Best UK Responsible Person (UKRP) | Compare & Get Quotes

Q: What is a UK Responsible Person (UKRP)?

A UK Responsible Person (also called UKRP or MHRA responsible person ) is a legal entity established in the UK that acts on behalf of non-UK manufacturers to fulfill regulatory obligations for placing medical devices and IVD on the Great Britain market under UK Medical Devices Regulations 2002 [1] . The UKRP serves as the manufacturer's representative and is responsible for ensuring devices comply with UK medical device regulations [1] . Key responsibilities include: verifying the manufacturer has appropriate technical documentation and quality management systems [1] , keeping technical documentation available for UK authorities (MHRA) [1] , cooperating with MHRA on corrective actions and field safety notices [1] , informing MHRA of device incidents and field safety corrective actions [1] , and acting as a contact point between the manufacturer and UK authorities [1] . The UK Responsible Person must be established in the UK [1] and cannot be the same entity as the importer or distributor for the same device [1] .

Q: Is UKRP required for IVD as well?

Yes, UK Responsible Person requirements apply to both medical devices and in vitro diagnostic devices (IVD) placed on the Great Britain market [1] . After Brexit, the UK implemented its own regulatory framework (UK MDR 2002 as amended) [1] , which requires non-UK manufacturers of both medical devices and IVD to appoint a UKRP [1] . Many UKRP services providers support both medical devices and IVD, though some may specialize in one or the other. When evaluating UK Responsible Person providers, confirm their experience with your specific device types (medical devices vs. IVD) and classifications, as IVD has distinct regulatory requirements and classification rules under UK regulations [1] .

Q: What impacts UKRP pricing?

UK Responsible Person pricing (also called UKRP cost or UKRP pricing ) varies based on several factors: device classification (Class I, IIa, IIb, III [1] , or IVD classes—higher risk classes typically cost more), portfolio size (number of devices and device families), service scope (basic UKRP representation vs. full regulatory support including vigilance, PMS, etc. [1] ), surveillance needs (post-market surveillance, periodic safety update reports [1] ), change management (frequency of device changes requiring notifications to MHRA), and contract terms (annual retainer vs. per-device fees). Some UK Responsible Person providers also charge setup fees, renewal fees, or fees for specific services like vigilance handling or MHRA registration support. Request detailed UKRP pricing breakdowns to compare effectively.

Q: What should I prepare when onboarding with a UKRP?

To streamline UK Responsible Person onboarding, prepare: device information (device names, GMDN codes, UDI-DI codes, classifications [1] ), technical documentation overview (summary of technical files, not full files initially) [1] , conformity assessment route (notified body certificates, self-declaration paths) [1] , existing registrations (if devices were previously on market under EU regulations), labeling and IFU samples (UKCA marking requirements [1] ), quality management system certificate (ISO 13485 [2] ), and manufacturer details (company information, manufacturing sites). Some UKRP providers may also request a device portfolio list, risk management files summary, and clinical evaluation summaries. The exact requirements vary by UK Responsible Person provider and device complexity, but having these documents ready can significantly speed up the onboarding process, typically 2-6 weeks.

Q: Can the same provider cover UKRP and EU AR?

Yes, many providers offer both UK Responsible Person and EU Authorized Representative (EC REP) services, which can be convenient for manufacturers selling in both Great Britain and the EU. However, these are separate regulatory roles with distinct requirements [1] [2] : UKRP is for the UK market (Great Britain) [1] , while EC REP is for the EU market [2] . When evaluating providers offering both UKRP services and EU AR services, confirm: their UK establishment location (for UKRP [1] ) and EU establishment location (for EC REP [2] ), whether they can handle both roles under a single contract or require separate agreements, their experience with both UK and EU regulatory frameworks, and their ability to coordinate between UK and EU authorities when needed. Some manufacturers prefer separate providers to avoid potential conflicts, while others value the convenience of a single UK Responsible Person and EU AR provider.

Q: What is the difference between UKRP and EU Authorized Representative?

UKRP (UK Responsible Person) [1] and EU Authorized Representative (EC REP) [2] are similar roles but serve different markets. UKRP is required for non-UK manufacturers placing devices on the Great Britain market under UK medical device regulations [1] . EC REP is required for non-EU manufacturers placing devices on the EU market under EU MDR/IVDR [2] . While the roles are similar (both act as regulatory representatives, maintain technical documentation access, handle authority communications, and support vigilance), they operate under different regulatory frameworks [1] [2] . After Brexit, the UK has its own medical device regulations [1] , so manufacturers selling in both markets typically need both a UK Responsible Person and an EC REP. Some providers offer both UKRP services and EU AR services, but they require separate establishments (UK for UKRP , EU for EC REP) and may have different contract terms.

Q: How quickly can I get UKRP services set up?

UK Responsible Person setup timelines vary by provider and your readiness. Simple setups with complete documentation can take 2-4 weeks, while more complex portfolios may take 4-8 weeks. Factors affecting timeline include: completeness of your documentation, UKRP provider's processing speed and MHRA relationship, device complexity and classification [1] , whether you need MHRA registration support, and any language or translation requirements. Many UK Responsible Person providers offer expedited services for urgent cases, though this typically incurs additional fees. Once the UKRP is appointed and registered with MHRA [1] , you can usually start placing devices on the Great Britain market, though you'll need to ensure all other UK requirements (like UKCA marking [1] ) are met.

Q: Can an importer or distributor act as my UKRP?

Many manufacturers choose an independent UK Responsible Person to avoid conflicts of interest. UKRP and importer/distributor roles have different obligations [1] , and combining roles can create commercial and operational conflicts [1] . The UKRP must be established in the UK and cannot be the same entity as your importer or distributor for the same device [1] . Confirm role compatibility and contract scope with the UK Responsible Person provider.

Q: Does a UKRP handle MHRA device registrations for me?

Some UK Responsible Person providers offer MHRA registration support [1] , but it's not universal. If you need help with account setup, registrations, updates, and change handling [1] , confirm the exact deliverables, SLAs, and UKRP pricing model with the provider. UKRP services may include MHRA registration assistance as an additional service.

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Compare Best UK Responsible Person (UKRP) | Compare & Get Quotes Providers

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Euverify Pro

Euverify provides automated compliance tools and GDPR Representative services to help businesses meet EU/UKCA regulations. Streamline your compliance journey with expert guidance.

Euverify offers a comprehensive platform designed to simplify your compliance journey. Their services include automated compliance tools for EU/UKCA regulations, helping you generate necessary declarations and understand complex requirements. They also provide a GDPR Representative Module, assisting businesses in meeting their obligations under GDPR. The Euverify Help Center offers step-by-step guides, feature explanations, and answers to common compliance questions, ensuring you can efficiently manage your account, appoint authorized representatives, and keep your products legally compliant. Whether you are new to compliance or switching systems, Euverify aims to make the process seamless and efficient.

Website: euverify.com

HQ: London, GB

Jurisdictions: EU, UK

Countries: Germany, France, Austria, Belgium, Denmark, Italy, Netherlands, Poland, Spain, Sweden, UK

Languages: English

Response SLA: 24 hours

Onboarding time: 1 days

Pricing model: Retainer

Starting from: GBP 32

Device Classes: Class I, Class IIa, Class IIb

GB Coverage: Yes

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Emergo by UL

Emergo by UL offers comprehensive medical device regulatory consulting, including market access, human factors, privacy, and device registration services globally.

