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European Union medical device government fees

Partially verified

EMA / national competent authorities official fee source and current amount-availability status.

7 fee lines86% exact amountscurrency EURFX rates 2026-09-07reviewed 2026-08-25
Fee lineOfficial amountUSD equivalentFrequencyProvenance
EMA consultation - ancillary medicinal substance not previously evaluatedEUR 114,700$133,206Per consultationVerified
EMA consultation - ancillary medicinal substance previously evaluatedEUR 57,200$66,429Per consultationVerified
EMA consultation - change to an ancillary medicinal substanceEUR 5,000$5,807Per consultationVerified
EMA consultation - absorbed or locally dispersed substance-based deviceEUR 86,100$99,992Per consultationVerified
EMA consultation - companion diagnosticEUR 56,500$65,616Per consultationVerified
EMA consultation - change affecting a companion diagnosticEUR 5,000$5,807Per consultationVerified
Member-state competent-authority and actor-registration fees
No EU-level government fee exists for device conformity assessment, certification, or registration: Art. 111(1) MDR and Art. 104(1) IVDR allow only Member States to levy fees, transparently and on cost-recovery principles. Notified-body fees are commercial and each body must publish its standard fee list (Art. 50 MDR).
Varies by member state—By authority and procedureOfficial source
Government fees only — service and testing costs are separate
  • There is no single EU government fee for ordinary CE marking. National competent-authority fees vary by member state and procedure.
  • The exact amounts shown are statutory EMA consultation fees for the specific device routes named in each row; Regulation (EU) 2024/568 applies from 1 January 2025.
  • Eligible EMA-recognized small and medium-sized enterprises receive a 90% reduction on these device-consultation fees, and eligible microenterprises receive a 100% reduction.
  • Notified-body conformity-assessment charges are commercial fees and are intentionally excluded from the government-fee rows; the Commission maintains a separate list of their published fee schedules.
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Pending exact primary-source verification · last internal update 2026-08-25 · row IDs are stable — cite as government-fees:eu:ema-ancillary-substance-new