The Role of a UK Responsible Person (UKRP)
Now that the United Kingdom no longer part of the European Union, an EU Authorized Representative is no longer recognized in Great Britain (collectively: England, Scotland and Wales). Northern Ireland, the fourth UK country still requires an EU Authorized Representative.
Instead, the MHRA requires its own version of a ‘UK Authorised Representative’ – a UK Responsible Person (UKRP).
The UK Responsible Person is responsible for 1) verifying you have CE or UKCA marked your medical devices, 2) submitting, managing, and renewing your device registrations, 3) notifying the MHRA of your UK importers and 4) acting as the point of contact between you and the MHRA when needed.
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
*These are requirements imposed on the UKRP, which are not required of an EU Authorized Representative. In Europe, it is not the EU Authorized Representative’s responsibility to register all of a manufacturer’s devices and system/procedure packs with the EU Competent Authorities, nor to register their importers.
When is the deadline to appoint a UKRP?
As of 1 January 2022, appointment of a UK Responsible Person is mandatory before a medical device or IVD can be placed onto the Great Britain market. The UKRP is also responsible for registering the manufacturer’s products 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 designate a UKRP and register devices. However, the transition period is now over.
Does the UKRP need to be on the labeling?
No, the UKRP does not need to be on your labeling if you are marketing based on your CE marking.
Yes, the UKRP does need to be on your device label or IFU if you are placing devices onto the market based on your UKCA marking.
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, if manufacturers are marketing based on their CE marking, they are not required to update their labeling, i.e., the UK representative’s information is not required on the medical device labels or instructions for use.
Once a manufacturer has obtained UKCA marking, then the “UKCA authorised representative” (UKRP) must be on the device labels or instructions for use.
For more information on the UKCA marking transition dates, please read: New Dates for UK Regulation & CE Marking
Is there a UKRP symbol, like 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 once manufacturers obtain UKCA marking.
Why Should You Choose Casus?
Our team has completed hundreds of UK registrations, so we know how to get you to market quickly and efficiently.
Our client onboarding is one of the fastest on the market – days compared to the weeks and months quoted by other providers. And our high-quality project management means you can be confident about the results.
We are transparent and fair – no hidden costs that you learn about too late, and no increased UKRP service fee if you add products later. Instead, you can expect straightforward, professional service from our knowledgeable team.
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 2025, 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 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 liable for a manufacturer’s defective products.