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 a UK-based regulatory consultancy that provides services to medical device and in-vitro diagnostic manufacturers. They are a founding member of the UK Responsible Person Association and have served over 300 clients.
**Expertise & scope**
* UK Responsible Person (UKRP) services for placing medical devices on the Great Britain market.
* In-Vitro Diagnostic (IVD) consultancy covering the full regulatory approval cycle.
* Person Responsible for Regulatory Compliance (PRRC) services for MDR and IVDR.
* Quality Management System (QMS) implementation and review, including gap analysis and roadmap creation.
* Medical Device Single Audit Program (MDSAP) guidance, using ISO 13485 as a framework.
* Mentoring services designed to build client knowledge and skills for independent regulatory compliance.
* Consultancy for UK (UKCA), EU (CE Mark), and US (FDA) markets.
**Reputation / proof points**
* Recognised as Medical Device Regulatory Consulting Company of the Year 2025 by Medical Tech Outlook.
* Serves over 300 clients as a UKRP.
* Founding member of the UK Responsible Person Association.
Advena (UK Responsible Person) is a UK-based regulatory consultancy that provides services to medical device and in-vitro diagnostic manufacturers. They are a founding member of the UK Responsible Person Association and have served over 300 clients.
**Expertise & scope**
* UK Responsible Person (UKRP) services for placing medical devices on the Great Britain market.
* In-Vitro Diagnostic (IVD) consultancy covering the full regulatory approval cycle.
* Person Responsible for Regulatory Compliance (PRRC) services for MDR and IVDR.
* Quality Management System (QMS) implementation and review, including gap analysis and roadmap creation.
* Medical Device Single Audit Program (MDSAP) guidance, using ISO 13485 as a framework.
* Mentoring services designed to build client knowledge and skills for independent regulatory compliance.
* Consultancy for UK (UKCA), EU (CE Mark), and US (FDA) markets.
**Reputation / proof points**
* Recognised as Medical Device Regulatory Consulting Company of the Year 2025 by Medical Tech Outlook.
* Serves over 300 clients as a UKRP.
* Founding member of the UK Responsible Person Association.
Additional information
Advena Ltd operates from two locations in the UK: an Operations Office in Bromsgrove and a Head Office in Warwick. They specialize in simplifying complex regulatory compliance for small and medium-sized enterprises (SMEs), offering tailored and cost-effective support throughout the product lifecycle. Their services extend beyond initial market entry to include post-market activities and ongoing compliance maintenance. They emphasize building client expertise through their mentoring service, differentiating it from their direct consultancy solutions.
Key Highlights
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Advena UK is the second-largest UKRP in the medical device market, serving over 300 clients.
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 by Medical Tech Outlook.
Source
“Award-Winning Authority Recognised as Medical Device Regulatory Consulting Company of the Year 2025 by Medical Tech Outlook”
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Offers consultancy services for UK (UKCA), EU (CE Mark), and US (FDA) markets.
Source
“Our dedicated team delivers a comprehensive range of consulting and advisory services designed to help your medical device meet the requirements of key global markets, including the UK (UKCA), EU (CE Mark), and the US (FDA).”
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A founding member of the UK Responsible Person Association, promoting professional conduct.
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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Advena Ltd has an Operations Office in Bromsgrove and a Head Office in Warwick.
Source
“Operations Office - Advena Ltd Operations, Basepoint Business Centre, Isidore Road, Bromsgrove, B60 3ET United Kingdom Head Office - Advena Ltd Head Office, Pure Offices, Plato Close Warwick, CV34 6WE United Kingdom”
Buyer Snapshot
Best for
- Manufacturers needing UK Responsible Person services.
- Companies seeking IVD regulatory approval support.
- SMEs requiring guidance on MDR/IVDR compliance.
How engagement typically works
- Direct consultancy for ready-to-implement solutions.
- Mentoring for building in-house regulatory knowledge.
- Tailored, cost-effective support.
Typical deliverables
- UKRP registration and compliance.
- IVD regulatory approval strategy.
- QMS documentation and implementation.
- MDSAP audit preparation.
- PRRC appointment and support.
Good to know
- Best when requiring specialized regulatory expertise for the UK market and other global regions.
HQ:
Warwick, UK
Languages:
English
Timezones:
Europe/London
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:
Yes
MHRA 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 a gap analysis as a first logical step for services like MDSAP.
