What it is
What is MHRA device registration?
The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK authority responsible for regulating medical devices. Since Brexit, medical devices and IVDs must be registered with the MHRA before being placed on the Great Britain market.
- The device meets UK safety and performance requirements
- The manufacturer is traceable
- Patients and clinicians are protected through proper oversight
Who must register
Who must register their devices?
- UK-based manufacturers of medical or IVD devices
- Non-UK manufacturers — via a UK Responsible Person (UKRP)
- Covered: general medical devices (Class I, IIa, IIb, III), IVDs, custom-made and active implantable devices, and software-based devices
Without registration, a device cannot legally be placed on the Great Britain market.
Markings
UKCA, CE & UKNI — what’s the difference?
| Mark | Where | Purpose |
|---|---|---|
| UKCA | Great Britain | UK conformity marking introduced after Brexit |
| CE | EU & Northern Ireland | Required in NI; accepted in GB under transitional arrangements |
| UKNI | Northern Ireland | Used alongside CE when a UK Notified Body performed the assessment |
CE acceptance timelines in Great Britain depend on the legislation your device is certified under — we confirm the current position for your specific device.
Process
Step-by-step MHRA registration
- 01Create a DORS accountRegister on the MHRA Device Online Registration System portal.
- 02Appoint a UKRPNon-UK manufacturers appoint a UK Responsible Person.
- 03Upload device detailsDevice information, technical documentation and labeling.
- 04Pay the fee & submitPay the registration fee and submit through the portal.
- 05ApprovalMHRA review typically completes within 5–10 working days of a complete submission.
UK Responsible Person
What does a UKRP do?
If you are based outside the UK you must appoint a UK Responsible Person, physically located in the UK, to act on your behalf.
- Register your devices with the MHRA
- Hold copies of your technical documentation
- Cooperate with the MHRA during audits or investigations
- Report incidents and field safety corrective actions
Documentation
Required documentation
- Declaration of Conformity
- Technical file (risk analysis, device description, etc.)
- Labeling and packaging information
- CE / UKCA certificates where applicable
- GMDN or UDI codes
- Manufacturer and authorized representative details
All documents must be in English and up to date.
After registration
Post-registration obligations
- Keep technical files up to date
- Monitor post-market performance under the GB post-market surveillance requirements
- Report adverse incidents to the MHRA
- Notify the MHRA of significant changes (labeling, manufacturer, intended use)
- Keep registrations current in line with MHRA guidance
How we help
Our MHRA services
- MHRA DORS device registration
- UK Responsible Person (UKRP) setup
- UKCA / CE / UKNI marking strategy
- Technical documentation and labeling review
- Post-market surveillance and vigilance support
01
Experienced team
We have helped 100+ clients register devices with the MHRA.
02
Fast turnaround
Complete submissions prepared in under five working days.
03
Complete support
UKRP setup, document review and labeling compliance.
04
Transparent pricing
Clear packages for startups, agencies and enterprises.
The regulatory journey
From regulatory strategy to MHRA approval
- 01Framework identificationWe confirm the regulatory pathway that applies to your product and target market — MDSAP, MDR, FDA, TGA or MHRA.
- 02Regulatory strategyDevice classification, pathway selection and a realistic timeline to support launch planning.
- 03Technical documentationRisk management, clinical/performance evidence, labeling and QMS records built to each authority’s expectations.
- 04Submission and liaisonWe prepare and submit the application, manage questions from the authority or Notified Body, and track progress.
- 05Approval and market accessClearance, CE or UKCA marking, ARTG inclusion or registration, enabling your product to be placed on the market.
- 06Post-market complianceOngoing surveillance, vigilance, periodic updates and renewals to maintain compliance.
