The early-access programs
France's Forfait Innovation: coverage-with-evidence-development for breakthrough devices — the 2026 SAPIEN M3 proof point.
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The early-access programs, the innovation doors, and the payers' logic — with the EU practice you need.
Sourced from verified 2026 publications.
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What's inside
Every figure in this guide traces to a named source — verified 2026 publications.
France's Forfait Innovation: coverage-with-evidence-development for breakthrough devices — the 2026 SAPIEN M3 proof point.
Germany's NUB, France's LATM and PECAN, the UK's triple gate: CE/UKCA, DTAC, and NICE.
CE marking authorises placement, not payment — national HTA decisions and the parallel-discipline logic of market access.
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.
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A Market Access Strategy Session maps your reimbursement route — HTA positioning, innovation-door strategy, and payer evidence.
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