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 (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 (Medicines and Healthcare products Regulatory Agency) and ensures that all products placed on the UK market comply with the UK regulatory framework derived from the former EU Directives and updated through post-Brexit legislation.
ALTRION, through its London-based entity, provides full UKRP representation, ensuring that your devices are properly registered with the MHRA, that documentation is continuously monitored, and that vigilance obligationsare fulfilled on time and in line with MHRA requirements.
Our Services
- UKRP appointment and MHRA registration for all device classes (Class I, IIa, IIb, III, and IVDs)
- Verification of technical documentation and labeling compliance, ensuring conformity with the UK MDR 2002 and MHRA guidance
- Registration management in the MHRA DORS database (Device Online Registration System)
- Vigilance coordination and Post-Market Surveillance (PMS) reporting, including submission of serious incident reports and Field Safety Corrective Actions (FSCA) to the MHRA
- Ongoing liaison with MHRA, acting as the official point of contact for regulatory communications and document requests
- Maintenance and archiving of the manufacturer’s technical and regulatory documentation, ensuring accessibility for MHRA review upon request
- Annual compliance verification, confirming continued conformity of devices, labeling, and declarations
- Optional support for transition from CE marking to UKCA marking, including UDI and labeling updates in anticipation of future MHRA regulatory changes
Why Choose ALTRION
- Direct legal presence in the UK, through our London-based office
- Experienced regulatory team specialized in UK MDR 2002 compliance and post-Brexit market transition
- Comprehensive understanding of MHRA registration workflows, audits, and vigilance protocols
- Integrated coordination with our EU-REP and CH-REP offices for manufacturers operating across multiple jurisdictions
- Transparent and flexible contracts, typically valid for five (5) years, renewable annually, with no hidden fees
- Part of ALTRION’s global representation network, covering EU, Switzerland, the UK, and the USA
Deliverables
- 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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