Emergo by UL provides expert regulatory consulting for the healthcare industry, specializing in medical device and IVD compliance. Their services cover the entire product lifecycle, from initial design and human factors research to market access, privacy and security, and post-market surveillance. Leveraging extensive global expertise, Emergo by UL assists manufacturers in navigating complex regulations for international market entry. They offer specialized services such as in-country representation, device registration, and regulatory intelligence. Their digital platform and tools aim to simplify and automate regulatory affairs and quality assurance activities. Key service areas include Market Access, Human Factors Research & Design, Privacy & Security Services, Product Classification, and Device Registration. Emergo by UL is dedicated to helping clients evolve with the changing healthcare landscape and achieve global compliance.

Website: emergobyul.com

HQ: Cambridge, US

Jurisdictions: UK

Countries: GB

Languages: English

Response SLA: 24 hours

Onboarding time: 3–21 days

Pricing model: Retainer

Starting from: GBP 6,500

Device Classes: IVD

GB Coverage: Yes

Services: Vigilance

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OMC Medical (UKRP)

OMC Medical offers expert regulatory support for medical devices and IVDs, specializing in UK Responsible Person services, product registration, and compliance. They assist manufacturers globally in navigating complex regulatory landscapes.

OMC Medical is a UK-based provider of comprehensive regulatory support for medical devices and IVDs, with a global reach. They specialize in assisting manufacturers, particularly those based outside the UK, in meeting the requirements for placing devices on the Great Britain market, including the appointment of a UK Responsible Person. Their services encompass product registration, classification, technical documentation, quality assurance, and post-market surveillance. OMC Medical also provides guidance on cosmetic and food supplement regulations, as well as translation services to ensure compliance across different regions. With a focus on navigating the evolving regulatory environment, including MHRA guidance for software medical devices and apps, OMC Medical acts as a trusted partner to help clients successfully launch and maintain their products in the global market. They offer free consultations to address specific queries and guide clients through the regulatory process.

Website: ukrp.omcmedical.com

HQ: Bristol, UK

Jurisdictions: UK

Countries: GB

Languages: English

Response SLA: 24 hours

Onboarding time: 3–21 days

Pricing model: Onboarding + annual retainer

Starting from: GBP 3,500

Device Classes: IVD

GB Coverage: Yes

Services: Vigilance

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Advena (UK Responsible Person)

The UK Responsible Person Association (UKRPA) is an alliance of UK Responsible Persons, promoting professional conduct and competence in the medical device industry. They cooperate with the MHRA to enhance regulatory understanding.

The UK Responsible Person Association (UKRPA) was established in December 2020 as an alliance of providers of services as UK Responsible Persons, as defined in the Medical Devices Regulations 2002. The association's primary goal is to promote professional conduct and competence among companies and individuals performing this critical role. Recognizing that there are no specific qualification requirements for a UK Responsible Person, UKRPA emphasizes the need for a strong understanding of regulatory requirements for medical devices and commensurate experience. Founding members of UKRPA are companies specializing in regulatory services for medical device manufacturers, bringing extensive experience akin to the UKRP role. The association is open to all who act as a UKRP, fostering a spirit of professionalism and excellence. They actively cooperate with the Medicines and Healthcare products Regulatory Agency (MHRA) to improve transparency and understanding of the regulatory landscape. For those seeking a professional UK Responsible Person, the UKRPA directs inquiries to their Members page for contact details. General inquiries and membership applications can be directed via email.

Website: advenamedical.com

HQ: Warwick, UK

Jurisdictions: UK

Countries: GB

Languages: English

Response SLA: 24 hours

Onboarding time: 3–21 days

Pricing model: Retainer

Starting from: GBP 5,000

GB Coverage: Yes

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Qarad (UK Responsible Person)

The UK Responsible Person Association (UKRPA) is an alliance of providers of UK Responsible Person services, promoting professional conduct and competence among its members.

The UK Responsible Person Association (UKRPA) was established in December 2020 as an alliance for companies and individuals acting as UK Responsible Persons under the Medical Devices Regulations 2002. The association's primary goal is to promote professional conduct and competence within the field. While the regulations do not specify qualifications, the responsibilities of a UKRP necessitate a strong understanding of medical device regulatory requirements and relevant experience. UKRPA comprises founding members who are specialists in providing regulatory services to medical device manufacturers globally, bringing extensive experience akin to the UKRP role. The association welcomes all companies and individuals serving as UKRPs, aiming to foster professionalism and excellence. They actively cooperate with the MHRA to improve transparency and understanding of regulatory requirements. For those seeking a professional UK Responsible Person, the association's Members page provides contact details. General inquiries and membership applications can be directed to enquiries@ukrp-association.org.

Website: qarad.com

HQ: Birmingham, UK

Jurisdictions: UK

Countries: GB

Languages: English

Response SLA: 24 hours

Onboarding time: 3–21 days

Pricing model: Retainer

Starting from: GBP 4,000

GB Coverage: Yes

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QbD Group (UKRP)

QbD Group is a strategic partner in Life Sciences, accelerating innovation and ensuring regulatory compliance for pharma, MedTech, and IVD companies. They offer full-life cycle support from idea to patient.

QbD Group is a strategic partner in Life Sciences, dedicated to accelerating innovation and ensuring confident growth through regulatory compliance and operational excellence. They support over 1,200 start-ups, scale-ups, and global leaders across pharma, MedTech, and IVD sectors, solving complex challenges in quality, regulatory, clinical, and digital domains. With a team of over 600 professionals, QbD Group provides tailored, cost-effective solutions, including regulatory affairs, quality assurance, lab services, qualification & validation, clinical solutions, and software services. They help companies enter and thrive in the European market with strong GxP know-how, regulatory strategy, and clinical evidence expertise. Their approach emphasizes agile collaboration, proactive problem-solving, and delivering high-quality results efficiently. QbD Group embeds into client teams with flexibility and transparency, fostering shared success and building long-term partnerships. They offer comprehensive lifecycle support, global reach with local expertise, and a proven track record of successful projects.

Website: qbdgroup.com

HQ: London, UK

Jurisdictions: UK

Countries: GB

Languages: English

Response SLA: 48 hours

Onboarding time: 3–21 days

Pricing model: Custom pricing

Starting from: GBP 6,000

Device Classes: IVD

GB Coverage: Yes

Services: Vigilance

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MDSS (UK Responsible Person)

MDSS provides expert UK Responsible Person (UKRP) services for medical device and IVD manufacturers outside the UK, ensuring compliance with MHRA regulations for market access.

MDSS acts as your dedicated UK Responsible Person (UKRP), a crucial role for medical device and IVD manufacturers located outside the UK who wish to place their products on the UK market. We ensure your compliance with the Medical Devices Regulations 2002 and guide you through the necessary MHRA registration processes (PARD). With over 30 years of experience in regulatory affairs, MDSS offers comprehensive in-country representation services across the EU, UK, Switzerland, USA, and Australia. Our expertise extends to navigating complex regulatory landscapes, including the AI Act and General Product Safety Regulation (GPSR) in the EU. We are committed to facilitating your market access by managing regulatory requirements, allowing you to concentrate on innovation and your core business. MDSS stays abreast of regulatory changes, such as the MHRA's consultations on future UK medical device regulations and international recognition frameworks.

