UK Authorised Representative
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UK Authorised Representative (UKCA) Service for Medical Devices
Whether you sell medical devices in England, Scotland or Wales then you may need the services of an UK Authorised Representative – also known as a UKCA Authorised Representative. Read on to learn more about what they do and our UK Representative services for medical devices.
Contents
Why do you need a UK Authorised Representative for medical devices?
Responsibilities of UK Authorised Representative for medical devices
Northern Ireland and Medical Devices
About our UK Representative Service for Medical Devices
Why do you need a UK 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 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 Representative Responsibilities for Medical Devices
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 for your medical device
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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