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EU Device Reimbursement2026 Field Guide

The early-access programs, the innovation doors, and the payers' logic — with the EU practice you need.

Core rule
CE≠paid
Forfait Inn.
2015
Germany
NUB

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 early-access programs

France's Forfait Innovation: coverage-with-evidence-development for breakthrough devices — the 2026 SAPIEN M3 proof point.

The innovation doors

Germany's NUB, France's LATM and PECAN, the UK's triple gate: CE/UKCA, DTAC, and NICE.

The payers' logic

CE marking authorises placement, not payment — national HTA decisions and the parallel-discipline logic of market access.

Sources & scope

  • mtrconsult.com, Forfait Innovation favorable opinion (SAPIEN M3, Sep 2026).
  • mtrconsult.com, The application period for the 2026 NUB innovation funding is open in Germany.
  • iclg.com, Evolution of Digital Health Reimbursement (US, Germany, UK, France).

This guide is market-access intelligence, not regulatory, reimbursement, or legal advice. EU reimbursement programs, HTA criteria, and payer rules change — professional review is required before business use.

Market Access Strategy Session

EU reimbursement on your 2026 roadmap? Start with the full picture.

A Market Access Strategy Session maps your reimbursement route — HTA positioning, innovation-door strategy, and payer evidence.

Professional review is required before business use.