Website: mdss.com

HQ: London, UK

Jurisdictions: UK

Countries: GB

Languages: English

Response SLA: 48 hours

Onboarding time: 3–21 days

Pricing model: Onboarding + annual retainer

Starting from: GBP 5,500

GB Coverage: Yes

Services: Vigilance

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CMC Medical Devices (UKRP)

CMC Medical Devices offers expert regulatory consulting and in-country representation for medical devices in the UK and globally. They ensure compliance and market access for manufacturers.

CMC Medical Devices (UKRP) is a specialized consultancy firm focused on regulatory affairs for medical devices, offering comprehensive services for international market access. Based in Spain, the company has established a significant presence with offices in the UK, Switzerland, USA, Australia, and China, enabling them to provide personalized regulatory solutions across diverse global markets. Their core offerings include in-country representation, such as UK Responsible Person (UKRP) services, European Authorized Representative (EC REP) services, and Swiss Authorized Representative (CH REP) services. These services are crucial for manufacturers outside these regions seeking to comply with local regulations and ensure their products can legally circulate in these markets. Beyond representation, CMC Medical Devices provides extensive consulting on regulatory compliance, including MDR, IVDR, ISO 13485, and EUDAMED registration. They assist with technical file preparation, quality management system establishment, and Free Sale Certificates, acting as a primary point of contact with local authorities to facilitate smooth communication and continuous compliance. Their expertise ensures that medical device manufacturers can navigate complex regulatory landscapes efficiently and successfully launch their products.

Website: cmcmedicaldevices.com

HQ: Spain, ES

Jurisdictions: UK

Countries: GB

Languages: English

Response SLA: 72 hours

Onboarding time: 3–21 days

Pricing model: Retainer

Starting from: EUR 3,200

Device Classes: Class I, Class IIa, Class IIb

GB Coverage: Yes

Services: Vigilance

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8foldGovernance (UKRP)

8foldGovernance offers expert governance, risk, and compliance solutions for UK regulated entities. They provide tailored advisory services to navigate complex regulatory landscapes.

8foldGovernance is a specialist consultancy focused on providing comprehensive governance, risk, and compliance (GRC) services. They cater to regulated entities within the UK, offering tailored solutions to meet specific industry and regulatory requirements. Their expertise spans across various aspects of GRC, ensuring that clients can operate effectively and compliantly within the UK's stringent regulatory framework. With a commitment to delivering practical and actionable advice, 8foldGovernance helps organizations to identify and mitigate risks, strengthen their internal controls, and enhance their overall governance structures. They work closely with clients to understand their unique challenges and develop customized strategies that align with business objectives and regulatory obligations. Their services are designed to build trust and ensure long-term sustainability for their clients in the UK market.

Website: 8foldgovernance.com

HQ: Brighton, UK

Jurisdictions: UK

Countries: GB

Languages: English

Response SLA: 48 hours

Onboarding time: 3–21 days

Pricing model: Per project

Starting from: GBP 1,500

Device Classes: Class I, Class IIa, Class IIb

GB Coverage: Yes

Services: Vigilance

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Freyr (UKRP Services)

Freyr is a leading global regulatory solutions provider for life sciences firms, specializing in facilitating market entry and product registrations in Japan through PMDA. They offer comprehensive services including regulatory strategy, market intelligence, and post-market surveillance.

Freyr is a premier regulatory solutions provider dedicated to supporting life sciences companies across the entire regulatory spectrum. With a significant global presence in over 120 countries, Freyr excels at enabling successful market entry, particularly in Japan, for pharmaceutical and life sciences companies. Freyr Japan is instrumental in assisting companies with product registrations under the Pharmaceuticals and Medical Devices Agency (PMDA). Their expertise covers a wide range of services, including the formulation of regulatory strategies, market intelligence gathering, in-country representation, and post-market surveillance. They also provide advanced regulatory software solutions designed to optimize the PMDA registration process. Freyr Life Sciences K.K., the Japanese subsidiary, is staffed by seasoned experts deeply familiar with Japan's regulatory landscape and pharmaceutical affairs. Leveraging an extensive international network, Freyr offers seamless support for product introductions into various overseas markets and develops tailored market entry strategies for Japan. Their team collaborates with leading manufacturers of medical devices, pharmaceuticals, OTC medicines, and cosmetics to ensure swift product approvals and timely market access. With a commitment to delivering the latest life sciences innovations worldwide, Freyr's robust global network, spanning over 25 countries, empowers them to offer end-to-end market approval support. This includes services for domestic Japanese manufacturers and assistance for entering international markets, making them a comprehensive partner for regulatory success.

Website: ukrpservices.com

HQ: London, JP

Jurisdictions: UK

Countries: GB

Languages: English

Response SLA: 24 hours

Onboarding time: 3–21 days

Pricing model: Custom pricing

Starting from: GBP 4,500

GB Coverage: No

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i3CGlobal (UKRP)

i3CGlobal is a trusted regulatory consulting company specializing in medical device compliance for the UK and EU markets. They offer expert services for MHRA registration, UK Responsible Person (UKRP) appointments, and CE marking under MDR and IVDR.

i3CGlobal provides world-class regulatory consulting services for medical device manufacturers seeking to place their products on the UK and EU markets. As a trusted partner, they offer comprehensive support for navigating complex regulatory landscapes, including MHRA registration and acting as the UK Responsible Person (UKRP) for post-Brexit compliance. Their expertise covers essential services such as MDR and IVDR technical file preparation, clinical evaluation reports, risk management, and CE marking. i3CGlobal is committed to ensuring your devices meet all applicable laws and guidelines, offering a reliable and efficient pathway to market access. They also provide support for UKCA technical documentation and ISO 13485 implementation. With a focus on data security, certified by ISO 27001, and operating 24/7, i3CGlobal ensures the confidentiality and integrity of your information while delivering services promptly. They are dedicated to providing fair pricing and on-time delivery, making them a go-to choice for manufacturers worldwide.

Website: i3cglobal.com

HQ: London, UK

Jurisdictions: UK

Countries: GB

Languages: English

Response SLA: 48 hours

Onboarding time: 3–21 days

Pricing model: Per project

Starting from: GBP 1,200

Device Classes: Class I, Class IIa, Class IIb

GB Coverage: Yes

Services: Vigilance

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Pure Global (UKRP)

Pure Global offers AI-powered medical device regulatory consulting and market access services in over 30 markets. They provide streamlined registration, local representation, and post-market support with transparent, flat-fee pricing starting at $2,000 USD per year.

Pure Global specializes in accelerating market entry for MedTech companies through AI-driven regulatory solutions and global representation. With over 15 offices across five continents, they offer comprehensive services including dossier compilation, in-country representation, translation, modifications, distributor authorization, and post-market support. Their services are designed to navigate complex regulatory landscapes, ensuring compliance and efficient product registration in over 30 markets. Pure Global leverages AI and data tools to provide regulatory intelligence, monitor changes, and streamline compliance journeys. They offer a flat annual fee structure, starting at $2,000 USD per year for the first device, which covers a range of essential services. Key offerings include regulatory strategy, market research, classification and grouping, submission and registration, and post-market surveillance. Pure Global aims to minimize risks, reduce costs, and expedite the process of bringing medical devices to target markets worldwide.

