UK Authorised Representative
You are here: Home \ UK Authorised Representative
UK Authorised Representative (UKCA) Service for Medical Devices
If you sell medical devices in England, Scotland or Wales but don’t 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 for medical devices?
Role of UK Authorised Representative for medical devices
Northern Ireland and Medical Devices
About our UK Authorised Representative (UK RP) Service
Why do you need a UK Authorised Representative for medical devices?
With the UK out of the European Union, an EU-based Authorised Representative is no longer recognised by the UK health regulator – the MHRA. The MHRA introduced its own version of the EU Authorised Representative scheme – the UK Authorised Representative – or Responsible Person (‘UKRP’). All medical devices, including in vitro diagnostics (IVDs), placed in England, Scotland and Wales must be registered with a UK-based Authorised Representative.
In England, Scotland and Wales, devices must conform to the Medical Devices Regulations 2002. However, registration requirements differ for Northern Ireland (read on to learn more).
Role of UK Authorised Representative for medical devices
For non-UK based medical device manufacturers, a UK Authorised Representative adopts the following roles:
- 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 ensure medical devices meet the necessary UK manufacturing standards including CE and UKCA marking requirements (delayed to December 2024).
Registration Management
The UK Authorised Representative acts on behalf of non-UK manufacturers to efficiently handle the submission, management, and renewal of device 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 vigialnce activities.
Data Validation
As part of our commitment to compliance, we may request additional technical documentation to validate your product conformity with 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 remains in place in Northern Ireland (EU Medical Devices Regulation and In vitro Diagnostic Medical Device Regulation). Manufacturers outside EU and England, Scotland and Wales should appoint an EU or Northern Ireland-based Authorised Representative.
About our UK Authorised Representative (UK RP) Service
Proven Expertise
Our team has successfully completed hundreds of MHRA registrations, ensuring a swift and efficient market entry for our clients.
Fast Client Onboarding
Experience a swift onboarding processes, reducing your wait time compared to other providers.
Transparent and Fair
No hidden costs or increased fees for adding products later. We prioritise transparency, providing a professional service without surprises.
Updates
Anticipating changes in regulations, we are well-prepared for regulatory updates, ensuring our clients remain compliant.
Contact us today
Complete the form below or email info@medicpro.london and we’ll be in touch.
FAQ
1. Why do I need a UK Authorised Representative for medical devices?
With the UK’s exit from the EU, an EU-based Authorised Representative is no longer recognised by the UK health regulator, MHRA. The UK now requires all medical devices placed in England, Scotland, and Wales to be registered with a UK-based Authorised Representative, ensuring compliance with UK manufacturing standards and regulations.
2. What are the key roles of a UK Authorised Representative for medical devices?
A UKCA Authorised Representative plays crucial roles such as verifying CE or UKCA marking, managing device registrations with the MHRA, notifying UK importers, supporting vigilance reporting activities, and validating data to ensure product conformity with Medical Device Regulations.
3. What are the registration requirements for Northern Ireland regarding medical devices?
Under the Northern Ireland Protocol, EU medical device regulations remain in place in Northern Ireland. Manufacturers outside the EU and England, Scotland, and Wales should appoint an EU or Northern Ireland-based Authorised Representative for placing medical devices in Northern Ireland.
4. How can a non-UK based manufacturer comply with UK regulations for medical devices?
Non-UK based manufacturers must appoint a UKCA Authorised Representative to act on their behalf for registering medical devices in Great Britain. This appointment is essential to ensure compliance with UK regulations and standards.
5. What benefits does using a UKCA Authorised Representative offer to manufacturers?
UKCA Authorised Representative provides manufacturers with efficient market entry through registrations, transparent processes without hidden costs, expert support in regulatory updates, and assistance in maintaining compliance with UK manufacturing standards.
Contact us
Get in touch to speak to an advisor
You might also be interested in…
EU MDR (Medical Device Regulation)
