MHRA registration

All medical devices must be registered with MHRA and obtain a UK Conformity Assessment (UKCA) mark before they can be placed on the UK market.

Registration must be carried by a manufacturer or designated 'responsible person' (often a Clinical Safety Officer) who is based in the UK.

A statutory fee applies (£240, as of 03/August/2023). Registration of a device with the MHRA does not represent any form of approval and no claims to this effect are permitted in any device-related materials.

MHRA has issued detailed guidance on medical device registration for manufacturers. You can also refer to our case studies.

The following information is required when registering:

Manufacturer details (legally liable entity)

• company type (e.g. limited company, exempt charity)
• administrative contact
• a letter of designation (i.e. legal contract) for the UK Responsible Person (often a Clinical Safety Officer)

Device details

• The device class (I, IIa, IIb, III)
• A Global Medical Devices Nomenclature (GMDN)® Code and Term (a standardised vocabulary) description of the device
• A Unique Device Identifier based on the EU UDI-DI identification system for medical devices
• The medical device name (brand/trade/proprietary name)
• The device model or version details
• The manufacturer's internal catalogue or reference number
• The relevant UK Approved Body used for UKCA marking (i.e. details of the organisation used to conduct UK conformity assessments, which must be approved by MHRA).