Website: pureglobal.com

HQ: Boston, UK

Jurisdictions: UK

Countries: GB

Languages: English

Response SLA: 48 hours

Onboarding time: 3–21 days

Pricing model: Custom pricing

Starting from: USD 7,000

Device Classes: Class I, Class IIa, Class IIb

GB Coverage: Yes

Services: Vigilance

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IMed Consultancy (UKRP)

IMed Consultancy offers expert UKRP services for medical devices and IVDs, ensuring compliance with UK regulations post-Brexit. They provide direct access to UK-based QA/RA experts for market entry.

IMed Consultancy specializes in UKRP (UK Responsible Person) services, guiding medical device and IVD manufacturers through the complexities of the UK market. Following Brexit, European regulations no longer apply, and IMed Consultancy ensures your products meet the specific UK requirements, including demonstrating compliance with UK MDR 2002 and managing MHRA registrations. Benefit from direct access to a dedicated team of UK-based QA/RA experts who provide strategic guidance and support for your market entry. IMed Consultancy acts on your behalf, offering a qualified and experienced UKRP to navigate regulatory changes and protect your market position. They are equipped to support global manufacturers with their regulatory and compliance needs within the UK.

Website: imedconsultancy.com

HQ: Banbury, UK

Jurisdictions: UK

Countries: GB

Languages: English

Response SLA: 72 hours

Onboarding time: 3–21 days

Pricing model: Per project

Starting from: GBP 1,400

Device Classes: IVD

GB Coverage: Yes

Services: Vigilance

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TS Quality & Engineering (UKRP)

Freyr is a leading global regulatory solutions and services provider, specializing in AI-first platforms and end-to-end regulatory lifecycle management for the pharmaceutical and life sciences industries.

Freyr is a premier global regulatory solutions and services provider with a strong presence in the UKRP (United Kingdom and Republic of Ireland) market. They offer an AI-first regulatory platform, 'freya fusion', designed to manage the entire regulatory lifecycle, from submissions and labeling to intelligence and change control. With over 15 years of expertise, Freyr empowers companies to navigate complex compliance needs and achieve regulatory excellence. Their services cater to a wide range of needs, including market access, drug development, regulatory strategy, dossier authoring, post-approval management, and country-specific regulatory affairs. Freyr is recognized for its ability to deliver tailored solutions, such as staff augmentation and custom technology integrations, to accelerate regulatory operations and transform compliance into success for global bio-pharmaceutical giants and other life sciences innovators. Freyr's commitment to innovation is evident in their AI chatbot for instant regulatory answers and their strategic global presence, ensuring they are a reliable partner for businesses seeking to bring products to market compliantly and efficiently.

Website: tsquality.ch

HQ: London, GB

Jurisdictions: UK

Countries: GB

Languages: English

Response SLA: 48 hours

Onboarding time: 3–21 days

Pricing model: Per project

Starting from: EUR 1,800

Device Classes: IVD

GB Coverage: Yes

Services: Vigilance

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UKRepMed (UKRP)

UKRepMed provides expert UK Responsible Person (UKRP) services for medical devices, food supplements, cosmetics, and electronics, ensuring seamless market entry and regulatory compliance for global brands.

UKRepMed Ltd is a leading UK Responsible Person service provider, dedicated to facilitating market access for global brands. We specialize in ensuring compliance with UK regulations for a wide range of products, including medical devices, food supplements, cosmetics, and electronics and consumer goods. Our mission is to make UK market entry smooth, cost-effective, and stress-free. We act as your legal representative, offering integrity, efficiency, and full regulatory compliance. For medical device manufacturers outside the UK, we serve as the mandatory UK Responsible Person (UKRP), managing MHRA registration and post-market surveillance. For food supplements, we act as the UK Food Business Operator (FBO), ensuring product safety, traceability, and compliance with UK food law. We also provide comprehensive UKRP services for the cosmetics industry, assessing formulations, managing Product Information Files (PIF), and handling notifications to the SCPN portal. For electronics and consumer goods, we act as the primary contact for UK regulatory authorities, assisting with WEEE and RoHS compliance, technical documentation, and marketplace onboarding. With extensive expertise in UK regulations and a commitment to dedicated support, UKRepMed ensures your products meet all necessary requirements, allowing you to sell in the UK with confidence.

Website: ukrepmed.com

HQ: Coxbridge, United Kingdom

Jurisdictions: UK

Countries: GB

Languages: English

Response SLA: 48 hours

Onboarding time: 3–21 days

Pricing model: Retainer

Starting from: GBP 2,500

Device Classes: Class I, Class IIa, Class IIb

GB Coverage: Yes

Services: Vigilance

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Thema Med (UK Responsible Person)

Thema Med is a UK Responsible Person service provider, offering expert regulatory consultancy for medical devices and IVDs. They ensure compliance and market access in the UK and internationally.

Thema Med specializes in providing UK Responsible Person (UK RP) services, ensuring that medical devices and In Vitro Diagnostic (IVD) devices comply with UK regulations for market access. As a leading medical regulatory consultancy, Thema Med offers strategic regulatory consulting to manufacturers and distributors, guiding them through complex changes and necessary transformations to operate successfully in the medical device field. Their services extend beyond the UK, encompassing support for CE marking, Italian and European ministerial registrations, and international registrations outside the EU. Thema Med also provides expertise in Quality and international GMPs, training, and events. They are dedicated to helping clients achieve their sales objectives through reliable and competent regulatory partnerships, ensuring products are safe, effective, and compliant. With a mission to save lives and preserve health, Thema Med aims to be a key part of a system focused on disseminating information and training in the medical field. They strive to enable global access to adequate treatments and products, making a significant and lasting impact in their operational sectors. Their experienced staff collaborates with clients, learners, and beneficiaries to find the best solutions and protect interests.

Website: thema-med.com

HQ: Imola, IT

Jurisdictions: UK

Countries: GB

Languages: English

Response SLA: 24 hours

Onboarding time: 3–21 days

Pricing model: Custom pricing

Starting from: EUR 3,500

Device Classes: Class I, Class IIa, Class IIb

GB Coverage: Yes

Services: Vigilance

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Casus Consulting (UKRP)

Casus Consulting offers expert guidance for medical device market access in Europe, the UK, and Switzerland, specializing in regulatory compliance and registration.

Casus Consulting provides comprehensive support for navigating the complex regulatory landscapes of Europe, the UK, and Switzerland. They assist businesses with essential steps to market, including EU Authorized Representation, MDR and IVDR CE Marking, UK Responsible Person services, MHRA Device Registration, and UKCA Marking. Their expertise ensures smooth market entry and compliance for medical devices in these key regions.

Website: casusconsulting.com

HQ: London, UK

Jurisdictions: UK

Countries: GB

Languages: English

Response SLA: 48 hours

Onboarding time: 3–21 days

Pricing model: Per project

Starting from: GBP 1,600

GB Coverage: Yes

Services: Vigilance

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Pathaway Services Ltd (UKRP)

Pathaway Services Ltd is a UK-based provider of UK Responsible Person (UKRP) services for In Vitro Diagnostic (IVD) manufacturers. They ensure compliance with MHRA regulations for devices placed on the UK market.

