UK Responsible Person Services

Dedicated UKRP for non UK manufacturers. MHRA liaison, documentation, registration, vigilance and communications. Practical guidance to maintain compliance, minimise risk and secure uninterrupted Great Britain market access.

Manufacturers based outside the United Kingdom must appoint a UK Responsible Person (UKRP) before placing medical devices on the Great Britain market. The UK Responsible Person acts on behalf of the manufacturer in relation to specified regulatory obligations and serves as an important point of contact with the Medicines and Healthcare products Regulatory Agency (MHRA).

MG Regulatory provides dedicated UK Responsible Person services to manufacturers seeking access to the Great Britain market. Our team supports manufacturers in meeting regulatory requirements while maintaining an efficient and compliant route to market.

As part of our service, we review regulatory documentation, support device registration activities, and assist manufacturers in maintaining compliance with applicable UK medical device legislation. We also provide ongoing support relating to regulatory changes, post-market obligations, vigilance activities, and regulatory communications.

With UK regulatory requirements continuing to evolve, manufacturers increasingly require a UKRP that offers not only representation but also practical regulatory guidance. Our objective is to help manufacturers maintain compliance, minimise regulatory risk, and preserve uninterrupted access to the UK market.

By partnering with MG Regulatory, manufacturers gain access to experienced regulatory professionals who understand both the regulatory framework and the practical challenges associated with commercialising medical devices in Great Britain.

Testimonials

MG Regulatory’s project plan mapped out every step of our regulatory submission in minute detail, which kept us on track for a smooth CE mark application. When unexpected questions came back from our notified body, the team responded quickly, often within 24 hours, without compromising on quality.

Dr Christopher

Founder & CEO

    MG Regulatory supported us with our CE MDR Readiness Assessment, and we found the team knowledgeable, thorough and detail-oriented throughout. We look forward to working with them again.

    Dr Nidun

    Founder & CEO

      MG Regulatory demonstrated strong technical competence in navigating the MDD to MDR transition, with a proactive approach to problem-solving and effective cross-functional collaboration.

      David Francis

      Director

        MG Regulatory brings a high level of regulatory expertise, strong cross-functional capability and real versatility. Their experience within the medical device field is clear in the way they approach projects.

        Martine Hallows

        Director

          Working with MG Regulatory was a very positive experience. The team is professional, reliable and operates to a high standard.

          Issam Ouaissa

          Regulatory Affairs & Market Access Managing Partner

            The team at MG Regulatory is conscientious, dependable and highly professional. They bring a strong sense of accountability and integrity to their work, and they are a reliable and supportive partner to work with.

            Helen George

            MedTech Professional

              FAQs

              Do I need a regulatory consultant?

              If you’re developing, manufacturing or commercialising a medical device, the field is incredibly regulated. It’s important to ensure every move you make aligns with regulatory requirements. We help you navigate UK, EU MDR and FDA requirements, reducing regulatory risk and accelerating market access.

              Can you determine whether my product is a medical device?

              Yes. We carry out regulatory classification assessments and provide documented justifications where a product falls outside the scope of UK MDR, EU MDR or FDA medical device regulations.

              Which regulatory markets do you support?

              We provide regulatory support for:

              • UK (UK MDR & UKCA)
              • European Union (EU MDR & CE Marking)
              • United States (FDA)
              What regulatory services do you offer?

              We support manufacturers with regulatory strategy, device classification, Technical Documentation, Quality Management Systems, clinical evaluation, risk management, post-market surveillance, UKRP, EU Authorised Representative and Regulatory Importer services.

              How can you help us get to market faster?

              By engaging with us early, we help define the correct regulatory pathway, identify compliance gaps, reduce costly delays and provide a clear roadmap to successful market access.

              Have More Questions?
              Contact Us for more.
              info@mgregulatory.com
              (+44) 7500 220288
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              At MG Regulatory, we provide expert regulatory guidance for medical device manufacturers seeking access to the UK, EU, and US markets.

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