UK Responsible Person (UKRP) for medical devices & IVDs

Now that the United Kingdom no longer part of the European Union, a European Authorized Representative is no longer recognized in Great Britain (collectively: England, Scotland and Wales). Instead, the MHRA requires its own version of a ‘UK Authorized Representative’ – a UK Responsible Person (UKRP).

What are the obligations of the UKRP? 

Have a registered business in the UK

Register the manufacturer’s devices with the MHRA

Register the manufacturer’s importers

Ensure the manufacturer has carried out the appropriate conformity assessment process and drawn up the relevant technical documentation

Keep available a copy of the technical documentation and the declaration of conformity

Be the point of contact between the manufacturer and the MHRA, where required to do so

Manufacturers may report vigilance to the MHRA; however, the UKRP must be made aware

And more

Download our Easy-to-Read infographic: Steps to Enter the UK market

Proposed Changes to the role of the UKRP 

The UKRP’s role is currently similar to that of the EU Authorized Representative (AR) under the old Directives (MDD/AIMDD/IVDD) – for now anyway. The MHRA has proposed major regulatory changes by 2023, including to the role of the UKRP.

The role of the EU AR has become more stringent under the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Devices Regulation (IVDR). For example, under the MDR/IVDR, the EU AR must appoint a Person Responsible for Regulatory Compliance (PRRC), and the MDR/IVDR makes the EU AR equally liable for defective products placed by a manufacturer onto the European market.

The UKRP does not currently have those levels of responsibility. However, under the MHRA’s proposed regulatory changes, the role of the UKRP is likely to grow to the same level. For example, the MHRA has proposed that the UKRP must appoint a Quality Person and to make the UKRP equally liable for defective products placed onto the Great Britain market by a manufacturer.

When is the deadline to appoint a UKRP?

As of 1 January 2022, appointment of the UK Responsible Person is mandatory before products can be placed onto the Great Britain market. The UKRP is also responsible for registering the manufacturer’s devices with the MHRA. If a manufacturer places devices onto the Great Britain market without completing these steps, the manufacturer is out of compliance.

The MHRA previously implemented transition deadlines to appoint a UKRP and register devices. However, these deadlines have now passed.

Previous Transition Deadlines

    • 1 May 2021 – AIMD/Class III/Class IIb implantable/IVD List A
    • 1 September 2021 – Class IIb non-implantable/Class IIa/IVD List B/IVD self-test
    • 1 January 2022 – Class I/General IVDs/custom-made devices

Does the UKRP need to be on the labeling?

The short answer is:

  • No – not if you are placing devices onto the market based on your CE marking
  • Yes – if you are placing devices onto the market based on your UKCA marking

The extended answer is:

  • No – manufacturers are currently allowed to place devices onto the Great Britain market based on their CE marking. This is due to a transition allowance granted by the MHRA. Once the transition period ends, manufacturers must obtain UKCA marking in order to continue placing devices onto the Great Britain market. In the meantime, while manufacturers are marketing based on their CE marking, they are not required to update their labeling and the UK representative’s information is not needed on the labeling.
  • Yes – once a manufacturer has obtained UKCA marking, the UKRP must be on the device labeling.

For more information on the UKCA marking transition dates, please read: MHRA Officially Postpones UKCA Marking Deadline

Is there a UKRP symbol, simialr to the EC-REP or CH-REP symbol?

A UKRP symbol has not yet been released by the MHRA. Since there is only one national language in the UK, it is possible the MHRA will not release a UKRP symbol and instead will require the text ‘UK Responsible Person’ or ‘UKRP’ be written in English. If they opt for this route, it would be similar to the Australian Therapeutic Goods Administration (TGA). The TGA does not offer a symbol for Australian Sponsor, and instead requires ‘Australian Sponsor’ or ‘Sponsor’ to be written in English on the labeling.

Note that a UKCA marking symbol (similar to the CE marking symbol) is available and must be affixed when manufacturers obtain UKCA marking.

Northern Ireland

The UK is made up of four countries and all four countries have left the European Union. England, Scotland and Wales make up Great Britain. Great Britain will eventually require UKCA marking and already requires appointment of a UKRP and registration of devices with the MHRA.

The fourth UK country is Northern Ireland. Northern Ireland requires, and will continue to require, CE marking to lawfully place devices onto its market. MDR/IVDR registration requirements must be met for Northern Ireland. And where a manufacturer is not located in the EU / EEA, they are required to appoint an Authorised Representative to place devices onto the Northern Ireland market. However, a UKRP and device registration with the MHRA may still be required for Northern Ireland in some situations.

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