What is a UK Responsible Person (UKRP)?
In order to place a medical device or in-vitro diagnostic on the Great Britain (GB) market, manufacturers based outside the UK must appoint a UK Responsible Person (UKRP) with a registered place of business in the UK, as defined in the UK Medical Devices Regulations 2002 (SI 2002 No. 618, as amended).
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.
The Responsibilities of a UK Responsible Person (UKRP)
The UK Responsible Person must register devices with the UK’s regulatory agency, the MHRA, and is responsible for:
The role of a UK Responsible person (UKRP) is more than just a formality; it requires a deep understanding of complex regulatory requirements. This is why you need a knowledgeable and experienced partner.
Providing UKRP services to over 300 clients, Advena UK is the second-largest UKRP in the medical device market. We are a founding member of the UK Responsible Person Association, an alliance of UKRP service providers committed to promoting professional conduct and competence.
We have a dedicated UKRP team to ensure our clients receive the highest level of care and expertise. Our commitment to quality is underscored by our ISO 13485 certification, which specifically covers our UKRP services within its scope, giving you added assurance that we adhere to the highest international standards.
By choosing Advena UK, you can be confident that your regulatory compliance is in expert hands, allowing you to focus on your core business.
What our clients say
We work incredibly closely with our clients, offering a bespoke tailored service so you get
exactly what you need from us
Advena is the ideal partner for YUYU. Their quick communication, professionalism, and thoroughness make us highly satisfied. We highly recommend their services.
We have developed a great partnership with the team at Advena since we started working together in early 2022. We especially value their honest and straight forward approach to our Medical Device Regulatory needs. What has been most impressive is their ability to really understand what we actually want, while also making regulatory and commercial suggestions that help our business now & for the future. I have been impressed with all my points of contact within Advena and their professional & friendly manner. I am very happy that we have chosen Advena as our Regulatory partner as we move into the next phase of our business growth.
Advena’s friendly, professional and knowledgeable team have been an invaluable resource for us, helping us with our CE & UKCA IVDR transition, ensuring the continuity of compliance that our customers require and rely upon.
Working with Advena meant that we could focus on what we do best - developing cutting-edge AI-driven clinical decision support systems - with full confidence that our products meet the necessary Regulatory and Quality requirements. Professionalism and efficiency of Advena’s consultants allowed us to rapidly enter new markets, whilst prioritising patient safety.
Great customer support from the beginning of the process. The team go the extra mile to assist and provide information. Information provided has been accurate, responses to queries were turned around fast, were clear and where necessary detailed enough for us to make informed decisions.
We’re happy with the service Advena UK is providing us, and would definitely continue using their services.
We are very happy with the service we receive from Advena and from Jessica Ostle and her team. Communication is excellent and always timely. From the UK side everything has worked very well from day one until now. Very happy customers.
They are so kind and the services are so brilliant and active!
I found the process of signing up with Advena and then uploading and approving all our documentation (with respect to the role of UKRP) as quite efficient and well organised with good communication and support throughout the process).
Communications are quick and efficient, notifications of legislation changes are issued when applicable. Liaising with specialists/co-ordinators is painless (in comparison to my experience with other third parties). Advena have been very supportive and patient throughout, in a particular example with recent ‘’Brexit’’ artwork and UK RP changes for our cosmetic products. Internal projects have also been executed where Advena have demonstrated their continuous commitment to assist, engage and deliver. Advena have been a pleasure to collaborate with and their partnership is valued.
