e-KT · eIFU · Digital Product Information Platform
Meet TİTCK e-KT (1 Jan 2027) and
MDR/IVDR eIFU (EUDAMED mandatory since 28 May 2026)
obligations from a single platform.
The deadline is approaching
Setup takes 1 day, first QR code in 10 minutes.
Get StartedeKT.one — TİTCK + MDR/IVDR compliant digital product information management platform. Enables pharmaceutical companies to deliver e-KT via QR code, and medical device manufacturers to publish eIFU via GS1 Digital Link with full EUDAMED compliance management. Same rules in Turkey and the EU — one platform.
A patient scanning the QR code on packaging reaches the current instructions within seconds. No paper printing required.
Every update is archived with date, approver, and full content. Full traceability is instantly available for TİTCK audits.
Content in Turkish, English, Arabic, and every active language in the system. No extra steps needed for foreign-national patients.
Full accessibility for visually impaired patients with AI/studio-quality text-to-speech. WCAG 2.1 AA compliant.
Upload a TİTCK-approved PDF; AI automatically produces a TİTCK IRD-KLVZ-07 compliant 5-section HTML e-KT. No manual copying or formatting.
Visualise QR scan data on a Turkey province map and world map. Breakdown by city, language, and action — who is scanning which product?
Display product-specific or company-wide OTC ads in the right column of the leaflet page. PNG, GIF, and HTML banner support.
Company users manage all their leaflets, subscription status, and remaining quotas on a single screen.
Patients can ask the AI questions while reading the leaflet; answers are based solely on that product's leaflet content. Pharmacovigilance signals are reported automatically.
Scan the GS1 DataMatrix on the device; the /01/<GTIN> path resolves directly to the eIFU page. Lot and serial number variants are all handled by one resolver — no extra QR code needed.
Generate the eIFU URL for your UDI-DI record with a single click. EUDAMED compliance checklist, ÜTS sync status, and paper copy request channel are managed on one screen.
All published eIFU versions with dates and full content are kept in a publicly accessible archive. MDR/IVDR Article 7 compliance is automatic; the EUDAMED deep link is exportable with one click.
eKT.one is indicated for the following situations:
Full compliance with the e-KT obligation mandatory from 1 January 2027 (TRANSITIONAL ARTICLE 3).
Reflecting every change to the TİTCK-approved text in the digital environment within the legal timeframe, with deadline tracking.
Content, version, and QR code management for 25 to unlimited products from a single panel; multi-company support.
Turkish Tebliğ 22.04.2026 (OJ 33232) is fully aligned with EU 2021/2226 + 2025/1234. One platform, two jurisdictions. MDR/IVDR eIFU obligations for medical device manufacturers and importers are met in full.
Upload a TİTCK-approved PDF; AI reads the text and produces a TİTCK IRD-KLVZ-07 (Rev.17) compliant 5-section HTML e-KT in minutes. Studio narration can be added with a single click.
Every QR scan is recorded by province, country, language, and action. A Turkey choropleth map and world map show which city and language it was read in. The company dashboard is GDPR-compatible and contains no personal data.
Display product or company OTC banners (PNG/GIF/HTML) in the right column. Company users independently track subscription status and quota usage via the /my/prospectus portal.
EUDAMED's first 4 modules have been mandatory since 28 May 2026. The eIFU internet address is a required field in the UDI-DI record. The platform generates the eIFU URL, manages the EUDAMED compliance check, and tracks ÜTS sync status.
The device barcode resolves to the eIFU via the /01/<GTIN>/10/<lot>/21/<serial> syntax. The UDI search page (/udi-search/) enables product discoverability from GTIN, Basic UDI-DI, or UDI-DI.
eKT.one should not be used in the following situations:
After 1 January 2027, packaging with only a printed leaflet will violate TİTCK regulations.
A visual-only (JPG/PNG) or non-updatable static file link does not meet the TİTCK standard.
Steps to get started:
Your company registers on the platform. Choose S / M / L / E package based on product count.
The TİTCK-approved leaflet is uploaded as HTML or PDF. The Responsible Manager publishes it with a digital declaration.
A unique QR code is generated for each drug. The mandatory TİTCK text (Scan the code for information media.) is added automatically.
When a QR code is scanned, the patient reaches the current leaflet. Access data is reported in a GDPR-compatible manner.
Pricing is based on a per-leaflet unit price. As your portfolio grows, the system automatically upgrades your tier — unit price decreases, earned features are retained.
Every package can be extended with optional features. Add-ons are also billed on a per-leaflet unit price basis.
An AI chat button for patients and pharmacists to ask natural-language questions, with answers based solely on the leaflet content.
Have the AI interpret dashboard analytics with a single click; receive manager-specific action recommendations.
Natural studio-quality voice instead of standard TTS. Pauses in headings, slower tempo for warnings.
ERP integration, custom reporting, or bespoke module development.
Results reported by our users, listed by frequency:
All e-KT requirements are met. The 30-day update deadline is tracked automatically; alerts are sent to the responsible user.
No location, contact, or personal data is collected when a QR code is scanned. IP addresses are stored as one-way SHA-256 hashes.
Screen reader support, audio instructions, keyboard navigation. Full accessibility for visually impaired patients.
The QR code on the medicine box works any time, anywhere. System downtime is a drug safety risk — we know that.
eIFU can be provided for all professional-use devices; if lay use is intended, the paper IFU request channel is managed by the platform. Turkish Tebliğ 22.04.2026 (OJ 33232) is fully aligned with EU 2025/1234.
All published eIFU versions with dates are archived and publicly accessible. The eIFU URL for the EUDAMED UDI-DI record is exportable with a single click.
eKT.one is not a closed box. Your analytics and signal data can be exported into your own systems today.
GET /api/v1/analytics — export your view, language and geography data into your own BI tool.
GET /api/v1/signals — feed pharmacovigilance, stockout and patient adherence signals into your CRM or data warehouse.
Live, public API documentation at ekt.one/api/docs — no need to request a demo, explore it directly.
Access via an X-API-Key generated from your own user profile — no separate integration account required.
curl -H "X-API-Key: <your-key>" \
"https://ekt.one/api/v1/analytics?limit=10"