UK MHRA Medical Device Registration Guidance: Key Requirements for Great Britain and Northern Ireland

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on registering medical devices for placement on the market in Great Britain and Northern Ireland. The update, dated 11 November 2026, provides clarification on 2026/2027 annual fees, suspended registration accounts and the actions required when annual fee payments have been made but the corresponding application has not been submitted through the Device Online Registration System (DORS).

1. Medical Device Registration Requirements

Medical devices, including in vitro diagnostic devices (IVDs), custom-made devices and systems or procedure packs, must meet the applicable registration requirements before being placed on the Great Britain market.

Manufacturers must register applicable Class I, IIa, IIb and III devices, IVDs, custom-made devices and relevant systems or procedure packs with the MHRA.

Manufacturers based outside the UK must appoint a UK Responsible Person (UKRP), who assumes responsibility for registering their devices with the MHRA.

Importantly, MHRA registration does not represent product approval, certification, accreditation or endorsement.

2. Great Britain and Northern Ireland Registration

The registration requirements differ between Great Britain and Northern Ireland.

• Great Britain: Medical devices must be registered with the MHRA before being placed on the market in England, Wales and Scotland.

• Northern Ireland: From 28 May 2026, medical devices other than custom-made devices must be registered in EUDAMED before placement on the Northern Ireland market. Separate MHRA registration is no longer required for these devices.

• Custom-made devices: These must continue to be registered with the MHRA within 28 days of being made available on the Northern Ireland market.

• Authorised Representatives: Manufacturers based in Great Britain must appoint an EU- or Northern Ireland-based Authorised Representative to place devices on the Northern Ireland market.

3. Device Registration Information and DORS

Manufacturers must create an account in the MHRA Device Online Registration System (DORS) and submit the required organisation and device information.

Key information includes:

• Manufacturer's legal name, address and contact details.

• Device classification and applicable legislation.

• Global Medical Device Nomenclature (GMDN) code and term.

• Device name, model, catalogue/reference number and UDI details, where applicable.

• UK Approved Body or EU Notified Body details, where applicable.

• Relevant conformity assessment certificates or self-certification declarations.

Registration is only confirmed after the device information has been submitted and MHRA confirmation has been received. The MHRA may request additional technical documentation during its review.

4. Updated 2026/2027 Registration Fees

The MHRA introduced a revised annual fee structure from 1 April 2026, replacing the previous one-off registration fee model.

Key requirements include:

• The annual fee is calculated according to the number of Level 2 GMDN categories registered, or Level 1 categories where no Level 2 category exists.

• The fee for 1 April 2026 to 31 March 2027 is £300 per year per applicable GMDN category.

• Registrations made during the charging period are subject to a pro-rata annual fee.

• The 2026/2027 annual fee recalculation excludes applicable devices that are put into service only.

• Payments must be made through DORS, with the correct payment reference used for bank transfers.

The deadline for outstanding 2026/2027 annual fee payments was 6 November 2026. Accounts with unpaid annual fees after this date have been suspended. Where payment has already been made but the annual fee application was not submitted in DORS, the application must be completed to restore the account's registered status.

5. Reviewing and Updating Registrations

Manufacturers must regularly review their registration information and notify the MHRA of changes as they occur.

Changes that may attract statutory fees include adding devices under new GMDN categories, changing certain device characteristics, changing applicable legislation, changing the UK Responsible Person and adding represented manufacturers.

Changes such as updating company addresses, contact details, adding products to existing registered devices and removing devices may be made without a statutory fee, subject to the conditions specified in the guidance.

The previous DORS renewal function was removed on 1 April 2026. However, manufacturers remain responsible for regularly reviewing their registration information to maintain regulatory compliance and ensure correct fee calculations.

6. Additional Registration Considerations

The MHRA guidance also addresses registration requirements for:

• Medical devices relying on extended validity of expired or expiring CE certificates under applicable EU MDR transitional arrangements.

• Certain EU MDD Class I reusable surgical instruments and devices upclassified under the EU MDR.

• IVDs relying on extended validity of expired or expiring CE certificates under EU IVDR transitional arrangements.

• IVDs upclassified under the EU IVDR.

• IVDs undergoing performance evaluation studies, which must be registered by the relevant responsible party by the time the study commences.

Registered manufacturer and device information is made available through the MHRA Public Access Registration Database (PARD), with device identification supported by GMDN terminology.

Reference:

• MHRA – Register Medical Devices to Place on the Market – Last updated 11 November 2026.