Forms, fees & timelines
Fee schedules and timelines change. Always verify current figures at gov.uk and with your chosen UKAB before making regulatory plans.
MHRA fees
| Fee type | Where to find current amount |
|---|---|
| Device registration fee | gov.uk/guidance/register-as-a-manufacturer-to-sell-medical-devices |
| Annual registration fee | Same as above — fees are published annually |
| Pre-submission meeting fee | gov.uk/guidance/pre-submission-meetings-for-medical-devices |
| Export certificate fee | gov.uk/guidance/apply-for-a-certificate-of-free-sale |
SME discounts apply — check the guidance for eligibility criteria.
Key process timelines (indicative)
| Process | Indicative timeline |
|---|---|
| MHRA device registration (straightforward) | 2–4 weeks after complete submission |
| Pre-submission meeting with MHRA | 4–12 weeks from request to meeting |
| UKAB initial certification — Class IIa (QMS) | 3–9 months from application |
| UKAB initial certification — Class III (QMS + design dossier) | 6–18 months from application |
| MHRA export certificate | 2–4 weeks |
UKAB timelines vary significantly based on device complexity, technical file completeness, UKAB capacity, and workload. Always request indicative timelines and expected milestones from your chosen UKAB at first contact, and allow additional time for clarification requests or technical queries.
Key forms
| Form / Process | Where to access |
|---|---|
| Device registration | MHRA Submissions portal: submissions.mhra.gov.uk |
| Vigilance report | MHRA Submissions portal |
| FSCA notification | MHRA Submissions portal |
| Export certificate application | MHRA Submissions portal |
| Pre-submission meeting request | gov.uk/guidance/pre-submission-meetings-for-medical-devices |
| Clinical investigation notification | MHRA Submissions portal |
Official references
| Reference | Description |
|---|---|
| MHRA: Register as a manufacturer | Registration fees and guidance |
| MHRA Submissions portal | All forms and submissions |
SME fee reductions: MHRA offers fee reductions for micro, small and medium-sized enterprises (SMEs) on device registration and some pre-submission services. Eligibility is based on employee headcount and turnover thresholds. Verify current eligibility criteria and discount percentages on gov.uk.