Keeping registration up to date
MHRA registration maintenance obligations derive from the registration provisions of the UK MDR 2002 as amended by SI 2019/791 and MHRA's registration guidance. Registration must remain current throughout the period a device is on the GB market.
Registration is not a one-time event
MHRA registration must remain current and accurate throughout the period a device is placed on the GB market. Registration is not completed once at market entry and then forgotten — it is a living record that must reflect the current status of the manufacturer, UKRP, and devices.
Changes that require registration update
Manufacturer/UKRP changes
| Change | Action required |
|---|---|
| Manufacturer name change (e.g., following merger or acquisition) | Update MHRA registration — notify via Submissions portal |
| Manufacturer address change | Update MHRA registration |
| Change of UKRP | Deregister the previous UKRP; register the new UKRP; update device registrations to the new UKRP |
| UKRP address change | Update UKRP registration |
| Cessation of device supply in GB | Update registration to reflect that the device is no longer on the market |
Device-level changes
| Change | Action required |
|---|---|
| New device model added to an existing registered product line | Register the new model |
| Change in device classification | Update registration to reflect new classification |
| New UKAB certificate (following certificate renewal or new certification) | Update certificate reference in registration |
| Device withdrawn from the GB market | Update registration to indicate withdrawal |
| Change in CE marking status (for devices relying on CE transitional acceptance) | Update certificate reference |
How to update registrations
All registration updates are completed via the MHRA Submissions portal at submissions.mhra.gov.uk.
Log in with existing credentials, navigate to the relevant registration record, and submit the update. MHRA may review changes and contact the registrant for clarification.
Consequences of outdated registration
Failure to maintain current MHRA registration can:
- Constitute a violation of UK MDR 2002 obligations
- Complicate FSCA and recall management (if contact details are outdated, MHRA cannot reach the UKRP efficiently)
- Lead to MHRA enforcement action
- Jeopardise UKAB certificate validity (UKABs verify that MHRA registration is current as part of surveillance)
Related pages
Official references
| Reference | Description |
|---|---|
| UK MDR 2002 as amended | Registration obligations |
| MHRA: Registering medical devices | Registration and maintenance guidance |