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 provider of regulatory compliance services, specializing in the medical device and in-vitro diagnostic sectors. They are a founding member of the UK Responsible Person Association, an alliance dedicated to promoting professional conduct and competence among UK Responsible Persons.
**Expertise & scope**
* **UK Responsible Person (UKRP) Services:** Advising on all aspects of regulatory compliance for placing medical devices and IVDs on the Great Britain market, including device registration with the MHRA.
* **Medical Device & IVD Consultancy:** Providing tailored support throughout the product lifecycle, from concept and design to post-market activities, for key global markets including the UK (UKCA), EU (CE Mark), and the US (FDA).
* **Person Responsible for Regulatory Compliance (PRRC) Services:** Assisting manufacturers in meeting the obligations detailed in Article 15 of the MDR and IVDR.
* **Quality Management System (QMS) Support:** Offering services to review and implement QMS, ensuring compliance with regulatory requirements and product safety.
* **Medical Device Single Audit Program (MDSAP):** Guiding manufacturers through compliance with ISO 13485 and country-specific regulatory requirements for MDSAP.
* **Mentoring Service:** Providing hands-on, personalized guidance to empower SMEs and individuals to achieve regulatory compliance independently.
**Reputation / proof points**
* Serves over 300 clients as a UKRP.
* Recognized as Medical Device Regulatory Consulting Company of the Year 2025 by Medical Tech Outlook.
Advena (UK Responsible Person) is a UK-based provider of regulatory compliance services, specializing in the medical device and in-vitro diagnostic sectors. They are a founding member of the UK Responsible Person Association, an alliance dedicated to promoting professional conduct and competence among UK Responsible Persons.
**Expertise & scope**
* **UK Responsible Person (UKRP) Services:** Advising on all aspects of regulatory compliance for placing medical devices and IVDs on the Great Britain market, including device registration with the MHRA.
* **Medical Device & IVD Consultancy:** Providing tailored support throughout the product lifecycle, from concept and design to post-market activities, for key global markets including the UK (UKCA), EU (CE Mark), and the US (FDA).
* **Person Responsible for Regulatory Compliance (PRRC) Services:** Assisting manufacturers in meeting the obligations detailed in Article 15 of the MDR and IVDR.
* **Quality Management System (QMS) Support:** Offering services to review and implement QMS, ensuring compliance with regulatory requirements and product safety.
* **Medical Device Single Audit Program (MDSAP):** Guiding manufacturers through compliance with ISO 13485 and country-specific regulatory requirements for MDSAP.
* **Mentoring Service:** Providing hands-on, personalized guidance to empower SMEs and individuals to achieve regulatory compliance independently.
**Reputation / proof points**
* Serves over 300 clients as a UKRP.
* Recognized as Medical Device Regulatory Consulting Company of the Year 2025 by Medical Tech Outlook.
Additional information
Advena (UK Responsible Person) focuses on simplifying complex regulatory compliance for small and medium-sized enterprises (SMEs). Their approach emphasizes building client knowledge and skills through mentoring, enabling independent management of regulatory requirements. They offer cost-effective solutions tailored to specific needs, covering the full regulatory approval cycle for medical devices and IVDs. Buyers can expect a partnership designed to ensure understanding and confidence in regulatory approaches, accelerating market access while managing risk effectively.
Key Highlights
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Advena (UK Responsible Person) provides UKRP services to 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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Recognized 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 specialized consultancy for In-Vitro Diagnostic (IVD) Regulation.
Source
“Advena are the only consultancy team you need to bring your In-Vitro Diagnostic Regulation (IVD) through the ever changing regulatory hurdles to approval.”
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Provides Person Responsible for Regulatory Compliance (PRRC) services for MDR and IVDR.
Source
“The role requires an excellent level of regulatory knowledge and experience, which is why Advena is your perfect choice to undertake this role for you.”
Certifications & Trust Signals
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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.”
Buyer Snapshot
Best for
- Small and medium-sized enterprises (SMEs) seeking regulatory guidance.
- Manufacturers needing a UK Responsible Person for GB market access.
- Companies requiring support with QMS implementation and compliance.
How engagement typically works
- Partnership-focused mentoring and guidance.
- Tailored, cost-effective consultancy services.
- Hands-on support throughout the product lifecycle.
Typical deliverables
- UKRP registration and compliance support.
- Medical device and IVD regulatory strategy.
- QMS documentation and implementation plans.
- MDSAP and ISO 13485 compliance guidance.
Good to know
- Best when seeking expert navigation of UK medical device regulations.
- Ideal for those prioritizing knowledge transfer and long-term compliance independence.
Pricing
Model:
Retainer
Public range:
Publicly listed: EUR 2; EUR 10 (Note: These appear to be placeholder or minimal example pricing)
Notes:
Based on publicly listed information; final fees depend on scope and specific services required.
“Pricing: EUR 2; EUR 10”
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 a gap analysis as a first logical step for MDSAP compliance. For mentoring, it offers tailored, on-demand support. For QMS, services include reviewing the current system, completing a GAP analysis, creating a roadmap, and implementing change.
Device Classes Supported
Class I, IIa, IIb, III (implied by general medical device consultancy)
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