Regulations
In medical devices or in vitro diagnostic medical devices (IVDs) on the market in great britain (england, scotland, and wales) and northern ireland regulatory requirements to the medicines and healthcare products regulatory agency registration process. In April 2026, significant updates to the fee structure and the device online registration system were implemented. In overview of the current requirements based on official gov.uk guidance below.
The primary regulatory requirement for medical devices in great britain is the UK medical devices regulations 2002.
Great Britain (GB): Devices must meet the requirements of UK MDR 2002. While the UKCA (UK conformity assessed) mark is the standard, the MHRA currently continues to valid CE marks under transitional arrangements.
Northern Ireland (NI): The northern ireland protocol and windsor framework, EU MDR and EU IVDR still apply. However, MHRA registration is still required for many medical devices placed on the Northern Ireland market until May 28, 2026. After this date you will need a registration. It is the regulatory requirement for that region. EUDAMED registration is important.
WHO MUST REGISTER?
To access the market, legal registration is required.
UK-based manufacturers: must register themselves and their devices directly with the MHRA.
Non-UK manufacturers: must appoint a uk responsible person. The uk responsible person is a legal individual based in the united kingdom that acts on behalf of the manufacturer to handle registrations and maintain technical documentation.
Importers/distributors: while they do not usually register devices, they must ensure the manufacturer or uk responsible person has completed the registration before the device is placed on the market.
REQUIRED DOCUMENTATION
To complete a registration through the MHRA’s DORS portal, the following documents and information must be submitted
FEES (2026 UPDATE)
Starting on April 1 2026 the MHRA made a change in the registration process. They used to charge a one time fee for an application. Now the MHRA charges a fee. This new system helps the MHRA keep the registration system running efficiently. The MHRA does this to make sure the registration system is acceptable. The MHRA wants the registration system to keep working.
New Registration Fee: £300 for each application submitted.
Annual Maintenance Fee: £300 per device, or per GMDN Level 2 category, depending on how the device group is classified.
Administrative Changes: basic updates like address changes. This applies to all accounts where the legal structure remains unchanged.
Payment Timeline: Invoices generated via the DORS system must be paid within 90 days. Failure to pay results in account suspension and removal from the Public Access Registration Database (PARD).
REGISTRATION TIMELINE
Submission Preparation: Usually takes around 1 to 2 weeks to complete the required technical documentation and GMDN codes.
MHRA Review Process: The MHRA process completes applications within approximately 10 working days.
Approval & Market Access: Once the registration is approved, the device is immediately listed on the PARD database, legal commercialization in the UK.
March 30, 2026:The deadline for manufacturers to update and verify their GMDN codes and account information is before the fee structure takes effect in 2026 .
May 28, 2026: Significant regulatory change is coming to the Northern Ireland market. Most medical devices excluding custom-made devices will now use EUDAMED registration.
Important Note: When you use the UKCA marking you need to make sure that the information about your UK Person is on the product label or in the instructions that tell people how to use the product. If you have a product with the CE marking it is not necessary to include the UK Responsible Person details.
To commercialize your medical device in the united kingdom, requirements must be met. We ensure your pre market submission should meet the requirements. Our team helps you prepare and verify the following essential components:
Confirm device classification accurately under local UK MHRA regulation.
To sell a product you need to get a Free Sale Certificate from the country where it was made.
You have to make a Declaration of Conformity and sign it.
Your ISO 13485 and MDSAP certificate must be up to date.
The product label and the instructions on how to use it must be in English.
You have to make a Technical File or a Design Dossier that meets the UK MDR 2002 rules.
If the product needs it you also have to make a Clinical Evaluation Report.
Confirm UDI assignment for traceability.
Ensure CE or UKCA Mark is explicitly in place before initiating DORS and your final device registration
Who is required to register medical devices with the MHRA?
All medical devices and IVDs placed on the UK market must be registered with the MHRA. UK-based manufacturers can register their devices directly. Non-UK manufacturers are legally required to appoint a UK responsible person (UKRP) to manage the registration process on their behalf.
What are the new MHRA registration fees for 2026?
Effective from April 1, 2026, the MHRA introduced an updated fee structure that includes: New Registration Fee: £300 per application Annual Maintenance Fee: £300 per device or GMDN Level 2 category. Failure to pay invoices within 90 days may result in account suspension and removal from the public MHRA database.
Is a CE mark still accepted in Great Britain?
Yes. Although the UKCA mark is the primary conformity marking for Great Britain (England, Scotland, and Wales), the MHRA continues to accept valid CE-marked devices under transitional arrangements. However, when using the UKCA mark, UK Responsible Person (UKRP) details must be included on the product labeling or Instructions for Use (IFU).
What documentation is required for a DORS submission?
To complete a registration through the device online registration system (DORS), the following documents and details are typically required: manufacturer information: legal entity name and registered address, device details: applicable level 2 gmdn codes, conformity documents: signed declaration of conformity (UKCA or CE) and relevant certificates, UKRP authorization: letter of designation for non-uk manufacturers
How long does the MHRA registration process take?
The MHRA registration process generally includes two stages: Preparation Stage: Approximately 1 or 2 weeks to collect technical documentation and identify correct GMDN codes. MHRA Review Stage: Applications are usually processed within 10 working days after submission. Once approved, the device is immediately listed in the MHRA public database and can be legally marketed in the UK.
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