Pathaway Services Ltd offers crucial UK Responsible Person (UKRP) services, essential for manufacturers of In Vitro Diagnostic (IVD) and Medical Devices who do not have an establishment within the UK. As mandated by the MHRA since January 1st, 2021, the UKRP acts as the local representative responsible for placing devices on the UK market. This role is vital for ensuring regulatory compliance, acting as a primary point of contact for the MHRA and UK customers, and sharing liability for the devices. Pathaway Services Ltd provides this critical support, ensuring that non-UK based manufacturers can effectively navigate the UK's regulatory landscape and maintain the safety and effectiveness of their products in the market. Their services are particularly important for companies seeking to access the UK market following Brexit, mirroring the established role of an EU Authorised Representative.

Website: pathaway.co.uk

HQ: London, UK

Jurisdictions: UK

Countries: GB

Languages: English

Response SLA: 72 hours

Onboarding time: 3–21 days

Pricing model: Retainer

Starting from: GBP 2,200

Device Classes: Class I, Class IIa, Class IIb

GB Coverage: Yes

Services: Vigilance

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Libera Voce (UKRP)

Libera Voce Consulting offers bespoke UK Responsible Person (UKRP) services, specializing in Quality Assurance (QA), Regulatory Affairs (RA), and comprehensive business development. They cater to the medical device and pharmaceutical sectors, focusing on ensuring regulatory compliance and fostering business growth. Their approach is 'made to measure,' meaning they tailor their consulting services, including organizational development, audits, and mentoring, to the specific needs of each client.

Libera Voce Consulting provides specialized UK Responsible Person (UKRP) services, focusing on Quality Assurance (QA) and Regulatory Affairs (RA) for businesses in the medical device and pharmaceutical industries. Established to bring order and strategic development to organizations, they offer made-to-measure consulting, audits, and mentoring. With expertise in MDR and IVDR requirements, ISO13485 Quality Management Systems, and ISO13485:2016 transitions, Libera Voce supports clients in navigating complex regulatory landscapes. Their services extend to QA/RA training, ISO audit support, and environmental/CSR services. The team, including Tim Briffitt with 20 years of experience, is dedicated to optimizing processes and ensuring compliance. Libera Voce is committed to client needs, offering a bespoke approach to business development and regulatory challenges. They also aim to create employment opportunities through work placements for individuals seeking flexible, remote roles.

Website: liberavoce.co.uk

HQ: Reading, UK

Jurisdictions: UK

Countries: GB

Languages: English

Response SLA: 72 hours

Onboarding time: 3–21 days

Pricing model: Retainer

Starting from: GBP 2,000

GB Coverage: Yes

Services: Vigilance

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LFH Regulatory (UKRP Guidance & Support)

LFH Regulatory offers AI-powered medical device regulatory submission services, specializing in FDA and global market compliance. They provide expert guidance and streamlined workflows for submissions like 510(k), De Novo, and PMA.

LFH Regulatory provides comprehensive AI-powered regulatory services designed to streamline medical device submissions for both FDA and global markets. Their platform offers intelligent automation, automated compliance checks, and expert guidance throughout the entire submission process. Services cover a range of regulatory needs, including FDA 510(k) submissions, De Novo Classification Requests (eSTAR), Q-Submissions (Pre-Sub), 513(g) Requests, PMA Supplements, and Humanitarian Device Exemptions (HDE). They also support IDE Submissions. The company emphasizes a complete workflow from device classification to the final submission package, aiming to simplify complex regulatory requirements. For novel, low to moderate-risk devices, LFH Regulatory highlights the mandatory eSTAR use from October 1, 2025. They also offer formal device classification determination and support for 180-day, Real-Time supplements with repeatable templates and checklists. Their platform aims to be a single, intelligent solution for all regulatory needs.

Website: lfhregulatory.co.uk

HQ: Edinburgh, UK

Jurisdictions: UK

Countries: GB

Languages: English

Response SLA: 48 hours

Onboarding time: 3–21 days

Pricing model: Per project

Starting from: GBP 1,000

Device Classes: Class I, Class IIa, Class IIb

GB Coverage: Yes

Services: Vigilance

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UK Market Access Partners (UKRP)

UK Market Access Partners (UKRP) provides expert medical device lifecycle management services, including UK Responsible Person (UKRP) services for manufacturers outside the UK.

UK Market Access Partners (UKRP) offers comprehensive medical device lifecycle management, guiding manufacturers from concept and design through to market access and post-market surveillance. They specialize in ensuring compliance and audit readiness for MedTech and BioTech companies of all sizes. A key service is acting as the UK Responsible Person (UKRP), a mandatory requirement for non-UK-based manufacturers wishing to place medical devices on the Great Britain market, as stipulated by the UK Medical Devices Regulation 2002. UKRP facilitates smoother market entry and ongoing compliance for international clients. Evnia, the entity behind UK Market Access Partners, leverages industry knowledge and proprietary tools to transform challenges into opportunities. They help clients shorten time-to-market and support day-to-day business operations both pre- and post-market. Their services are tailored to the unique needs of each medical product, adding clinical and commercial value to portfolios and enabling companies to take their innovations to international markets faster and with less risk.

Website: ukmarketaccesspartners.co.uk

HQ: Manchester, UK

Jurisdictions: UK

Countries: GB

Languages: English

Response SLA: 48 hours

Onboarding time: 3–21 days

Pricing model: Onboarding + annual retainer

Starting from: GBP 3,200

GB Coverage: Yes

Services: Vigilance

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Apotech Consulting

Apotech Consulting provides comprehensive regulatory representative services for medical devices, IVDs, and cosmetics. They offer UK Responsible Person (UKRP), EU Authorised Representative (EUAR), Person Responsible for Regulatory Compliance (PRRC), and representative services in other countries. With global expertise spanning UK, EU, and US markets, Apotech helps manufacturers ensure regulatory compliance and market access.

Apotech Consulting is a global life science regulatory consulting firm specializing in representative services for medical devices, in vitro diagnostics (IVD), and cosmetic products. They provide UK Responsible Person (UKRP) services for UK market access, EU Authorised Representative (EUAR) services for EU market access, and Person Responsible for Regulatory Compliance (PRRC) services. Apotech has helped over 120 MedTech and IVD manufacturers navigate global regulations. Their services include device registration, regulatory oversight, technical documentation management, market surveillance, incident reporting, and serving as the point of contact with regulatory authorities. With consultants available in every major global country, Apotech offers tailored advice and guidance to represent manufacturers worldwide.

