MHRA Updates Guidance on Registration of Medical Devices for the UK Market
The Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance titled “Register medical devices to place on the market” on 20 February 2026 .
The guidance sets out the requirements for registering medical devices for placement on the market in Great Britain (England, Wales and Scotland) and Northern Ireland.
Great Britain – Registration Requirement
All medical devices, including:
General medical devices (Class I, IIa, IIb and III)
In vitro diagnostic devices (IVDs)
Custom-made devices
Systems and procedure packs
IVDs undergoing performance evaluation
must be registered with the MHRA before being placed on the market in Great Britain .
Devices placed on the Great Britain market must conform to the Medical Devices Regulations 2002 (SI 2002 No. 618, as amended) .
If the manufacturer is based outside the UK, a single UK Responsible Person (UKRP) must be appointed .
Registration does not represent accreditation, certification, approval or endorsement by the MHRA. The use of MHRA logos in marketing materials or labelling is not permitted .
Northern Ireland – Registration Requirements
Registration requirements differ for Northern Ireland.
Until 27 May 2026
Certain devices placed on the Northern Ireland market must be registered with the MHRA under the UK MDR 2002, depending on:
Location of the manufacturer
Location of the authorised representative
Device class
From 28 May 2026
From 28 May 2026:
All medical devices (other than custom-made devices) must be registered in EUDAMED prior to placement on the EU and Northern Ireland markets.
MHRA registration will no longer be required for those devices.
Great Britain-based manufacturers must continue to appoint an EU or Northern Ireland-based Authorised Representative to place devices on the Northern Ireland market .
Custom-made devices must continue to be registered with the MHRA in accordance with the Northern Ireland Regulations 2021 .
Registration Fees
Until 31 March 2026
A statutory fee applies per registration application .
From 1 April 2026
From 1 April 2026:
A new annual fee will replace the current one-off registration fee regime.
Manufacturers will be charged annually based on the number of Level 2 GMDN® Categories under which their devices are registered.
If multiple devices fall within the same Level 2 GMDN® Category, only one annual fee applies for that category.
The estimated unit cost is in the region of £300 per year per Level 2 GMDN® Category.
The calculation for the 2026/27 financial year will be based on registrations held on 31 March 2026.
Registrations made between 1 April and 31 March will be charged on a pro rata basis .
Manufacturers are instructed to review their registration data and remove “Pseudo” GMDN® entries migrated from the previous DORS system. These entries will be removed from DORS on 31 March 2026 .
Review and Renewal of Registration
Until 30 March 2026, a renew registration process applies.
If the renew registration application is not submitted by 30 March 2026:
The account will be suspended.
Suspended accounts are removed from the Public Access Registration Database (PARD).
At 17:00 on 30 March 2026, accounts that remain suspended will be closed.
From 1 April 2026, the renew registration function will be removed from DORS .
Manufacturers remain legally required to ensure that all registration information is accurate and up to date .
Expired or Expiring CE Certificates
The guidance refers to:
The March 2023 revision of EU MDR transitional arrangements.
The June 2024 revision of EU IVDR transitional arrangements.
In certain circumstances, expired EU MDD, AIMDD or IVDD CE certificates may continue to be relied upon for placing devices on the Great Britain and Northern Ireland markets.
Manufacturers must upload:
A notified body letter confirming receipt of an application for conformity assessment and the conclusion of a written agreement, or
The relevant Article 120 (EU MDR) or Article 110 (EU IVDR) extension confirmation template .
Public Access Registration Database (PARD)
Once registered, the following information is published on the Public Access Registration Database (PARD):
Manufacturer name
Address
MHRA reference number
Registered medical device types (GMDN® Term)
Brand/trade names of registered devices (available from 23 February 2026)
5-digit GMDN® code
UK Responsible Person or Northern Ireland Authorised Representative details (if applicable) .
The full updated guidance (last updated 20 February 2026) is available below.
