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Annual fees

Regulatory basis

MHRA charges fees for device registration and related services under fee regulations made pursuant to the UK MDR 2002 and the Medicines and Healthcare products Regulatory Agency Act. Fee schedules are published on gov.uk and updated periodically.

Overview of MHRA fees​

MHRA charges fees for:

  • Initial device registration — when a manufacturer or UKRP first registers devices with MHRA
  • Annual registration fees — to maintain registration for devices on the GB market
  • Pre-submission meetings — advisory meetings with MHRA before submission
  • Export certificates — Certificates of Free Sale issued by MHRA for export purposes

The fee structure is tiered based on:

  • Number of devices registered
  • Device class
  • Whether the manufacturer qualifies as an SME (Small or Medium Enterprise)

Where to find current fees​

MHRA publishes its current fee schedule at:

gov.uk/guidance/register-as-a-manufacturer-to-sell-medical-devices

Always check the current schedule — fees are subject to change and this site cannot guarantee the figures remain current.

Consequences of non-payment​

Failure to pay MHRA registration fees may result in:

  • Suspension of device registrations
  • Removal of the manufacturer/UKRP from the MHRA register
  • Loss of GB market access for affected devices
  • MHRA enforcement action

SME relief​

MHRA applies reduced fees for manufacturers that qualify as SMEs under UK Government SME definitions. Evidence of SME status may be required.

Official references​

ReferenceDescription
MHRA: Registration feesCurrent fee schedule — gov.uk
MHRA: Registering medical devicesFee payment guidance