MHRA DORS Medical Device Registration: Step-by-Step for Great Britain

Quick answer

Before you place a medical device on the Great Britain (England, Wales, and Scotland) market, you must register it with the Medicines and Healthcare products Regulatory Agency (MHRA) through the Device Online Registration System (DORS). UK-based manufacturers register directly; manufacturers based outside the UK must appoint a UK Responsible Person (UKRP) who registers on their behalf. Registration is a pre-market obligation under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)—you are not lawfully on the GB market until DORS confirms the device registration. MHRA registration is not product approval; it is a statutory notification requirement. Fees apply per GMDN Level 2 category (or Level 1 where no Level 2 exists) under the annual fee structure effective from 1 April 2026.

Who this applies to

This workflow applies to any person or company that sells, leases, lends, or gifts on the GB market:

• Class I, IIa, IIb, or III medical devices they have manufactured
• Devices they have refurbished or re-labelled with their own name
• Systems or procedure packs containing at least one medical device
• Custom-made devices
• In vitro diagnostic medical devices (IVDs) they have manufactured
• IVDs undergoing performance evaluation in the UK

It also applies to UK Responsible Persons representing non-UK manufacturers, and to Northern Ireland-based Authorised Representatives where NI registration rules require MHRA registration. Distributors that do not import devices for GB placement are generally not required to register with the MHRA themselves, though GB importers must notify the manufacturer or UKRP so importer details can be submitted.

Devices must conform to UK MDR 2002 as it applies in Great Britain (with current transitional acceptance of qualifying CE-marked devices per GOV.UK timelines) before registration and market placement.

What is DORS?

DORS (Device Online Registration System) is the MHRA's online portal for medical device registration and related account management. It replaced legacy registration processes for most customers and is the only channel through which statutory registration fees should be paid.

Key characteristics of DORS:

• Account-based access — you request an account; MHRA emails acceptance or rejection before you can register devices.
• Single account for GB and NI — one DORS account can cover registrations for both Great Britain and Northern Ireland where applicable.
• Confirmation required — you are not regarded as registered until device details are submitted and MHRA confirms registration. MHRA may request additional technical documentation during scrutiny.
• Public listing — confirmed registrations appear on the Public Access Registration Database (PARD), showing manufacturer name, address, MHRA reference number, GMDN terms, and brand/trade names (IVDs under performance evaluation are not published).
• Reference guides — MHRA publishes Account Management and Device Registration reference guides (April 2026 editions) plus video tutorials for common DORS tasks.

DORS does not substitute for conformity assessment, UKCA or CE marking, or post-market surveillance obligations. It is the registration layer that sits alongside those requirements.

UK Responsible Person: who registers for non-UK manufacturers

Under GOV.UK guidance on regulating medical devices in the UK, the MHRA only accepts device registrations from manufacturers based in the UK. If the manufacturer is established outside the UK, they must appoint a single UK Responsible Person (UKRP) for all their medical devices.

The UKRP then:

• Assumes the manufacturer's registration obligations in DORS
• Must provide a letter of designation — a legal contract stating they are the exclusive UKRP and specifying mandatory contracted tasks per MHRA UKRP guidance
• Registers devices before they are placed on the GB market
• Must appear on labelling (product, outer packaging, or IFU) when a UKCA mark is affixed; UKRP details are not required on labelling for CE-marked-only devices unless the device bears both CE and UKCA markings

Important account status note: Accounts of former Great Britain-based Authorised Representatives that have not updated their role to UK Responsible Person on DORS—and associated manufacturer accounts—have been suspended since 1 January 2022. If the role is not updated by 30 March 2026, the account will be closed and a new account must be created.

Importers and distributors do not need to appoint a UKRP, though an importer or distributor may act as the UKRP if they meet the contractual and regulatory requirements.

When to register: pre-market timing

Registration is required before placing a device on the GB market. UK MDR 2002 requires you to inform the MHRA before market placement—not after first sale or first import.

Specific timing triggers include:

After registration, you must keep information accurate and up to date. Regulations 7A, 19, 21A, 21B, 33A, and 44 of UK MDR 2002 (and NI Regulations 2021 where applicable) require notification of changes. The former Renew registration function was removed from DORS on 1 April 2026; frequent review remains a legal requirement.

Information required in DORS: manufacturer and device fields

Before registering, confirm your product meets the medical device or IVD definition in Regulation 2 of UK MDR 2002. If uncertain—especially for self-certified Class I devices—consult MHRA borderline guidance or email devices.borderlines@mhra.gov.uk.

Manufacturer and account fields

• Legal entity name and address as shown on device labelling/packaging
• Company type (e.g. limited company, sole trader)
• Administrative contacts — up to 15 people with account access
• Letter of designation for UKRP (legal contract with mandatory tasks listed in UKRP guidance)
• For NI registrations: written mandate from manufacturer or NI Authorised Representative meeting EU MDR 2017/745 and/or EU IVDR 2017/746 requirements

UKRP and NI Authorised Representative accounts must also add represented manufacturer details before device registration proceeds.

Device and product fields

For each device registration, DORS requires (non-exhaustive list per GOV.UK):

You can register up to 100 devices (GMDN) with a cumulative maximum of 20,000 products (brand name, model, catalogue, UDI-DI combinations, etc.) in each application.

For systems and procedure packs, register each pack using GMDN, add at least one underlying product, and upload a list of possible components. Separate rules apply to sterilisation of packs under your own name.

MHRA publishes a detailed Manufacturer and Device and Product and Importer Attributes spreadsheet on GOV.UK for field-level mapping.

Importer details (GB)

Where a GB-based importer is not the UKRP, the importer must inform the manufacturer or UKRP of intent to import. The manufacturer or UKRP must submit the importer's place of business in Great Britain to the MHRA via DORS. Adding or deactivating importers is a free change in DORS.

Fees: what to expect from 1 April 2026

MHRA replaced the previous one-off registration fee regime with an annual fee structure from 1 April 2026:

• £300 per year per Level 2 GMDN® Category (or Level 1 Category where no Level 2 exists) for the period 1 April 2026 to 31 March 2027 — fee changes annually
• Multiple GMDN codes/products under the same Level 2 category are charged once per year for that category
• Products spanning multiple Level 2 categories are still charged once per year per the GOV.UK fee rules
• Registrations made mid-year (1 April–31 March) incur pro rata annual fees
• Fee calculation uses categories registered on the account on 31 March each year
• Pay only through DORS; BACS/CHAPS payments must include the unique DORS reference or processing delays and account suspension may occur

Chargeable changes include adding devices in a new GMDN Level 2 category, certain characteristic changes requiring re-registration, UKRP changes, and adding represented manufacturers. Free changes include address updates, adding products to existing registered devices, uploading new conformity documents consistent with original legislation, and importer add/deactivate actions—see GOV.UK "Making changes to your registration" for the full list.

As of 26 June 2026, GOV.UK notes the annual fee payment deadline was extended to 31 July 2026. Always verify current fee...