MHRA Updates Guidance on Registering Medical Devices for the UK Market
The Medicines and Healthcare products Regulatory Agency has updated its guidance “Register medical devices to place on the market”, last updated on 20 July 2026.
The guidance explains how medical devices, including in vitro diagnostic devices, custom-made devices, and systems or procedure packs, must be registered with the MHRA before being placed on the market in Great Britain.
Devices placed on the Great Britain market must comply with the Medical Devices Regulations 2002, as amended, also known as the UK MDR 2002.
Registration for Great Britain
The MHRA confirms that companies must register devices before placing them on the Great Britain market.
This includes Class I, IIa, IIb and III devices, IVDs, custom-made devices, systems or procedure packs, refurbished or re-labelled devices, and IVDs undergoing performance evaluation.
Where the manufacturer is based outside the UK, a single UK Responsible Person must be appointed to take responsibility for registration with the MHRA.
The guidance also reminds stakeholders that registration does not represent MHRA accreditation, certification, approval or endorsement.
Placing on the Market and Putting into Service
The guidance clarifies the difference between placing on the market and putting into service.
A device placed on the Great Britain market must be registered with the MHRA before it is made available.
Where a device is only put into service, for example where a hospital makes and uses its own device on site without marketing or distribution, MHRA registration is encouraged but not required.
Northern Ireland Requirements
Registration requirements differ for Northern Ireland.
Since 28 May 2026, all medical devices other than custom-made devices must be registered on EUDAMED before placement on the EU and Northern Ireland markets. From that date, MHRA registration is no longer required for those devices.
Custom-made devices must continue to be registered with the MHRA for the Northern Ireland market.
Device Information, DORS and Fees
The guidance sets out the information needed for MHRA registration, including manufacturer details, device classification, applicable legislation, GMDN code and term, device name, model or version, UDI-DI where applicable, and conformity assessment documentation.
Registrations are submitted through the Device Online Registration System.
The MHRA also highlights the new fee structure introduced on 1 April 2026. The Annual Fee payment deadline has been extended to 31 July 2026, and the unit cost from 1 April 2026 to 31 March 2027 is £300 per year per applicable GMDN category.
Updating Registrations
Manufacturers and registration holders must ensure that MHRA registration information remains accurate and up to date.
The guidance explains that some changes may be chargeable, including adding devices under a new GMDN category, changing device characteristics, changing applicable legislation, changing UK Responsible Person or adding represented manufacturers.
Other updates, such as address changes, contact updates, removing devices or products, updating obsolete GMDN codes or adding importers, may be free of charge.
Impact on Medical Device and IVD Manufacturers
For medical device and IVD manufacturers placing devices on the UK market, the updated guidance reinforces the need to maintain accurate and current registration data.
Manufacturers should pay particular attention to:
Great Britain registration obligations before placing devices on the market;
the role of the UK Responsible Person;
Northern Ireland requirements and EUDAMED registration;
custom-made device requirements;
GMDN and UDI information;
conformity assessment documentation;
registration of IVDs undergoing performance evaluation;
CTDA requirements for coronavirus test devices;
annual fees and chargeable registration changes.
For manufacturers, the guidance highlights that MHRA registration is an ongoing regulatory responsibility, not a one-off administrative step.
