MHRA official fee source and current amount-availability status.
12 fee lines100% exact amountscurrency GBPFX rates 2026-11-09reviewed 2026-10-21
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Medical Device Registration Statutory Fee Level 2, or Level 1 where no Level 2 exists; fee year 1 April 2026 to 31 March 2027. After MHRA recalculation, outstanding annual fees for devices placed on the market are due 6 November 2026; unpaid accounts are suspended thereafter. This is not a per-product or ordinary variation fee. | £300 | $401 | Per chargeable GMDN category, annual (pro rata for registration during the fee year) | Verified |
| Clinical Investigation - Initial/Other Chargeable Submission (Class I, IIa, or IIb other than implantable or long-term invasive) Group A under reg52; reg56(1) distinguishes qualifying resubmissions from other chargeable notices. Current table also covers device studies in Northern Ireland. This MD clinical-investigation tariff is not an IVD performance-study or ordinary manufacturer/brand/REF variation charge. | £15,309 | $20,457 | Per initial or other chargeable notification | Verified |
| Clinical Investigation - Initial/Other Chargeable Submission (Class IIb implantable or long-term invasive, III, or active implantable) Group B under reg52; reg56(1) distinguishes qualifying resubmissions from other chargeable notices. Current table also covers device studies in Northern Ireland. This MD clinical-investigation tariff is not an IVD performance-study or ordinary manufacturer/brand/REF variation charge. | £32,016 | $42,781 | Per initial or other chargeable notification | Verified |
| Clinical Investigation - Qualifying Resubmission (Class I, IIa, or IIb other than implantable or long-term invasive) Group A under reg52; reg56(1) distinguishes qualifying resubmissions from other chargeable notices. Current table also covers device studies in Northern Ireland. This MD clinical-investigation tariff is not an IVD performance-study or ordinary manufacturer/brand/REF variation charge. | £11,701 | $15,635 | Per qualifying resubmission limited to addressing refusal/withdrawal grounds | Verified |
| Clinical Investigation - Qualifying Resubmission (Class IIb implantable or long-term invasive, III, or active implantable) Group B under reg52; reg56(1) distinguishes qualifying resubmissions from other chargeable notices. Current table also covers device studies in Northern Ireland. This MD clinical-investigation tariff is not an IVD performance-study or ordinary manufacturer/brand/REF variation charge. | £22,678 | $30,303 | Per qualifying resubmission limited to addressing refusal/withdrawal grounds | Verified |
| Certificate of Free Sale £75 per order for the first 10 certificates; each additional certificate on the same order £10. Eligible UK manufacturer/UKRP/NI AR and registered-device/conformity conditions apply; performance-evaluation IVDs excluded. No claimed new1Apr2026 tariff-effective date. | £75 | $100 | Per order (first 10 certificates) | Verified |
| Regulatory advice meeting (outside the clinical-investigation meeting branches) Reg56E charges £987 for each hour, unless the separate clinical-investigation advice fee under reg56(3B)(a) or NI Protocol reg17A(2)(a) applies. CI advice under56(3B)(a) remains £987 per meeting. No small-company easement for device regulatory advice is stated. | GBP 987 | $1,319 | Per hour | Verified |
| Clinical-investigation statistical review meeting Reg56(3B)(b) applies to an intended clinical investigation under16(1A)/29(1A), payable before the meeting. This is not any statistical review or an IVD performance-study tariff. | GBP 852 | $1,138 | Per clinical-investigation statistical review meeting | Verified |
| UK Approved Body - initial designation application Payable by an applicant conformity-assessment body under reg54(1)(b), not a device manufacturer per product. The separate qualifying re-application rate and audit charges are distinct; this row covers the initial designation application. | GBP 41,337 | $55,236 | Per application | Verified |
| UK Approved Body - initial designation audit Payable by the conformity-assessment body under reg54(3) for the relevant inspection. Reg54(3A) adds staff site-time, travel-time and actual specified travel/accommodation/subsistence/out-of-pocket expenses; do not present this base as the final all-in total. | GBP 67,606 | $90,338 | Per initial designation audit, base charge plus statutory additions | Verified |
| UK Approved Body - surveillance Payable by the conformity-assessment body under reg54(3) for the relevant inspection. Reg54(3A) adds staff site-time, travel-time and actual specified travel/accommodation/subsistence/out-of-pocket expenses; do not present this base as the final all-in total. | GBP 52,929 | $70,726 | Per noninitial surveillance inspection, base charge plus statutory additions | Verified |
| UK Approved Body - published auditing day rate MHRA current table7b publishes £1,463/day. Revised UK MDR54(3A)(a)(i) separately states £732 per member-of-staff half-day, counting part half-days and maximum2 per date, plus £198 per travel hour and specified expenses. These published units are preserved without rounding one into the other; confirm the applicable statutory invoice basis. Not a per-device charge. | GBP 1,463 | $1,955 | Per published auditing day rate (see statutory half-day basis in notes) | Verified |
Government fees only — service and testing costs are separate- The £300 registration charge is per manufacturer/account chargeable GMDN Level 2 category (Level 1 where none exists), with annual/category grouping and pro-rata rules. It is not a risk-class or per-product variation price.
- For 1 April 2026 to 31 March 2027, MHRA recalculated annual fees to exclude applicable put-into-service-only registrations. Outstanding annual fees for devices placed on the market must be paid by 6 November 2026; unpaid accounts after that date are suspended. The former 31 July deadline is superseded.
- Ordinary Northern Ireland MD/IVD registration uses EUDAMED since 28 May 2026; the remaining MHRA custom-made branch is separate. Do not call the MHRA GMDN charge an NI EUDAMED fee.
- Clinical-investigation notification and statistical-review rows are MD transactions, not IVD performance-study or ordinary device-change fees. Qualifying lower-rate resubmissions are limited to addressing refusal/withdrawal grounds.
- Current MHRA clinical guidance states no amendment fee in its GB amendments section. The captured revised UK MDR reg 56(3A) nevertheless retains Group A £226 / Group B £361 amendment tariffs. Preserve the published collection guidance versus statutory-text distinction; neither proves a universal product-variation zero fee.
- The clinical-investigation waiver programme offers at most ten waivers from 20 April 2026 until 5 April 2027 or until allocated, one per eligible applicant. Eligibility includes UK micro/small status confirmed by MHRA before application, the stated innovative-device criteria and class conditions; active implantables are excluded. This does not confirm remaining availability or waive medicine-trial charges.
- General regulatory advice under reg 56E is £987 per hour, excluding the separate clinical-investigation advice meeting branches. Clinical-investigation advice under reg 56(3B)(a) is £987 per meeting; statistical-review meetings under 56(3B)(b) are £852. These are separate transactions.
- Approved-body designation/audit/surveillance fees are payable by the assessment body, not a manufacturer’s device registration or variation tariff. Audit/surveillance base charges have additional statutory staff-time/travel/expense components.
- The current MHRA table publishes £1,463 as the auditing day rate. Revised reg 54(3A) separately states £732 per staff half-day (part half-day counts, maximum two per date), £198 per travel hour and specified expenses. No rounding or conversion is used to reconcile these different published units.
- UKCA/accepted-CE market-transition dates and CFS export requirements remain separate from fee payment. A CFS is a separately requested export order, not a routine variation fee.
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Listed amounts verified individually; a universal registration fee is not asserted · full review 2026-10-21 · row IDs are stable — cite as government-fees:uk:medical-device-registration-statutory-fee