Website: apotechconsulting.com

HQ: Washington, US

Jurisdictions: UK

Countries: UK

Languages: English

Response SLA: 48 hours

Onboarding time: 7–21 days

Pricing model: Custom pricing

GB Coverage: No

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UK Responsible Person

QCS International, a subsidiary of PHSC plc, is a registered UK Responsible Person (UK RP) with the Medicines and Healthcare Products Regulatory Agency (MHRA). They specialize in assisting manufacturers located outside the UK to export medical devices into the UK market. With over 15 years of experience in medical device regulations, QCS International ensures compliance with the amended UK Medical Devices Regulations 2002 (UK MDR 2002) and post-Brexit regulatory requirements. Their service is cr

The UK Responsible Person (UK RP) for this directory listing is the Home Office. As a key UK government department, the Home Office is responsible for a wide range of public services including immigration, security, and law and order. Their media presence is managed through official channels, including the 'Home Office in the media' blog, which provides updates on home affairs-related stories, official statements, and ministerial comments. This blog serves as a primary source for news reviews, responses to breaking news, and rebuttals to inaccurate reports. The Home Office also maintains a dedicated media enquiry service for journalists. This service provides a news desk for inquiries, operating during specific hours with an out-of-hours option for urgent matters. It is important to note that the press office is unable to answer calls from members of the public, directing them to alternative contact methods for specific services like UK Visas and Immigration or general public inquiries.

Website: qcsl.co.uk

HQ: United Kingdom, UK

Jurisdictions: UK

Countries: UK

Languages: English

Response SLA: 48 hours

Onboarding time: 7–21 days

Pricing model: Custom pricing

GB Coverage: Yes

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GlobalCompliance Solutions Pro

Leading global regulatory compliance consultancy serving medical device manufacturers worldwide with comprehensive regulatory services.

Website: globalcompliance-solutions.com

HQ: Boston, US

Jurisdictions: EU, UK, US

Countries: DE, FR, GB, US

Languages: English, French, German, Spanish

Response SLA: 24 hours

Onboarding time: 7–30 days

Pricing model: Custom pricing

Device Classes: Class I, Class IIa, Class IIb

GB Coverage: Yes

Services: Vigilance

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MedReg International Pro

Specialized regulatory consultancy providing end-to-end compliance solutions for medical devices, IVDs, and combination products across all major markets.

Website: medreg-international.com

HQ: London, UK

Jurisdictions: EU, UK, US

Countries: DE, FR, GB, US

Languages: English, French, German, Spanish

Response SLA: 24 hours

Onboarding time: 7–30 days

Pricing model: Custom pricing

Device Classes: Class I, Class IIa, Class IIb

GB Coverage: Yes

Services: Vigilance

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Regulatory Excellence Partners Pro

Boutique regulatory consultancy offering personalized, high-touch regulatory services for innovative medical device companies and startups.

Website: regulatoryexcellence.com

HQ: San Francisco, US

Jurisdictions: EU, UK, US

Countries: DE, FR, GB, US

Languages: English, French, German, Spanish

Response SLA: 24 hours

Onboarding time: 7–30 days

Pricing model: Custom pricing

Device Classes: Class I, Class IIa, Class IIb

GB Coverage: Yes

Services: Vigilance

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DDReg Pharma

DDReg Pharma is a trusted global partner in the life sciences industry, delivering specialized consulting across Regulatory Affairs, Pharmacovigilance, Quality Assurance, and Clinical Research.

DDReg Pharma is a trusted global partner in the life sciences industry, delivering specialized consulting across Regulatory Affairs, Pharmacovigilance, Quality Assurance, and Clinical Research. With expertise spanning multiple regulatory jurisdictions and therapeutic areas, DDReg Pharma helps pharmaceutical, biotechnology, and medical device companies navigate complex regulatory landscapes.

Website: ddregpharma.com

Jurisdictions: UK

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Comprehensive Buyer's Guide

1. Who Needs a UK Responsible Person?

Under UK Medical Devices Regulations 2002 (as amended)^[1], non-UK manufacturers placing medical devices or IVD on the Great Britain market must appoint a UK Responsible Person (also called UKRP or MHRA responsible person)^[1].

This requirement applies to:

Non-UK medical device manufacturers placing devices on the Great Britain market^[1] — a UK Responsible Person is mandatory for market access
Non-UK IVD manufacturers placing IVD on the Great Britain market^[1] — requires UKRP services under UK regulations
Manufacturers transitioning from EU regulations to UK regulations post-Brexit — must appoint a UKRP for Great Britain market access
New market entrants from outside the UK — need a UK Responsible Person before placing devices on the Great Britain market

Note: The UKRP must be established in the UK (England, Scotland, or Wales)^[1] and cannot be the same entity as your importer or distributor for the same device^[1]. Northern Ireland follows EU regulations and requires an EC REP, not a UKRP.

References

The Medical Devices Regulations 2002 (SI 2002/618, as amended) (UK Government) — 2002-06-13 — Regulation 45A

2. What Services Are Typically Included?

UK Responsible Person services (also called UKRP services or MHRA responsible person services) typically include:

Regulatory representation: Acting as your legal representative in the UK for regulatory purposes^[1] — the UKRP fulfills this core requirement
Technical documentation access: Maintaining access to your technical documentation for MHRA^[1] — required for UK Responsible Person compliance
MHRA communication: Serving as contact point with UK competent authorities^[1] — the UKRP handles all regulatory communications
Vigilance support: Handling incident reporting and field safety corrective actions^[1] — essential for UKRP compliance
Post-market surveillance: Supporting PMS activities and periodic safety update reports^[1] — part of UK Responsible Person obligations
Change notifications: Managing notifications for device changes to MHRA
MHRA registration support: Some UKRP providers assist with MHRA device registration and UKCA marking requirements

References

The Medical Devices Regulations 2002 (SI 2002/618, as amended) (UK Government) — 2002-06-13 — Regulation 45A

3. What Affects Pricing?

UK Responsible Person pricing (also called UKRP cost or UKRP pricing) varies based on:

Device classification: Class III^[1] and IVD Class D devices typically cost more than Class I — UKRP services pricing reflects risk level
Portfolio size: Number of devices and device families — UK Responsible Person providers may charge per device or per portfolio
Service scope: Basic UKRP representation vs. full regulatory support including MHRA registration, vigilance, and PMS
Surveillance needs: Post-market surveillance and PSUR requirements^[1] — comprehensive UKRP services include ongoing surveillance
Change frequency: How often you make device changes requiring MHRA notifications — affects UKRP pricing
Contract terms: Annual retainer vs. per-device fees — UK Responsible Person pricing models vary by provider
MHRA registration support: Providers offering MHRA registration assistance may charge additional fees

References

The Medical Devices Regulations 2002 (SI 2002/618, as amended) (UK Government) — 2002-06-13 — Schedule 2A (Classification)

4. How to Choose a Provider

Key factors to consider when selecting a UK Responsible Person:

UK establishment: Verify they're established in the UK (England, Scotland, or Wales)^[1] — required for UKRP services
Device class experience: Confirm experience with your device classifications, especially Class III^[1] and IVD Class D
UK regulatory expertise: Verify they understand UK Medical Devices Regulations and post-Brexit transition requirements^[1] — essential for UKRP compliance
Vigilance capabilities: Assess their incident reporting and FSCA handling^[1] — UK Responsible Person must handle vigilance
Response times: Verify SLA for MHRA requests and change notifications — UKRP responsiveness is critical
Additional services: Check if they offer MHRA registration support, EU AR services, or other complementary services
Conflict of interest: Ensure they're not also your importer/distributor^[1] — UKRP must be independent
UKCA marking support: Some UK Responsible Person providers assist with UKCA marking requirements

References

The Medical Devices Regulations 2002 (SI 2002/618, as amended) (UK Government) — 2002-06-13 — Regulation 45A

5. Great Britain vs Northern Ireland (UKRP vs EU AR)

The UK market is split operationally:

Great Britain (England, Scotland, Wales): UK Responsible Person applies for non-UK manufacturers placing devices on the GB market^[1].
Northern Ireland: often follows EU rules for many device workflows^[2]; EU Authorized Representative (EC REP) coverage may be required depending on establishment and route^[2].

