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Free field guide · PDF

Medical Device Labeling2026 Field Guide

The code, the pixels, and the practice — with the labeling work you need.

Carriers
AIDC+HRI
EUDAMED
May 2026
Digital
eIFU

Sourced from verified 2026 publications.

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What's inside

Five pages, zero fluff

Every figure in this guide traces to a named source — verified 2026 publications.

The code

The code: UDI carriers at every packaging level — AIDC + HRI, DataMatrix for implants and Class III.

The pixels

The pixels: eIFU under EU 2021/2226, FDA electronic labeling, and the digital direction of travel.

The practice

The practice: EUDAMED deadlines, sterile-barrier labeling, and the QMS-controlled label process.

Sources & scope

  • informait.com, UDI Labeling Requirements: What Medical Device Manufacturers Need on Every Label.
  • alephuniversity.us, Medical Device Labeling: UDI & IFU Guide.
  • getgen.ai, 6 key EU medical device labeling requirements.

This guide is market-access intelligence, not regulatory or legal advice. Labeling requirements, UDI rules, and eIFU practice change — professional review is required before business use.

Market Access Strategy Session

Labeling on your 2026 roadmap? Start with the full picture.

A Market Access Strategy Session maps your labeling route — UDI carrier design, eIFU strategy, and EUDAMED registration.

Professional review is required before business use.