UK Authorised Representative

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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).

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

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).

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 UK RP provides necessary information on UK importers.

Vigilance Reporting

While manufacturers may report vigilance directly to the MHRA, the UK RP 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.

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.

Future-Ready

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

Contact us

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