If you sell into both GB and NI, many manufacturers end up needing both UKRP and EU AR coverage. The UK Responsible Person handles Great Britain market access, while an EC REP handles Northern Ireland.

References

The Medical Devices Regulations 2002 (SI 2002/618, as amended) (UK Government) — 2002-06-13 — Regulation 45A
MHRA — Northern Ireland and medical devices (MHRA) — 2021-01-01

6. UKRP Onboarding Checklist (What to Prepare)

To get accurate UK Responsible Person quotes and onboard quickly, prepare:

Manufacturer entity details and authorized signatories
Device list with UK classifications^[1], intended use, and portfolio size
Labeling/IFU samples (UKRP details + UKCA/CE context^[1])
MHRA registration plan (if you need support with registration workflows^[1])
Vigilance contacts and escalation paths for incidents/FSCA^[1]
Technical documentation overview (summaries of technical files, not full files initially)
Quality management system certificate (ISO 13485^[2])

References

The Medical Devices Regulations 2002 (SI 2002/618, as amended) (UK Government) — 2002-06-13 — Regulation 10, Schedule 2A
ISO 13485:2016 — Medical devices — Quality management systems (ISO) — 2016-03-01

7. Typical Timeline (Selection → Appointment → MHRA Readiness)

UK Responsible Person timelines depend on your documentation readiness and whether you need MHRA registration support:

Provider selection: 1–2 weeks — compare UKRP services and pricing
Appointment + onboarding: 1–4 weeks — UKRP appointment and documentation review
Label updates: 2–6 weeks — update labels with UKRP details and UKCA marking^[1]
MHRA registration support: varies by device class^[1] and workload — some UK Responsible Person providers offer registration assistance

Once the UKRP is appointed and registered with MHRA^[1], you can typically start placing devices on the Great Britain market.

References

The Medical Devices Regulations 2002 (SI 2002/618, as amended) (UK Government) — 2002-06-13 — Regulation 10, Regulation 45A

8. Contract & Liability: What to Compare

Before you pick a UK Responsible Person, compare:

Scope: GB-only vs broader support; portfolio coverage and change terms — UKRP services scope varies by provider
MHRA comms: response SLAs, handling of urgent notices^[1], escalation procedure — UKRP must respond promptly to MHRA requests
Liability + insurance: caps and indemnities (make sure they're clear) — UK Responsible Person assumes regulatory responsibility^[1]
Termination + transition: notice periods, handover responsibilities — UKRP contracts should define transition terms
Pricing transparency: Understand UKRP cost structure — annual retainer vs. per-device fees

References

The Medical Devices Regulations 2002 (SI 2002/618, as amended) (UK Government) — 2002-06-13 — Regulation 45A

Frequently Asked Questions

Q1: What is a UK Responsible Person (UKRP)?

A UK Responsible Person (also called UKRP or MHRA responsible person) is a legal entity established in the UK that acts on behalf of non-UK manufacturers to fulfill regulatory obligations for placing medical devices and IVD on the Great Britain market under UK Medical Devices Regulations 2002^[1]. The UKRP serves as the manufacturer's representative and is responsible for ensuring devices comply with UK medical device regulations^[1]. Key responsibilities include: verifying the manufacturer has appropriate technical documentation and quality management systems^[1], keeping technical documentation available for UK authorities (MHRA)^[1], cooperating with MHRA on corrective actions and field safety notices^[1], informing MHRA of device incidents and field safety corrective actions^[1], and acting as a contact point between the manufacturer and UK authorities^[1]. The UK Responsible Person must be established in the UK^[1] and cannot be the same entity as the importer or distributor for the same device^[1].

References

The Medical Devices Regulations 2002 (SI 2002/618, as amended) (UK Government) — 2002-06-13 — Regulation 45A

Q2: Is UKRP required for IVD as well?

Yes, UK Responsible Person requirements apply to both medical devices and in vitro diagnostic devices (IVD) placed on the Great Britain market^[1]. After Brexit, the UK implemented its own regulatory framework (UK MDR 2002 as amended)^[1], which requires non-UK manufacturers of both medical devices and IVD to appoint a UKRP^[1]. Many UKRP services providers support both medical devices and IVD, though some may specialize in one or the other. When evaluating UK Responsible Person providers, confirm their experience with your specific device types (medical devices vs. IVD) and classifications, as IVD has distinct regulatory requirements and classification rules under UK regulations^[1].

References

The Medical Devices Regulations 2002 (SI 2002/618, as amended) (UK Government) — 2002-06-13 — Regulation 45A

Q3: What impacts UKRP pricing?

UK Responsible Person pricing (also called UKRP cost or UKRP pricing) varies based on several factors: device classification (Class I, IIa, IIb, III^[1], or IVD classes—higher risk classes typically cost more), portfolio size (number of devices and device families), service scope (basic UKRP representation vs. full regulatory support including vigilance, PMS, etc.^[1]), surveillance needs (post-market surveillance, periodic safety update reports^[1]), change management (frequency of device changes requiring notifications to MHRA), and contract terms (annual retainer vs. per-device fees). Some UK Responsible Person providers also charge setup fees, renewal fees, or fees for specific services like vigilance handling or MHRA registration support. Request detailed UKRP pricing breakdowns to compare effectively.

References

The Medical Devices Regulations 2002 (SI 2002/618, as amended) (UK Government) — 2002-06-13 — Schedule 2A (Classification)

Q4: What should I prepare when onboarding with a UKRP?

To streamline UK Responsible Person onboarding, prepare: device information (device names, GMDN codes, UDI-DI codes, classifications^[1]), technical documentation overview (summary of technical files, not full files initially)^[1], conformity assessment route (notified body certificates, self-declaration paths)^[1], existing registrations (if devices were previously on market under EU regulations), labeling and IFU samples (UKCA marking requirements^[1]), quality management system certificate (ISO 13485^[2]), and manufacturer details (company information, manufacturing sites). Some UKRP providers may also request a device portfolio list, risk management files summary, and clinical evaluation summaries. The exact requirements vary by UK Responsible Person provider and device complexity, but having these documents ready can significantly speed up the onboarding process, typically 2-6 weeks.

References

The Medical Devices Regulations 2002 (SI 2002/618, as amended) (UK Government) — 2002-06-13 — Regulation 10, Schedule 2A
ISO 13485:2016 — Medical devices — Quality management systems (ISO) — 2016-03-01

Q5: Can the same provider cover UKRP and EU AR?

Yes, many providers offer both UK Responsible Person and EU Authorized Representative (EC REP) services, which can be convenient for manufacturers selling in both Great Britain and the EU. However, these are separate regulatory roles with distinct requirements^[1]^[2]: UKRP is for the UK market (Great Britain)^[1], while EC REP is for the EU market^[2]. When evaluating providers offering both UKRP services and EU AR services, confirm: their UK establishment location (for UKRP^[1]) and EU establishment location (for EC REP^[2]), whether they can handle both roles under a single contract or require separate agreements, their experience with both UK and EU regulatory frameworks, and their ability to coordinate between UK and EU authorities when needed. Some manufacturers prefer separate providers to avoid potential conflicts, while others value the convenience of a single UK Responsible Person and EU AR provider.

