MDR 2017/745 · IVDR 2017/746 · EU 2021/2226 · 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.
- 1eIFU QR — GS1 Digital Link; scan it, the IFU for that lot opens
- 2UDI DataMatrix — UDI-DI + UDI-PI (GS1 element string)
- 3Permanent eIFU address registered in EUDAMED
- EUMDR 2017/745
- EUIVDR 2017/746
- EU2021/2226 + 2025/1234
- EUEUDAMED
- TRÜTS
- GS1Digital Link
- ISO15223-1:2021 + Amd 1:2025
- W3CWCAG 2.1 AA
- EU · TRGDPR · KVKK
- 28.05.2026 New devices: EUDAMED registration before placing on the market
- 28.11.2026 EUDAMED registration of devices already on the market (legacy) 15 days left
- EUDAMED + ÜTS
- two registries, one checklist
- /01/{GTIN}
- GS1 Digital Link resolver
- 24/7
- free access, no registration
- TR · EN
- label statement ready
Research — eIFU Readiness Index 2026
Only 17% of Turkish manufacturers' device models on the market have an eIFU link in EUDAMED.
The EU-27 average is 25%. The report is built from public EUDAMED data and names no company. It is itself an eIFU: always current, can be listened to and answers questions.
- 0.1% of device models on the market in Türkiye have an EUDAMED link that opens the device's own instructions. 17% of models have an eIFU link in EUDAMED; of those links, 99% go to the manufacturer's shared page rather than the device (EU-27: 82%).
- 43% Share of models registered or updated since 28 May. EU-27: 61%. Devices already on the market must be registered by 28 November 2026. 15 days left
- 10.7% eIFU link rate in new MDR/IVDR models. All 1,508 models registered after 28 May were scanned.
Source: public EUDAMED data (European Commission), 13 October 2026. Rates refer to the eIFU link field in EUDAMED; an empty field does not necessarily mean the device has no eIFU. Edition 3.
00 — Before November 2026
Six 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.
Does the URL in EUDAMED actually open your eIFU page?
The Registration Centre compares each device's EUDAMED eIFU URL with its eIFU.one address every week and states what to do for any mismatch.
Will you enter hundreds of URLs one by one?
From the XML you download from EUDAMED, a schema-valid file is prepared that updates only the eIFU URL; you upload it through EUDAMED Bulk Upload.
01 — Resolution
2D code to IFU in four steps, zero apps.
-
01
Scan
The eIFU QR on the label
GS1 Digital Link -
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 | Registration Centre (EUDAMED) | Weekly check of the eIFU URL in EUDAMED with a 28 November countdown; schema-valid bulk update file that changes only the eIFU URL; 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 | EUDAMED URL check and bulk update; ÜTS checklist |
| 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 IFU address must stay stable and directly accessible; a login or form keeps users away from the IFU.
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 Basic UDI-DI
The unit price drops as your portfolio grows. Quotes are based on Basic 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
- Your own subdomain (e.g. eifu.yourbrand.com)
- API integration
- SLA and account manager
07 — Symbols
Explanation of symbols
Symbols used on the label — ISO 15223-1:2021 (incl. Amd 1:2025) and ISO 7000 standard graphics.
- ManufacturerLegal manufacturer; name and address next to it.
- Authorized representative in the EURequired for non-EU manufacturers. Amd 1:2025 replaces "EC REP" with "EU REP".
- Date of manufactureDate the device was made.
- Use-by dateDo not use after this date.
- Catalogue numberManufacturer's product reference.
- Batch codeThe /10/ qualifier in the eIFU address.
- Unique device identifierUDI carrier and human-readable UDI line.
- Medical deviceIndicates the product is a medical device.
- Sterilized using ethylene oxideSterile state and method.
- Do not re-useSingle-use device.
- Do not use if package is damagedThe sterile barrier may be compromised.
- Keep dryProtect from moisture.
- Keep away from sunlightStore away from direct light.
- CautionConsult the IFU for warnings and precautions.
- Consult instructions for useThe address next to it (eIFU indicator) shows the IFU is provided electronically.
- CE markingWith the notified body number for Class IIb (XXXX in this sample).
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. A manufacturer using eIFU provides the eIFU address in the UDI-DI record. The address must stay stable, all previous versions must remain available with their publication dates, and a paper copy must be supplied free of charge within 7 days on request.
Is the UDI DataMatrix enough, or do I need a QR code?
The UDI DataMatrix on your label carries a GS1 element string; a phone camera does not open it as a web address. Add a QR code carrying the GS1 Digital Link (https://…/01/{GTIN}/10/{lot}) — eifu.one resolves it straight to the eIFU page of that lot. The same address is what you register in EUDAMED.
How do we know the eIFU URL in EUDAMED is correct?
The eIFU.one Registration Centre compares the eIFU URL in each device's EUDAMED record with its eIFU.one address every week: matching, different address, address missing or device not registered. For each issue it states the next step; the days left to 28 November 2026 are shown on the dashboard. If EUDAMED cannot be read, the result is "could not verify" — never "matching".
How do we enter eIFU URLs for many devices in EUDAMED?
You do not have to enter them one by one. Download your devices as XML from EUDAMED; eIFU.one prepares a file, valid against the EUDAMED schema, that updates only the eIFU URL. You upload it through EUDAMED Bulk Upload — no access point or machine-to-machine connection is needed, and all other device data stays as it is. eIFU.one does not upload to EUDAMED on your behalf.
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 — one QR on your label is enough.