UK Responsible Person (UKRP) Services
Official in-country representation for non-UK medical device and IVD manufacturers. Managing MHRA product registrations, technical documentation custody, post-market vigilance, and UK market compliance.
The Legal Role of the UK Responsible Person
The statutory position of a UK Responsible Person (UKRP) was formally established under the UK Medical Devices Regulations 2002 (UK MDR 2002), as amended by the UK MDR 2019 following the United Kingdom’s departure from the European Union.
Statutory Definition under UK MDR:
"A person established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer’s obligations under the regulations."
Under UK legislation, only a manufacturer or a designated UK Responsible Person can legally place a medical device or IVD on the Great Britain (England, Wales, and Scotland) market. Non-UK manufacturers must appoint a UKRP before their products can be commercialized in the region. Furthermore, a single manufacturer is legally permitted to have several designated UK Responsible Persons across different device portfolios.
Designation Mandate & Contract
Documentary evidence in the form of a formal contract or signed Letter of Designation on official company letterhead must be established between the overseas manufacturer and the UKRP.
Grace Periods for UKRP Appointment & MHRA Registration
The statutory requirement for an overseas manufacturer to have a UK Responsible Person in place aligns with the MHRA device registration grace periods.
Strategic Early Appointment
While grace periods govern initial MHRA registrations, manufacturers are strongly advised to appoint a UK Responsible Person well in advance of commercial deployment. Drawing up a comprehensive bilateral mandate, verifying technical files, and establishing post-market surveillance protocols requires dedicated onboarding time.
Immediate Post-Market Surveillance (PMS)
Appointing your UKRP early ensures immediate post-market vigilance coverage for devices already distributed in Great Britain, guaranteeing that adverse event escalations and user complaints are managed seamlessly in full coordination with the MHRA.
Key Responsibilities of the UK Responsible Person
As set out in Part II (r. 7A), Part III (r. 21A), Part IV (r. 33A), Regulation 77 (Medical Devices), and Regulation 146 (IVDs) of the UK MDR 2002 (as amended by UK MDR 2019), the UK Responsible Person must execute the following duties:
Declaration of Conformity & Technical Files
Ensure that the Declaration of Conformity and technical documentation have been properly drawn up, and that appropriate conformity assessment procedures have been completed by the manufacturer.
Document Custody for MHRA Inspection
Maintain readily available copies of technical documentation, Declaration of Conformity, and relevant UKCA/CE certificates (including amendments and supplements) for MHRA inspection upon request.
Information Disclosure to MHRA
Provide the MHRA with all necessary information and documentation required to demonstrate the conformity of the device in response to any official statutory request.
Sample & Device Access Forwarding
Forward to the manufacturer any request by the MHRA for physical samples or access to a device, and ensure the MHRA receives the samples or is granted facility access.
Corrective Action & Safety Cooperation
Cooperate actively with the MHRA on any preventive or corrective action taken to eliminate or mitigate risks posed by devices placed on the UK market.
Immediate Vigilance & Complaint Relaying
Immediately inform the overseas manufacturer about complaints and reports from UK healthcare professionals, patients, and users regarding suspected incidents or device malfunctions.
Mandatory Relationship Termination Clause
The UKRP must terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under UK MDR regulations, and formally inform the MHRA and the relevant Approved Body of that termination.
Additional Responsibilities: Registration & Vigilance
Registration Responsibilities
The UK Responsible Person must carry out specified tasks in relation to the manufacturer’s obligations. This includes registering with the MHRA before the device is placed on the UK market. The UKRP opens and maintains a single registration account on behalf of all the manufacturers it represents.
Post-Market Surveillance (PMS) Duties
The UKRP is required to fulfill statutory incident reporting requirements under regulation 7A (Medical Devices), regulation 21A (Active Implantable Medical Devices - AIMD), and regulation 33A (IVDs). The bilateral mandate should clearly delineate whether any joint post-market surveillance tasks are delegated, while the manufacturer remains ultimately responsible for fulfilling all obligations.
Location, Qualifications & Legal Liability
Physical UK Location
A UK Responsible Person must possess a registered place of business in the United Kingdom at which service of any legal document relating to placing the device on the market is effective. This address is used for all official MHRA communications.
Qualifications & Competency
While specific academic credentials are not mandated, the UK Responsible Person must possess the technical competency and regulatory capability to carry out all statutory obligations defined under UK MDR 2002.
Regulation 60 Liability
Under Regulation 60 and the Consumer Protection Act 1987, a UKRP can be proceeded against as a person placing the device on the market. Manufacturers and UKRPs typically structure mandates with appropriate indemnity and product liability insurance coverage.
Request UK Responsible Person Representation
Appoint NKB Regovanta as your official UKRP. We handle MHRA registrations, technical dossier storage, and regulatory communications.