UK Med Dev Guidance: Comprehensive Guide to Registering Medical Devices in Great Britain and Northern Ireland

With the regulatory landscape evolving in the UK post-Brexit, manufacturers, importers, distributors and authorised representatives must be fully aligned with the registration requirements laid out by the MHRA. The guidance titled “Register medical devices to place on the market” sets out the detailed steps, legal framework, responsibilities and timelines you must meet for compliant market entry.

Under the guidance, every medical device (including in-vitro diagnostics (IVDs), custom-made devices, systems or procedure packs) that is to be placed on the Great Britain market (England, Wales, Scotland) must be registered with MHRA before being placed on the market.

Key parties:

• Manufacturers based in UK – direct registration.

• Manufacturers outside UK – must appoint a UK Responsible Person (UKRP) who acts on behalf of the non-UK manufacturer to register devices with MHRA.

• Importers and distributors – while their registration may not be required in all cases, they must ensure that the device they place on market is registered and the manufacturer/UKRP obligations are met.

The registration must be completed before the device is placed on the market in Great Britain. The guidance emphasises that you are not legally permitted to market a device in Great Britain without MHRA registration.

Registration Requirements

The guidance outlines the key data you must provide via the MHRA Device Online Registration System (DORS).

Typical information includes:

• Manufacturer name, address, contact details.

• UK Responsible Person name (if non-UK manufacturer).

• Device name, model, classification (risk class I, IIa, IIb, III; IVD lists).

• Conformity assessment information: e.g., CE certificate number or UKCA certificate, UK Approved Body if applicable.

• Global Medical Device Nomenclature (GMDN) code.

• Intended purpose, sterilisation status, measuring function, etc (which affect classification).

• Any changes to registrations: updates, cancellations, modifications must be reported.

Fees and Renewal

• Statutory registration fees apply per application.

• The MHRA charges an annual fee starting April 1, 2026, based on Level 2 GMDN device categories registered.

• Up to 100 GMDN codes or 20,000 device product variations can be registered per application.

• Fees cover additions, modifications, and renewals.

• Failure to renew or update registrations by their due date can result in suspension, blocking market access.

Special Considerations

• Coronavirus Test Devices: Must obtain separate approvals from the UK Health Security Agency (UKHSA) before MHRA registration.

• Registration of Legacy Devices: Transitional measures exist for devices with expired CE certificates under EU MDR or EU IVDR.

• Borderline Products: Guidance is available to determine if a product qualifies as a medical device or falls under other regulatory frameworks.

  
  

Once registered, manufacturer and device details are made publicly available on the MHRA Public Access Registration Database (PARD) to facilitate transparency in the marketplace and stakeholder awareness.

For more details, please refer to the MHRA guidance: Register medical devices to place on the market