDAMED eIFU URL
- Public version archive
- Paper-copy request channel
- Email support
Growth
Multi-product manufacturer
- Everything in Starter
- PDF → AI page drafting
- AI translation + per-language approval
- Scan analytics
- Priority support
Enterprise
Large portfolio / group
- Everything in Growth
- User assistant and read-aloud
- Custom domain
- API integration
- SLA and account manager
07 — Symbols
Explanation of symbols
- ManufacturerLegal manufacturer of the device.
- Date of manufactureDate the device was made.
- Catalogue numberManufacturer's product reference.
- Batch codeThe /10/ qualifier in the eIFU address.
- Unique device identifierThe UDI in the GS1 DataMatrix.
- Medical deviceIndicates the product is a medical device.
- Consult electronic instructions for useShows that the IFU is provided electronically, and where.
- CautionA warning or precaution to observe.
08 — FAQ
Frequently asked questions
What is an eIFU?
An eIFU (electronic Instructions for Use) is the digital form of the paper Instructions for Use of a medical device. Under EU Regulation 2021/2226 (amended by 2025/1234) and the aligned Turkish communiqué of 22.04.2026 (OJ 33232), manufacturers may provide the IFU electronically instead of on paper.
Is the eIFU address required in EUDAMED?
EUDAMED's first four modules, including UDI/Device registration, have been mandatory since 28 May 2026 (Commission Decision (EU) 2025/2371): new devices must be registered before being placed on the market, and devices already on the market (legacy devices) by 28 November 2026. The eIFU address is part of the UDI-DI record and must be freely accessible, without registration, 24/7.
Do I need a separate QR code for the eIFU?
No. eifu.one resolves the GS1 DataMatrix already on your label via GS1 Digital Link (/01/{GTIN}/10/{lot}/21/{serial}) directly to the eIFU page.
What happens to older IFU versions?
Every published version is kept with its date in a public archive, so users of devices already on the market can still reach the version that applies to them.
Get your first eIFU address live today.
From device definition to publication in a day — the 2D code on your label is enough.