HPRA current fee schedule, reviewed for 2026, in EUR.
15 fee lines100% exact amountscurrency EURFX rates 2026-10-11reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Manufacturer establishment registration (code 431) Not charged where registration is effected directly through EUDAMED. | EUR 150 | $168 | Per registration | Verified |
| Annual manufacturer fee by employee count (codes 458–462, 470) Tiers: EUR 33,430 / 22,285 / 16,715 / 5,570 / 1,395 / 275. | EUR 275–33,430 | $308–$37,459 | Per year | Verified |
| Annual authorised-representative fee - Type I Capped at EUR 6,000. | EUR 1,200 | $1,345 | Per year | Verified |
| Annual authorised-representative fee - Type II Capped at EUR 8,175. | EUR 1,635 | $1,832 | Per year | Verified |
| Annual distributor/importer fee by employee count Tiers: EUR 5,015 / 2,790 / 1,395 / 275; dual distributor-importer roles over 3 million pay an additional EUR 1,090. | EUR 275–5,015 | $308–$5,619 | Per year | Verified |
| Clinical-investigation application Class III/IIb: EUR 4,700; Class IIa/I: EUR 2,075. | EUR 2,075–4,700 | $2,325–$5,266 | Per application | Verified |
| Clinical-investigation notification (Art. 74-type) | EUR 220 | $247 | Per notification | Verified |
| IVD performance-study application | EUR 2,725 | $3,053 | Per application | Verified |
| Substantial modification of an investigation/study | EUR 1,360 | $1,524 | Per modification | Verified |
| Resubmission of an investigation/study application Academic-sponsored resubmissions: EUR 560. | EUR 2,075 | $2,325 | Per resubmission | Verified |
| Free-sale certificate Covers up to four products; each additional product EUR 25. | EUR 280 | $314 | Per certificate | Verified |
| Registration status letter | EUR 130 | $146 | Per letter | Verified |
| Digital certificates (certified copies) | EUR 200 | $224 | Per certificate | Verified |
| Assessment of an MDR Art. 59 exemption request | EUR 4,370 | $4,897 | Per assessment | Verified |
| Classification determination EUR 335 / 1,210 / 10,760 / 655 by determination type. | EUR 335–10,760 | $375–$12,057 | Per determination | Verified |
Government fees only — service and testing costs are separate- Notified-body designation fees (EUR 11,145 / 5,570 plus EUR 1,995 per assessor day) are charged to the bodies; total annual fees per organisation are capped at EUR 66,860.
- HPRA fee codes referenced (431, 458–462, 470) come from the published account structure.
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Exact amounts verified against the HPRA fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:ireland:manufacturer-registration