Medical Device Registration Fees (UKCA Marking)
MHRA fees for medical device manufacturer and device registration
- Statutory registration fee
- £300 per Level 2 GMDN Category (or Level 1 where no Level 2 exists), applicable since 1 April 2026
- Device registration requirement
- All devices placed on UK market must be registered
- Registration update deadline
- 10 working days for any changes
- Technical file retention
- Minimum 10 years after last device placed on market
- UK Responsible Person (UKRP)
- Mandatory for non-UK manufacturers
- Clinical investigation fee (Class I and IIa)
- £15,309
- Clinical investigation fee (Class IIb implantable/long-term invasive)
- £24,617
- Clinical investigation fee (Class III and active implantable)
- £32,016
- Clinical investigation amendment fee
- £0 (no fee for amendments from 16 July 2025)
- Average clinical investigation approval time
- 51 calendar days