UK RESPONSIBLE PERSON

Who Needs UKCA Certification?

The appointment of a UK Responsible Person is a critical requirement under the UK Medical Devices Regulations (UK MDR 2002, as amended), serving as the official liaison between overseas manufacturers and the UK regulatory authorities. This role ensures that medical devices placed on the Great Britain market fully comply with all applicable UK laws and standards post-Brexit. To fulfill this responsibility, a formal, mutually signed agreement between the manufacturer and the UK Responsible Person must be established, clearly outlining the roles, obligations, and accountability of each party. This agreement serves as documented proof of compliance, giving regulatory bodies assurance that all devices meet the stringent safety and performance requirements necessary to protect public health.

The UK Responsible Person acts as the manufacturer’s representative within the UK, handling regulatory submissions, maintaining technical documentation, facilitating communications with the Medicines and Healthcare Products Regulatory Agency (MHRA), and supporting post-market surveillance activities.

At RAPS, we understand the evolving regulatory landscape and complexities manufacturers face in the UK market. Our expert team is committed to providing comprehensive UK Responsible Person services that ensure your products consistently meet regulatory expectations. We streamline compliance, mitigate risks, and facilitate seamless market access—allowing you to focus on product innovation and growth while we manage regulatory obligations on your behalf."

Benefits of Collaborating with a UK Responsible Person for MHRA Registration

Partnering with I3CGLOBAL as your UK Responsible Person (UKRP) brings significant advantages for foreign medical device and in-vitro diagnostic (IVD) manufacturers seeking to enter and thrive in the UK market.

Our team of seasoned UKRP consultants, regulatory experts, and auditors possess deep expertise in navigating complex device regulations across diverse product types. We provide tailored, practical advice and strategic guidance to help you meet all regulatory requirements with confidence.

But our support goes far beyond UKRP services. I3CGLOBAL offers end-to-end certification and compliance solutions, ensuring a seamless and comprehensive approach to your regulatory needs. We foster strong, collaborative business relationships, supported by flexible payment options accommodating clients from multiple countries worldwide.

Additional benefits include:

Free identification of the appropriate GMDN codes to simplify device classification.
Access to a global network of associated laboratories for biocompatibility and safety testing across multiple regions.
Expert assistance with clinical evaluation, clinical investigations, risk analysis, and risk-benefit assessments to support regulatory submissions.

Since 1999, RAPS has been a trusted partner and national regulatory representative for seven countries, delivering far more than administrative compliance. Our experienced professionals operate from our United Kingdom headquarters, offering hands-on regulatory services that ensure your medical devices meet all applicable requirements and achieve successful market access.

Moreover, we provide robust support in related areas such as:

Preparation and review of UKCA Technical Documentation,
Clinical and Biological Evaluations,
Coordination with Certification Bodies,
Implementation and maintenance of ISO 13485 Quality Management Systems.

By choosing RAPS as your UK Responsible Person, you gain a committed partner dedicated to streamlining your MHRA registration and regulatory compliance journey — helping you focus on innovation while we handle the complex regulatory landscape.

UK Responsible Person

Who Needs UKCA Certification?

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