UK Responsible Person (UKRP)

COMPLIANCE IN THE UNITED KINGDOM

Navigating UK regulations doesn’t have to be complicated. As your UK Responsible Person (UKRP), we help medical device manufacturers meet the requirements of the UK Medical Devices Regulations 2002 and confidently enter the British market.

What is a UKRP?

A UK Responsible Person is a UK-based person or company authorized in writing to act for a non-UK manufacturer, fulfilling their and the manufacturer’s obligations under the UK MDR 2002. We ensure that essential regulatory documents, including the Declaration of Conformity, Technical Documentation, and relevant conformity assessment certificates, are properly maintained and available when needed. We also keep copies of the required documentation ready for submission to the Medicines and Healthcare products Regulatory Agency (MHRA) upon request and register devices with the MHRA before they are placed on the Great Britain market.

From supporting the application of appropriate conformity assessment procedures to coordinating regulatory inquiries and documentation requests, we help keep processes efficient, transparent, and on track.

You focus on developing innovative medical devices. We take care of the regulatory communication that helps bring them to market.

What MEDAGENT handles

With MEDAGENT INTERNATIONAL UK LTD, you benefit from a dedicated UK-based team and extensive regulatory expertise. Our mission is to make meeting UK requirements easier and your path to market smoother, we:

Act as your designated UK Responsible Person through MEDAGENT INTERNATIONAL UK LTD
Register your organisation and applicable devices with the MHRA
Check the Declaration of Conformity, technical documentation and ensure relevant certificates are available
Keep required copies accessible for MHRA inspection
Coordinate authority questions and information requests directly with you and your team
Support updates when products, certificates, importers or registration information change

Getting UK Ready

Simple, fast successful: MHRA registration in just three steps.

1. Receive Our Templates

Getting your medical devices registered with the MHRA shouldn’t be complicated. That’s why we make the process as straightforward as possible. With customized registration templates, pre-filled with essential company and product information, we reduce administrative effort and keep your registration moving efficiently.

Our experienced team manages registrations through the MHRA database, supporting up to 100 product groups based on GMDN codes and 20,000 individual items per registration, where applicable. We review your Technical Documentation for completeness and accuracy, check that the required documents are up to date, and provide actionable feedback.

If something needs attention, we don’t just point it out. We help you find the right solution, ensuring the necessary documentation is available to your UK Responsible Person in accordance with UK MDR 2002 requirements.

The Right Strategy Saves More Than Time: We help you navigate MHRA registration requirements, identify suitable registration strategies, and also consider the most cost-effective approach to applicable annual MHRA fees.

2. Fill in Templates

While you complete the templates provided by us, we’re already working behind the scenes, reviewing your documentation and making sure everything is on track. If you have any questions along the way, we’ve got you covered. Our experts guide you through the process, helping you prepare accurate and complete information for a smooth registration. We will be at your side during the entire process.

Once you’ve returned the completed templates, it’s our turn to take care of the rest. We carefully review your submissions, address any outstanding details with you, and initiate the registration of your medical devices in the MHRA database.

3. We handle the Rest

Your paperwork is done. Now it’s our turn to make things happen.

As your trusted UK Responsible Person, we take charge of the registration process, submitting all required information through the MHRA database and coordinating directly with the UK authority whenever needed.

We keep the process moving, handle regulatory communication, and keep you informed every step of the way. Once submitted, we monitor the registration status and guide you through any additional requirements until the process is complete.

Three Simple Steps One Clear Goal: Getting your medical devices registered in the UK with confidence, efficiency, and minimal effort on your side.

Discover OUR difference

Why manufacturers choose MEDAGENT

MEDAGENT INTERNATIONAL UK LTD was established with a dedicated purpose. We love to provide our clients with reliable, efficient, and expert UK Responsible Person services. The process is built around prepared templates, document review and guided submission, helping international teams organize a requirement that can otherwise feel fragmented.

Backed by over 25 years of regulatory experience and our international network, we combine in-depth knowledge of UK requirements with a hands-on approach that makes compliance simpler and market entry smoother. You also gain direct access to our wider MEDAGENT expertise across quality management, international market approvals and representative services if the UK is one part of a larger expansion plan.

Frequently Asked Questions

Who must appoint a UK Responsible Person?

Medical device manufacturers based outside the UK must appoint a UK Responsible Person when placing their devices on the Great Britain market.

Is a UK Responsible Person the same as an EU Authorised Representative?

No, they are separate roles under different regulatory frameworks. Following Brexit and the end of the transition period in 2020, Great Britain established its own regulatory framework for medical devices, introducing new requirements for manufacturers seeking access to the British market. A company selling in both Great Britain and the EU may need both. The distinction between Great Britain (England, Scotland and Wales) and the United Kingdom as a whole is important here, as special regulations relating to EU law continue to apply to medical devices in Northern Ireland.

What documents must be available?

As UK Responsible Person, we ensure that essential regulatory documentation is in place and available for MHRA inspection. This includes the Declaration of Conformity, Technical Documentation, and applicable conformity assessment certificates, including any amendments or supplements. We also coordinate the provision of additional compliance information requested by the MHRA.

Does MEDAGENT support ongoing changes after registration?

Absolutely. Our support doesn’t end once your products are registered. We help you navigate regulatory updates, manage relevant registration changes, and maintain communication with the MHRA. With MEDAGENT by your side, you benefit from ongoing regulatory expertise and tailored support that evolves with your business, oftentimes exceeding the scope of solely our responsibilities. Because successful market access is just the beginning.

Stay Informed & Ahead on Regulatory Changes

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