UKRP Responsible Person in the United Kingdom for Medical Devices

Accessing the Great Britain Market

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), ensuring that all products comply with the UK regulatory framework derived from former EU Directives and updated through post-Brexit legislation.

ALTRION, through its London-based entity, provides full UKRP representation, ensuring proper MHRA registration, continuous documentation oversight, and timely fulfillment of vigilance obligations in line with MHRA requirements.

Our Services

UKRP Appointment & Registration

• UKRP appointment and MHRA registration for all device classes (Class I, IIa, IIb, III, and IVDs)

Documentation & Compliance

• Verification of technical documentation and labeling
• Ensuring conformity with UK MDR 2002 and MHRA guidance

MHRA Registration Management

• Management of device registration in the MHRA DORS database (Device Online Registration System)

Post-Market Activities

• Vigilance coordination and Post-Market Surveillance (PMS) reporting
• Submission of serious incident reports and Field Safety Corrective Actions (FSCA)

Regulatory Communication

• Ongoing liaison with MHRA as the official point of contact
• Management of regulatory communications and document requests

Documentation Management

• Maintenance and archiving of technical and regulatory documentation
• Ensuring availability for MHRA review upon request

Compliance Monitoring

• Annual compliance verification of devices, labeling, and declarations

UKCA Transition Support (Optional)

• Support for transition from CE marking to UKCA marking
• UDI and labeling updates aligned with future MHRA regulatory changes

Our Approach

We act as a reliable UK-based regulatory partner, ensuring full compliance, transparency, and continuity throughout the entire product lifecycle, from initial registration to ongoing market surveillance.