UK Authorised Representative (UK RP) Service for Medical Device Manufacturers
If you sell medical devices in England, Scotland or Wales but you don’t have a base in these countries you may need the services of an UK Authorised Representative. Read on to learn more about what they do and our authorised rep services (UK RP).
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).
For non-UK based medical device manufacturers, a UK Authorised Representative adopts the following roles:
A key role of the UK Authorised Representative is to help ensure medical devices meet the necessary UK manufacturing standards including CE and UKCA marking requirements (delayed to December 2024).
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.
Acting as the intermediary between the manufacturer and the MHRA, the UK RP provides necessary information on UK importers.
While manufacturers may report vigilance directly to the MHRA, the UK RP can offer support in vigialnce activities.
As part of our commitment to compliance, we may request additional technical documentation to validate your product conformity with Medical Device Regulations.
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.
Our team has successfully completed hundreds of MHRA registrations, ensuring a swift and efficient market entry for our clients.
Experience a swift onboarding processes, reducing your wait time compared to other providers.
No hidden costs or increased fees for adding products later. We prioritise transparency, providing a professional service without surprises.
Anticipating changes in regulations, we are well-prepared for regulatory updates, ensuring our clients remain compliant.
Get in touch to speak to an advisor