EU MDR & IVDR — Medical Device UDI

Who it affects

Medical device and IVD manufacturers placing products on the EU market, including importers, distributors, and authorized representatives.

What it requires

EUDAMED (including the UDI/Device registration module) becomes mandatory from May 28, 2026. New devices must be registered in EUDAMED before first unit reaches market. Legacy devices already on market must be registered by November 28, 2026. Device packaging must carry a QR code or URL linking to the eIFU registered in EUDAMED.

How QRStandard helps

Host eIFU links behind QR codes on device packaging. Update the destination as documents are revised — without reprinting labels. Audit trail documents every URL change for MDR/IVDR compliance records and notified body review.

What you get

The infrastructure behind every compliant QR code

PrintOnce Redirect

Print once. Update forever.

The QR code is affixed to the product at the factory. The URL behind it is managed from your dashboard. Your documentation server changes — the code on the product does not.

Document Hosting

Upload your document. No server needed.

Attach a PDF manual, safety datasheet, or certificate directly to the QR code. No external hosting required — your document is stored in the EU and served instantly on scan.

Audit Trail

Every change logged for inspection.

Every destination change is recorded: timestamp, previous URL, new URL, and the user who made it. Export as CSV for regulatory inspection documentation in seconds. Immutable by design.

Bulk Generation

Thousands of codes. One CSV upload.

Upload serial numbers and destination URLs. Download a ZIP of print-ready QR codes. No per-scan fees — ever. No infrastructure to maintain on your side.

Start your EU MDR / IVDR registry today.

Start your Registry — first 3 codes free. No credit card required. EU-hosted, GDPR compliant by design.

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First 3 dynamic codes free · No scan caps · No code expiry

EU MDR / IVDR