AEMPS current fee schedule, reviewed for 2026, in EUR.
10 fee lines100% exact amountscurrency EURFX rates 2026-08-26reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Registration/communication of medical devices (code 5.01) Transfer of communications to the new Registro de comercialización (RECOPS) is exempt per RD 192/2023 DT séptima. | EUR 99.71 | $116 | Per communication | Verified |
| Prior operating licence - manufacturing, sterilisation, reprocessing establishments (code 5.17) | EUR 983.85 | $1,148 | Per licence | Verified |
| Manufacturing-licence modification/revalidation (code 5.19) | EUR 983.85 | $1,148 | Per modification | Verified |
| Prior operating licence - import and grouping establishments (code 5.18) | EUR 491.92 | $574 | Per licence | Verified |
| Import-licence modification/revalidation (code 5.20) | EUR 491.92 | $574 | Per modification | Verified |
| Minor modification of licences (code 5.21) | EUR 245.96 | $287 | Per modification | Verified |
| Authorisation of clinical investigations / IVD evaluation studies (code 5.22) Fee proof must accompany the application; the fee lapses 10 working days after payment. | EUR 1,553.51 | $1,813 | Per application | Verified |
| Substantial modification of a clinical investigation (code 5.23) | EUR 543.73 | $635 | Per modification | Verified |
| Classification/qualification analysis consultation (code 5.26) | EUR 211.61 | $247 | Per consultation | Verified |
| Authorisation of import of human-origin raw materials for IVD manufacture (code 5.24) | EUR 87.40 | $102 | Per authorisation | Verified |
Government fees only — service and testing costs are separate- Amounts follow the published AEMPS fee table (tabla de tasas, tipo 5) as updated on the official site.
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Exact amounts verified against the AEMPS fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:spain:registration-communication