Advena (UK Responsible Person)
Advena Ltd
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.
About
**Who they are**
Advena (UK Responsible Person) is an experienced UK Responsible Person (UKRP) service provider based in the UK, advising on regulatory compliance for medical devices and in-vitro diagnostics entering the Great Britain market. They are a founding member of the UK Responsible Person Association (UKRPA), an alliance dedicated to promoting professional conduct and competence among UKRP service providers.
**Expertise & scope**
* Appointed as the UK Responsible Person for manufacturers based outside the UK who wish to place medical devices or in-vitro diagnostic devices on the Great Britain market.
* Advises on all aspects of regulatory compliance to ensure devices meet necessary requirements for the GB market.
* Responsible for registering devices with the UK's regulatory agency, the MHRA.
* Offers consultancy services for Medical Devices, In-Vitro Diagnostics, and Quality Management Systems.
* Provides Person Responsible for Regulatory Compliance (PRRC) services for both MDR and IVDR.
* Specializes in guiding manufacturers through the Medical Device Single Audit Program (MDSAP) and ISO 13485:2016 compliance.
* Offers a Mentoring service designed to empower SMEs and individuals to achieve regulatory compliance independently.
**Reputation / proof points**
* Serves over 300 clients as a UKRP.
* Recognised as the second-largest UKRP in the medical device market.
* Awarded Medical Device Regulatory Consulting Company of the Year 2025 by Medical Tech Outlook.
Advena (UK Responsible Person) is an experienced UK Responsible Person (UKRP) service provider based in the UK, advising on regulatory compliance for medical devices and in-vitro diagnostics entering the Great Britain market. They are a founding member of the UK Responsible Person Association (UKRPA), an alliance dedicated to promoting professional conduct and competence among UKRP service providers.
**Expertise & scope**
* Appointed as the UK Responsible Person for manufacturers based outside the UK who wish to place medical devices or in-vitro diagnostic devices on the Great Britain market.
* Advises on all aspects of regulatory compliance to ensure devices meet necessary requirements for the GB market.
* Responsible for registering devices with the UK's regulatory agency, the MHRA.
* Offers consultancy services for Medical Devices, In-Vitro Diagnostics, and Quality Management Systems.
* Provides Person Responsible for Regulatory Compliance (PRRC) services for both MDR and IVDR.
* Specializes in guiding manufacturers through the Medical Device Single Audit Program (MDSAP) and ISO 13485:2016 compliance.
* Offers a Mentoring service designed to empower SMEs and individuals to achieve regulatory compliance independently.
**Reputation / proof points**
* Serves over 300 clients as a UKRP.
* Recognised as the second-largest UKRP in the medical device market.
* Awarded Medical Device Regulatory Consulting Company of the Year 2025 by Medical Tech Outlook.
Additional information
Advena (UK Responsible Person) emphasizes a partnership approach, particularly with their Mentoring service, focusing on building client knowledge and skills for independent regulatory management. They cater to small and medium-sized enterprises (SMEs) by providing tailored, cost-effective support throughout the product lifecycle. Their services extend beyond UKRP to encompass broader regulatory consultancy, quality management systems, and PRRC functions, aiming to simplify complex compliance and accelerate market access for clients in key global markets including the UK, EU, and US.
Key Highlights
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Advena (UK Responsible Person) serves over 300 clients as a UKRP.
Source
“Providing UKRP services to over 300 clients, Advena UK is the second-largest UKRP in the medical device market.”
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Recognised as Medical Device Regulatory Consulting Company of the Year 2025.
Source
“Award-Winning Authority Recognised as Medical Device Regulatory Consulting Company of the Year 2025 by Medical Tech Outlook”
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Founding member of the UK Responsible Person Association (UKRPA).
Source
“We are a founding member of the UK Responsible Person Association, an alliance of UKRP service providers committed to promoting professional conduct and competence.”
Certifications & Trust Signals
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Established UK Responsible Person service provider.
Source
“As an experienced UKRP, Advena UK advises on all aspects of regulatory compliance to ensure your devices meet the necessary requirements for the GB market.”
Buyer Snapshot
Best for
- Manufacturers based outside the UK needing a UK Responsible Person.
- Companies seeking comprehensive medical device and IVD regulatory support.
- SMEs looking for tailored, cost-effective compliance solutions.
How engagement typically works
- Direct service provision for UKRP and PRRC roles.
- Consultancy and advisory services for regulatory strategy.
- Hands-on, personalized mentoring for knowledge transfer.
Typical deliverables
- UK Responsible Person registration and ongoing support.
- Regulatory compliance guidance for GB market entry.
- Quality Management System development and review.
- MDSAP and ISO 13485 compliance support.
Good to know
- Best when requiring a UK-based entity to act as the UK Responsible Person.
Pricing
Model:
Retainer
HQ:
Warwick, UK
Languages:
English
Timezones:
Europe/London
Claim status:
Listed
Services & Capabilities
Best UK Responsible Person (UKRP) | Compare & Get Quotes
Jurisdictions:
UK
Countries:
GB
Industries:
Medical devices, IVD, Healthcare
Portfolio:
26-100, 100+
Onboarding time:
3–21 days
Pricing model:
Retainer
Starting from:
GBP 5,000
Included services:
UK Responsible Person (UKRP) designation, MHRA liaison and communications forwarding, Support for registration process readiness, Vigilance escalation workflows and FSCA coordination, Labeling check for UKRP identification
Supports GB:
Yes
Supports NI:
No
MHRA Support:
Yes
Vigilance Support:
Yes
Additional uk_rp Details
Supports MDR
Yes
Supports IVDR
Yes
Supports GB
Yes
Vigilance Support
Yes
Post Market Support
Yes
UK Entity Country
England
Onboarding Steps
The process involves understanding client needs, providing tailored support, and ensuring devices meet regulatory requirements for market entry. For PRRC, Advena offers a cost-effective service to ensure obligations are met. For MDSAP, a gap analysis is a first logical step.
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