References

The Medical Devices Regulations 2002 (SI 2002/618, as amended) (UK Government) — 2002-06-13 — Regulation 45A
Regulation (EU) 2017/745 (MDR) — Article 11 (European Union) — 2017-04-05 — Article 11

Q6: What is the difference between UKRP and EU Authorized Representative?

UKRP (UK Responsible Person)^[1] and EU Authorized Representative (EC REP)^[2] are similar roles but serve different markets. UKRP is required for non-UK manufacturers placing devices on the Great Britain market under UK medical device regulations^[1]. EC REP is required for non-EU manufacturers placing devices on the EU market under EU MDR/IVDR^[2]. While the roles are similar (both act as regulatory representatives, maintain technical documentation access, handle authority communications, and support vigilance), they operate under different regulatory frameworks^[1]^[2]. After Brexit, the UK has its own medical device regulations^[1], so manufacturers selling in both markets typically need both a UK Responsible Person and an EC REP. Some providers offer both UKRP services and EU AR services, but they require separate establishments (UK for UKRP, EU for EC REP) and may have different contract terms.

References

The Medical Devices Regulations 2002 (SI 2002/618, as amended) (UK Government) — 2002-06-13 — Regulation 45A
Regulation (EU) 2017/745 (MDR) — Article 11 (European Union) — 2017-04-05 — Article 11

Q7: How quickly can I get UKRP services set up?

UK Responsible Person setup timelines vary by provider and your readiness. Simple setups with complete documentation can take 2-4 weeks, while more complex portfolios may take 4-8 weeks. Factors affecting timeline include: completeness of your documentation, UKRP provider's processing speed and MHRA relationship, device complexity and classification^[1], whether you need MHRA registration support, and any language or translation requirements. Many UK Responsible Person providers offer expedited services for urgent cases, though this typically incurs additional fees. Once the UKRP is appointed and registered with MHRA^[1], you can usually start placing devices on the Great Britain market, though you'll need to ensure all other UK requirements (like UKCA marking^[1]) are met.

References

The Medical Devices Regulations 2002 (SI 2002/618, as amended) (UK Government) — 2002-06-13 — Regulation 45A

Q8: Do I need a UKRP if I only sell into Northern Ireland?

Northern Ireland often follows EU rules for many device workflows^[1], so UKRP may not be the right role for NI-only scenarios. If you sell into both Great Britain and Northern Ireland, you may need UK Responsible Person for GB^[2] and EU AR coverage^[1] depending on your establishment status. Confirm your route with a qualified UKRP provider.

References

MHRA — Northern Ireland and medical devices (MHRA) — 2021-01-01
The Medical Devices Regulations 2002 (SI 2002/618, as amended) (UK Government) — 2002-06-13 — Regulation 45A

Q9: Can an importer or distributor act as my UKRP?

Many manufacturers choose an independent UK Responsible Person to avoid conflicts of interest. UKRP and importer/distributor roles have different obligations^[1], and combining roles can create commercial and operational conflicts^[1]. The UKRP must be established in the UK and cannot be the same entity as your importer or distributor for the same device^[1]. Confirm role compatibility and contract scope with the UK Responsible Person provider.

References

The Medical Devices Regulations 2002 (SI 2002/618, as amended) (UK Government) — 2002-06-13 — Regulation 45A

Q10: Does a UKRP handle MHRA device registrations for me?

Some UK Responsible Person providers offer MHRA registration support^[1], but it's not universal. If you need help with account setup, registrations, updates, and change handling^[1], confirm the exact deliverables, SLAs, and UKRP pricing model with the provider. UKRP services may include MHRA registration assistance as an additional service.

References

The Medical Devices Regulations 2002 (SI 2002/618, as amended) (UK Government) — 2002-06-13 — Regulation 19 (Registration)

Q11: How is UKRP pricing usually structured?

UK Responsible Person pricing (also called UKRP cost or UKRP pricing) is usually structured as: annual retainers, per-device/per-family fees, tiering by device class/portfolio size^[1], and add-ons for high change frequency or vigilance support^[1]. Some UKRP providers also charge setup fees, renewal fees, or fees for specific services like MHRA registration support. Ask for a breakdown of base UK Responsible Person representation vs optional regulatory consulting to understand UKRP pricing fully.

References

The Medical Devices Regulations 2002 (SI 2002/618, as amended) (UK Government) — 2002-06-13 — Schedule 2A (Classification)

Provider Comparison Table

Provider	MDR/IVDR	Languages	Response SLA
Euverify Pro	EU, UK	Request quote	English	24h
Emergo by UL	UK	Request quote	English	Custom
OMC Medical (UKRP)	UK	Request quote	English	24h
Advena (UK Responsible Person)	UK	Request quote	English	24h
Qarad (UK Responsible Person)	UK	Request quote	English	24h
QbD Group (UKRP)	UK	Request quote	English	Custom
MDSS (UK Responsible Person)	UK	Request quote	English	48h
CMC Medical Devices (UKRP)	UK	Request quote	English	72h
8foldGovernance (UKRP)	UK	Request quote	English	24h
Freyr (UKRP Services)	UK	Request quote	English	Custom

Sources & Official Guidance

MHRA — UK Responsible Person (UKRP) guidance
Official UKRP guidance from MHRA.
UK Medical Devices Regulations 2002 (as amended)
Primary legal framework for medical devices in Great Britain.
MHRA — Register medical devices to place on the market
Official registration/market access guidance (includes UKRP context).

Last Updated: 2026-02-03

Reviewed by: Cruxi Regulatory Affairs Team

Best UK Responsible Person (UKRP) | Compare & Get Quotes

Compare Best UK Responsible Person (UKRP) | Compare & Get Quotes Providers

Euverify Pro

GlobalCompliance Solutions Pro

MedReg International Pro

Regulatory Excellence Partners Pro

Comprehensive Buyer's Guide

1. Who Needs a UK Responsible Person?

References

2. What Services Are Typically Included?

References

3. What Affects Pricing?

References

4. How to Choose a Provider

References

5. Great Britain vs Northern Ireland (UKRP vs EU AR)

References

6. UKRP Onboarding Checklist (What to Prepare)

References

7. Typical Timeline (Selection → Appointment → MHRA Readiness)

References

8. Contract & Liability: What to Compare

References

Frequently Asked Questions

Q1: What is a UK Responsible Person (UKRP)?

References

Q2: Is UKRP required for IVD as well?

References

Q3: What impacts UKRP pricing?

References

Q4: What should I prepare when onboarding with a UKRP?

References

Q5: Can the same provider cover UKRP and EU AR?

References

Q6: What is the difference between UKRP and EU Authorized Representative?

References

Q7: How quickly can I get UKRP services set up?

References

Q8: Do I need a UKRP if I only sell into Northern Ireland?

References

Q9: Can an importer or distributor act as my UKRP?

References

Q10: Does a UKRP handle MHRA device registrations for me?

References

Q11: How is UKRP pricing usually structured?

References

Related Regulatory Services

Provider Comparison Table

Sources & Official Guidance