BDA current fee schedule, reviewed for 2026, in EUR.
8 fee lines100% exact amountscurrency EURFX rates 2026-08-26reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Class I device registration (single device) | EUR 255.65 | $298 | Per device | Verified |
| Class I device registration (group of devices) Rises with the number of devices in the group up to EUR 1,227.10. | EUR 281.21–1,227.10 | $328–$1,432 | Per group | Verified |
| Custom-made device registration (single device) Groups: EUR 102.26 up to EUR 766.94. | EUR 25.56 | $29.83 | Per device | Verified |
| IVD List A/B registration (single device) Applies to immunological and molecular-biology IVDs; other IVDs: EUR 51.13 single, groups EUR 255.65–1,124.84. | EUR 204.52 | $239 | Per device | Verified |
| Change to a registered Class I device IVD changes: EUR 102.26. | EUR 127.82 | $149 | Per change | Verified |
| Clinical-investigation permit assessment Change to a permit: EUR 76.69. | EUR 1,533.88 | $1,790 | Per application | Verified |
| Wholesale-activity certificate Change: EUR 76.69. | EUR 1,533.88 | $1,790 | Per certificate | Verified |
| Wholesale permit (import/export/distribution) Change: EUR 127.82. | EUR 2,556.46 | $2,983 | Per permit | Verified |
- Amounts follow the BDA tariff effective 1 January 2026.
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Exact amounts verified against the BDA fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:bulgaria:class-i-registration