Swedish Medical Products Agency current fee schedule, reviewed for 2026, in SEK.
9 fee lines100% exact amountscurrency SEKFX rates 2026-08-26reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Annual fee per registered role - manufacturers and authorised representatives Covers CE products, custom-made devices and NMI; also due when registration takes place in EUDAMED (dataset absent for Sweden). | SEK 30,000 | $3,166 | Per role, per year | Verified |
| Legacy/directive-product company registration Per förordning (1993:876). | SEK 2,150 | $227 | Per year | Verified |
| Legacy/directive-product registration by product count Up to 10 products SEK 1,000; up to 100 SEK 2,000; up to 500 SEK 5,000; over 500 SEK 10,000. | SEK 1,000–10,000 | $106–$1,055 | Per year | Verified |
| Exemption from conformity assessment (MDR Art. 59 / IVDR Art. 54) Payable regardless of outcome since 1 January 2022; no fee for language-requirement exemption applications. | SEK 62,000 | $6,543 | Per application | Verified |
| Export certificate (MDR Art. 60 / IVDR Art. 55) Each subsequent identical copy: SEK 600. | SEK 1,300 | $137 | Per certificate | Verified |
| Extended export certificate Each copy: SEK 800. | SEK 2,300 | $243 | Per certificate | Verified |
| Clinical investigation / performance study - single-state procedure SEK 60,000 (Art. 70.7(b)); SEK 25,000 (Art. 70.7(a)); SEK 16,000 (Art. 74.1 notification); SEK 11,000 (Swedish föreskrift application); SEK 13,000 (substantial modification). | SEK 11,000–60,000 | $1,161–$6,332 | Per application | Verified |
| Clinical investigation - multi-state procedure (MDR Art. 78) SEK 65,000 when Sweden coordinates; otherwise SEK 60,000; substantial modification SEK 13,000. | SEK 60,000–65,000 | $6,332–$6,860 | Per application | Verified |
| Notified-body annual fee Base fee plus SEK 7,550 per code and SEK 450 per manufacturer. | SEK 750,000 | $79,155 | Per year | Verified |
Government fees only — service and testing costs are separate- Fees follow förordning (2021:988) om avgifter i ärenden om medicintekniska produkter as published by Läkemedelsverket.
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Exact amounts verified against the Swedish Medical Products Agency fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:sweden:annual-manufacturer-ar-fee