UK Authorised Representative

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UK Authorised Representative (UKCA) Service for Medical Devices

If you sell medical devices in England, Scotland or Wales but do not have a base in these countries then you may need the services of an UK Authorised Representative – or UKCA Authorised Representative. Read on to learn more about what they do and our Authorised Representative services (UK RP).

Contents

Why do you need a UK Authorised Representative (UK RP) for medical devices?

Responsibilities of UK Authorised Representative for medical devices

Northern Ireland and Medical Devices

About our UK Representative Service for Medical Devices

UK Authorised Representative medical devices

Why do you need a UK Authorised Representative for Medical Devices?

With the UK’s exit from the European Union, an EU-based Authorised Representative is no longer recognised by the UK health regulator, the MHRA. Consequently, the MHRA introduced its own version of the Authorised Representative scheme—the UK Authorised Representative. As a result, all medical devices placed in England, Scotland, and Wales must be registered through a UK Authorised Representative. This change highlights the need for compliance with new UK-specific regulatory frameworks.

It is important to make the distinction that in England, Scotland, and Wales, devices must conform to the UK Medical Devices Regulations 2002. However, the requirements differ for Northern Ireland. Read on to learn more about these regional differences and how they impact the regulatory approach for medical devices within the UK.

UK Authorised Representative Responsibilities

For non-UK medical device manufacturers, a UK Authorised Representative – or UK RP – adopts the following responsibilities:

  • Verification of CE or UKCA Marking
  • Registration Management
  • Notification of UK Importers
  • Vigilance Reporting
  • Data Validation

Verification of CE or UKCA Marking

A key role of the UKCA Authorised Representative is to help manufacturers meet the necessary UK manufacturing standards including UKCA marking.

Registration Management

The UK Representative for medical devices acts on behalf of non-UK manufacturers to handle the submission and management of registrations with the MHRA.

Notification of UK Importers

Acting as the intermediary between the manufacturer and the MHRA, the UKCA Representative provides necessary information on UK importers.

Vigilance Reporting

While manufacturers may report vigilance directly to the MHRA, the UKCA Authorised Representative can offer support in vigilance activities.

Data Validation

As part of our commitment to compliance, we review device technical documentation to validate your product conformity with UK Medical Device Regulations.


Learn how to register a medical device in the UK here.


Northern Ireland and Medical Devices

Under the Northern Ireland Protocol, the EU medical device regulation applies Northern Ireland (EU Medical Devices Regulation), not the UK MDR 2002. Manufacturers outside EU and England, Scotland and Wales should appoint an EU or Northern Ireland-based Representative for products in Northern Ireland.

UK Representative Services for Medical Devices

Why choose us as your UK Representative partner

Read on to learn about why you should choose our UK Representative Services for medical devices (also UKCA Authorised Representative Services).

Proven Expertise

Our team has successfully completed hundreds of MHRA registrations, ensuring a swift and efficient market entry for our clients.

Fast Client Onboarding

We offer a smooth onboarding processes, reducing your wait time compared to other providers.

Transparent and Fair

No hidden costs. We are upfront about our pricing and provide a transparent, professional authorisation service.

Updates

Anticipating changes in regulations, we are well-prepared for regulatory updates, ensuring our clients remain compliant with UK MDR 2002.

Contact us today

Complete the form below or email info@medicpro.london to learn more about our UK Representative Services for Medical Devices.

FAQ

1. Do I need a UK Authorised Representative for medical devices?

Since the UK is no longer part of the EU, an EU Authorised Representative is no longer recognised by the MHRA. Consequently, the UK now mandates that all medical devices placed in England, Scotland, and Wales must be registered through a UK-located Representative. This change underscores the importance of adhering to the new regulatory requirements post-Brexit.

2. What is a UK Authorised Representative (UK RP) for medical devices?

A UK Authorised Representative – is a person, company or organisation that acts on behalf of a non-UK manufacturer (outside England, Scotland and Wales) to assist in compliance with UK medical device regulation. This includes offering an address in either England, Scotland and Wales.

3. What are the key responsibilities of a UK Authorised Representative for medical devices?

A key responsibility of a UKCA Authorised Representative is to verify CE or UKCA marking and manage device registrations with the MHRA. Additionally, they are tasked with notifying UK importers and supporting vigilance reporting activities.

4. What are the UK Authorisation Representative requirements?

Manufacturers outside England, Scotland, and Wales must appoint an UK Authorised Representative if they intend to place medical devices in these markets.

5. Who is the responsible person for Authorised representative UK?

The responsible person for authorised representative in the UK is a natural or legal person, company or organisation that is qualified and experienced in UK medical device regulation (UK MDR 2002).

6. What are the registration requirements for Northern Ireland regarding medical devices?

Under the Northern Ireland Protocol, EU medical device regulations continue to apply in Northern Ireland. Therefore, manufacturers from outside the EU, including those from England, Scotland, and Wales, should appoint an EU or Northern Ireland-based Authorised Representative for the placement of medical devices in Northern Ireland.

7. How can a US manufacturer comply with UK regulations for medical devices?

For compliance with UK MDR 2002, a manufacturer based in the United States must appoint a UK Representative to act on their behalf for registering medical devices in UK.

8. What benefits does using a UKCA Authorised Representative offer to manufacturers?

A UKCA Authorised Representative offers manufacturers efficient market entry through streamlined registrations and transparent processes. Additionally, they provide expert support in keeping up with regulatory updates and maintaining compliance with UK medical device regulation.

9. Who regulates medical devices in the UK?

The Medicines and Healthcare Products Regulatory Agency – or MHRA – which has offices in London, is the government body that regulates medical devices in the UK.

Contact us

Get in touch to speak to an advisor today.

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UK Medical Device Regulation 2002 (UK MDR 2002)