UKRP
Responsible Person in the United Kingdom
for Medical Devices
MHRA Representation
UKRP
Non-UK manufacturers wishing to place medical devices or in vitro diagnostic devices on the Great Britain market, including England, Scotland and Wales, must appoint a UK Responsible Person (UKRP), as required by the UK Medical Devices Regulations 2002, as amended.
The UKRP acts as the official representative of the foreign manufacturer before the MHRA, the Medicines and Healthcare products Regulatory Agency, and helps ensure that products placed on the UK market comply with the applicable regulatory framework. This role is essential for manufacturers that need to register medical devices in Great Britain, maintain technical and regulatory documentation, manage vigilance obligations and respond to MHRA communications.
ALTRION, through its London-based entity, provides full UKRP representation for medical devices and IVDs. The service supports MHRA registration, documentation monitoring, labeling compliance, vigilance coordination and ongoing regulatory communication in line with MHRA requirements.
UKRP appointment and MHRA registration
ALTRION supports the formal appointment of the UK Responsible Person and manages MHRA registration for all device classes, including Class I, IIa, IIb, III and IVDs. This service allows non-UK manufacturers to establish the required regulatory representation for placing devices on the Great Britain market.
The UKRP appointment is a key step for manufacturers without a legal presence in the United Kingdom. ALTRION helps structure the representation process and supports the registration of devices with the MHRA, ensuring that the required information is properly submitted and managed.
Technical documentation and labeling verification
ALTRION verifies technical documentation and labeling compliance to help ensure conformity with UK MDR 2002 and MHRA guidance. This includes reviewing the manufacturer’s technical and regulatory documentation and checking that labeling and Instructions for Use are consistent with the applicable UK requirements.
Correct documentation and labeling are essential for UK market access. ALTRION supports manufacturers by helping keep these materials aligned with the regulatory framework and accessible for MHRA review when required.
MHRA DORS registration management
ALTRION manages registration activities in the MHRA DORS database, the Device Online Registration System. This includes supporting the submission of device information and helping manufacturers obtain proof of device listing in the DORS database.
DORS registration is a practical and important step for UKRP compliance. ALTRION helps manufacturers manage this process in an organized way, reducing uncertainty around registration workflows and supporting clearer communication with the MHRA.
Vigilance coordination and PMS reporting
Post-market compliance is a central part of the UKRP role. ALTRION supports vigilance coordination and Post-Market Surveillance (PMS) reporting, including the submission of serious incident reports and Field Safety Corrective Actions (FSCA) to the MHRA where required.
This service helps manufacturers monitor device performance after market placement and respond properly to safety-related events. By coordinating PMS and vigilance activities, ALTRION supports continued compliance with UK regulatory expectations throughout the product life cycle.
Ongoing liaison with MHRA
ALTRION acts as the official point of contact for regulatory communications and document requests from the MHRA. This ongoing liaison helps non-UK manufacturers manage authority interactions through a London-based representative with knowledge of the UK regulatory framework.
Clear communication with the MHRA is important when questions, document requests, vigilance reports or registration updates arise. ALTRION helps manufacturers maintain responsiveness and continuity in their regulatory communications.
Archiving of technical and regulatory documentation
ALTRION maintains and archives the manufacturer’s technical and regulatory documentation, ensuring accessibility for MHRA review upon request. This includes keeping relevant documentation organized and available so that the manufacturer can demonstrate continued regulatory compliance when needed.
Reliable document maintenance supports both market access and post-market obligations. ALTRION helps manufacturers preserve a clear regulatory record throughout the UKRP relationship.
Annual compliance verification
ALTRION provides annual compliance verification to confirm the continued conformity of devices, labeling and declarations. This activity helps manufacturers monitor whether their documentation and product information remain aligned with UK regulatory expectations over time.
Annual verification is especially useful for manufacturers with multiple devices, changing documentation or evolving market requirements. ALTRION supports this process as part of its ongoing UKRP service.
Optional support for CE to UKCA transition
ALTRION can also provide optional support for the transition from CE marking to UKCA marking, including UDI and labeling updates in anticipation of future MHRA regulatory changes.
This service is designed for manufacturers that need to prepare for evolving UK market access requirements while maintaining control over technical documentation, labeling and regulatory data.
FAQ about UKRP
What is a UKRP?
A UKRP, or UK Responsible Person, is the official representative appointed by a non-UK manufacturer to act before the MHRA for medical devices or IVDs placed on the Great Britain market.
Who needs a UK Responsible Person?
Non-UK manufacturers wishing to place medical devices or in vitro diagnostic devices on the Great Britain market must appoint a UK Responsible Person under UK MDR 2002, as amended.
What does ALTRION do as UKRP?
ALTRION supports UKRP appointment, MHRA registration, DORS registration management, technical documentation verification, labeling compliance, vigilance coordination, PMS reporting and MHRA communication.
What is MHRA DORS?
DORS is the MHRA Device Online Registration System. ALTRION manages registration activities in DORS and supports proof of device listing for manufacturers placing devices on the Great Britain market.
Does UKRP support include post-market compliance?
Yes. ALTRION supports vigilance coordination, PMS reporting, serious incident reports, FSCA submission, annual compliance verification and ongoing MHRA communication.
Why choose ALTRION
ALTRION provides direct legal presence in the UK through its London-based office, giving non-UK manufacturers a reliable local representative for Great Britain market access. Its regulatory team is experienced in UK MDR 2002 compliance and post-Brexit market transition, with a comprehensive understanding of MHRA registration workflows, audits and vigilance protocols. ALTRION also offers integrated coordination with its EU-REP and CH-REP offices for manufacturers operating across multiple jurisdictions. Its contracts are transparent and flexible, typically valid for five years, renewable annually and with no hidden fees. ALTRION is part of a global representation network covering the EU, Switzerland, the UK and the USA.
Deliverables
ALTRION provides the key regulatory outputs required to formalize UKRP appointment, support MHRA registration and maintain ongoing compliance in Great Britain.
- UKRP Service Agreement and Letter of Designation, compliant with Regulation 7A of UK MDR 2002.
- MHRA registration confirmation and proof of device listing in the DORS database.
- Contact details for inclusion on labeling and Instructions for Use (IFU).
- Annual PMS and vigilance summary, including a record of MHRA communications.
- Ongoing support for registration renewals, modifications and compliance updates.
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