UK MHRA Guidance: Register Medical Devices to Place on the Market

Sharan Murugan
Jun 27
3 min read

Manufacturers who intend to place medical devices on the market in Great Britain or Northern Ireland must comply with the registration requirements established by the Medicines and Healthcare products Regulatory Agency (MHRA). The Register Medical Devices to Place on the Market guidance explains which devices require registration, who is responsible for registration, applicable timelines, registration procedures, and the associated fees. It also outlines the differences in regulatory requirements between Great Britain and Northern Ireland following changes to the UK regulatory framework.

Who Must Register Medical Devices?

Medical devices that are placed on the Great Britain market must generally be registered with the MHRA before they can be supplied. Depending on the manufacturer's location, the responsibility for registration may rest with the UK manufacturer or the appointed UK Responsible Person (UKRP) for manufacturers established outside the UK.

Who needs to register medical devices?

Medical Devices Requiring Registration: The guidance applies to a broad range of medical devices, including:

General medical devices
Active implantable medical devices
In vitro diagnostic (IVD) medical devices
Custom-made devices (subject to applicable requirements)
Systems and procedure packs where registration requirements apply

Manufacturers should ensure that only devices meeting the applicable regulatory requirements are registered before being placed on the relevant UK market.

Registration Requirements for Great Britain

For the Great Britain market (England, Scotland, and Wales), manufacturers must register eligible medical devices with the MHRA through the Device Online Registration System (DORS).

The guidance explains that manufacturers based outside the UK must appoint a UK Responsible Person before registration can be completed. The UK Responsible Person is responsible for submitting and maintaining the device registration on behalf of the overseas manufacturer.

Registration Requirements for Northern Ireland

The regulatory requirements for Northern Ireland differ from those applicable in Great Britain.

The guidance explains that registration obligations depend on factors such as:

The type of medical device
Applicable conformity assessment procedures
Regulatory pathway used for placing the device on the Northern Ireland market

Manufacturers should carefully determine whether MHRA registration is required based on the applicable Northern Ireland regulatory framework.

Information Required During Registration

When registering a medical device, manufacturers or UK Responsible Persons are required to provide information that enables the MHRA to identify both the manufacturer and the registered devices.

The information requested includes details relating to:

Manufacturer information
UK Responsible Person (where applicable)
Device identification
Device classification
Relevant conformity assessment information
Product nomenclature and supporting registration details

Accurate and complete information is important to support successful registration and ongoing regulatory compliance.

Device Online Registration System (DORS)

The MHRA uses the Device Online Registration System (DORS) to manage medical device registrations.

Through DORS, manufacturers and UK Responsible Persons can:

Register new medical devices
Update existing registrations
Maintain registration records
Manage account information
Complete registration-related activities

The guidance encourages users to keep registration information current throughout the product lifecycle.

Registration Fees

The guidance explains that manufacturers are subject to annual registration fees based on the applicable Global Medical Device Nomenclature (GMDN®) Level 2 category (or Level 1 where no Level 2 category exists).

The annual fee applies per chargeable category rather than per individual device. If multiple devices fall within the same chargeable category, only one annual fee applies for that category during the charging period.

For registrations submitted during the financial year, fees are calculated on a pro-rata basis.

The guidance also notes that the payment deadline for the Annual Fee has been extended to 31 July 2026.

Maintaining Registration

Manufacturers are responsible for ensuring that their registration information remains accurate after registration.

Where relevant, changes should be submitted through DORS so that registration records remain current and fee calculations accurately reflect registered devices.

Regular review of registration information is recommended to support continued regulatory compliance.