Geographic route
Will the device be supplied in Great Britain, Northern Ireland or both, and which legal framework applies to each destination?
United Kingdom regulatory market
UK market access for medical device software.
We help software medical device teams understand the UK route, prepare registration and technical evidence, coordinate UK Responsible Person requirements and build post-market processes for Great Britain.
Discuss your market plan →Pathways and services
Regulatory support for United Kingdom.
Technical documentation
EU MDR and CE marking support
CE technical documentation and conformity planning that can remain relevant under UK recognition arrangements and for Northern Ireland.
View service →EvidenceClinical evidence strategy
Claims, clinical evaluation and performance evidence planned for the applicable UK route.
View service →Use safetyHuman factors and usability
Use-related risk and interface evidence aligned with the device, users and operating environment.
View service →LifecyclePost-market surveillance
Complaint, vigilance, trend, corrective-action and change processes for Great Britain obligations.
View service →What we need to determine
The decisions that shape your application.
Device status and class
Does the intended purpose make the software a medical device under the applicable UK rules, and what classification follows?
Market-access route
Can a qualifying CE marking route be used under current recognition arrangements, or should UKCA conformity assessment be planned?
UK representation
Does the manufacturer need a UK Responsible Person, and are registration data, device scope and responsibilities aligned?
How we work
From classification to market entry.
- 1
Define the destination
Separate Great Britain and Northern Ireland routes, device scope, claims and supply-chain roles.
- 2
Select the route
Document classification, recognition or UKCA strategy, representation and conformity dependencies.
- 3
Prepare and register
Align technical evidence, labelling and registration data before placing the device on the market.
- 4
Maintain compliance
Operate post-market surveillance, vigilance, corrective action and controlled change assessment.
Core regulations, standards and guidance
UK Medical Devices Regulations 2002MHRA software and AI guidanceMHRA device registrationGB post-market surveillance regulationsISO 13485:2016ISO 14971IEC 62304IEC 62366-1Regulation (EU) 2017/745 for Northern Ireland
FAQ
Common questions about United Kingdom.
UK medical-device reforms and CE-recognition timelines continue to evolve. Great Britain and Northern Ireland requirements differ, so current legislation and MHRA guidance must be checked for each device and market action.
Is a CE mark accepted in Great Britain?+
Qualifying CE-marked devices continue to be recognised in Great Britain under transitional arrangements that depend on the device and certification route. The applicable recognition deadline and certificate status should be checked before relying on that route.
Is UKCA mandatory now?+
UKCA remains the domestic conformity-assessment route for Great Britain, but current recognition arrangements allow qualifying CE-marked devices to be placed on the GB market for defined periods. A manufacturer should compare timing, certificate dependencies and future plans rather than assume one route fits every device.
Do overseas manufacturers need a UK Responsible Person?+
A manufacturer established outside the UK must appoint a UK Responsible Person to place a device on the Great Britain market. The UK Responsible Person carries defined registration and regulatory responsibilities and should be appointed under a clear written mandate.
Are Northern Ireland requirements the same as Great Britain?+
No. Northern Ireland continues to apply EU medical-device rules under its specific arrangements. CE marking, and in some circumstances UKNI marking, may apply. A Great Britain registration strategy should not be copied into Northern Ireland without separate analysis.
What post-market rules apply in Great Britain?+
Great Britain has strengthened post-market surveillance requirements covering manufacturer systems, reporting, trend analysis and corrective action. The exact duties depend on the device and event, and should be built into the quality system before market entry.