--- title: "UKRP, UK Responsible Person | MedTech Terms" description: "UK-based equivalent of the EU Authorized Representative required for non-UK manufacturers placing devices on the GB market." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ukrp#term", "name": "UK Responsible Person", "alternateName": "UKRP", "description": "The UKRP registers the manufacturer and devices with the MHRA, holds technical documentation, and supports market surveillance. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. UK Responsible Person [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)UKRP # UK Responsible Person UK-based equivalent of the EU Authorized Representative required for non-UK manufacturers placing devices on the GB market. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition The UKRP registers the manufacturer and devices with the MHRA, holds technical documentation, and supports market surveillance. Required for all non-UK manufacturers selling to Great Britain. What the regulation says The UK Medicines and Healthcare products Regulatory Agency (MHRA) Guidance on Submitting registration applications for medical devices specifies the obligations and responsibilities of the UK Responsible Person. These include registering devices with the MHRA, holding technical documentation, and cooperating with the MHRA during market surveillance activities. The UKRP must be a legal person established in the UK. ## What this means in practice UKRP and [EC REP](/terms/ec-rep) are not interchangeable - Brexit created two parallel obligations for any manufacturer selling into both markets. ## Examples - A Canadian MedTech manufacturer appoints a UK-based regulatory consultancy firm to act as its UKRP to manage device registrations with the MHRA. - An Asian MedTech company, having placed CE marked devices on the EU market via an EC REP, must also appoint a separate UKRP to register those same devices for sale in England, Scotland, and Wales. - During a post-market surveillance inquiry, the MHRA contacts the UKRP of a US-based manufacturer to request specific technical documentation related to a reported adverse event. Common pitfalls - • A common pitfall is the failure to properly define the contractual agreement between the manufacturer and the UKRP, leading to misunderstandings regarding responsibilities and liabilities. - • Manufacturers may mistakenly believe that their EU-based Authorized Representative can also act as their UKRP, leading to non-compliance for the Great Britain market. - • Inadequate access to the manufacturer’s technical documentation by the UKRP can hinder their ability to respond effectively to MHRA requests, resulting in regulatory delays or enforcement actions. - • Neglecting to keep the UKRP informed of significant changes to devices or quality management systems can invalidate registrations and lead to non-compliance. - • Choosing a UKRP without sufficient regulatory expertise can lead to errors in device registration and ongoing compliance. ## Frequently asked questions What is the primary role of a UK Responsible Person? The primary role of a UK Responsible Person (UKRP) is to act as a point of contact in the UK for manufacturers not based in the UK, ensuring their medical devices comply with UK regulations and are properly registered with the MHRA. Is a UKRP required for all medical devices sold in Great Britain? What documentation must the UKRP hold? Can the manufacturer appoint any legal person as a UKRP? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Authorized Representative (EU)(EC REP) Legal entity established in the EU that represents a non-EU manufacturer for MDR/IVDR purposes. ](/terms/ec-rep)[ Regulatory MHRA / UKCA Marking(MHRA / UKCA) UK regulator and post-Brexit conformity marking for medical devices in Great Britain. ](/terms/mhra-ukca) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory 510(k) Summary vs 510(k) Statement Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 MHRA· 1 FDA· 1 European Commission· 1 1. [1 MHRA UKRP Guidance Verified MHRA · gov.uk ](https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk) 2. [2 FDA - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices) 3. [3 European Commission - Medical Devices Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym UKRP Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=ukrp) Learn in 60 seconds Card Lesson Quiz UK-based equivalent of the EU Authorized Representative required for non-UK manufacturers placing devices on the GB market. - · UKRP and EC REP are not interchangeable - Brexit created two parallel obligations for any manufacturer selling into both markets. - · Required for all non-UK manufacturers selling to Great Britain. Remember this Watch out: A common pitfall is the failure to properly define the contractual agreement between the manufacturer and the UKRP, leading to misunderstandings regarding responsibilities and liabilities. Related terms - [MHRA / UKCA Marking(MHRA / UKCA) ](/terms/mhra-ukca) - [Authorized Representative (EU)(EC REP) ](/terms/ec-rep) You may also need Auto-suggested from Regulatory and shared keywords. - [Person Responsible for Regulatory Compliance(PRRC) ](/terms/prrc) - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) - [CE Mark ](/terms/ce-mark) - [IVDR Conformity Assessment Routes ](/terms/ivdr-conformity-assessment-routes) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [Swissmedic ](/terms/swissmedic) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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