UK MHRA Medical Device Registration & UK Responsible Person (UKRP)

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UK Registration & Responsible Person (UKRP)

All medical devices must be registered before being placed onto the market. Foreign manufacturers must appoint a UKRP, and the UKRP will complete the registration on their behalf. The UKRP must fulfill the below responsibilities.

Designation Letter by Manufacturer to UKRP

Manufacturers may only appoint one UKRP for all its products. The UKRP must submit proof of designation.

Review the Device Documentation

The UKRP is required to verify that the correct conformity assessment route was applied.

Register medical devices with MHRA

All devices must be registered. The UKRP must complete the registration on behalf of its clients.

Register importers with MHRA

The UKRP is required to register importers for the manufacturers they represent.

Why should I choose Casus?

With hundreds of UK MHRA medical device & IVD submissions, we are experts in navigating the UK market. We get your products to market quickly with our streamlined process. 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.  

Is UKCA Marking required to sell in the UK?

The MHRA currently allows manufacturers to place devices onto the UK leveraging CE Marking. This is a transition period to ensure the UK market was not disrupted after ‘Brexit’. Once the transition period ends (2026-2028, depending on the type of device) UKCA Marking will be required to continue accessing the Great Britain market. NOTE: Northern Ireland, the fourth UK country, requires (and will continue to require) CE Marking.

What is the timing & cost to register?

The MHRA charges a fee of £100 for each registration. Up to 100 device families can be included under that £100 fee, if all are registered at the same time. The MHRA quotes a five-business day timeframe to review applications. However, the review time may be extended if the MHRA has a backlog of registrations. Casus' fee and timeframe to act as your UKRP and complete the registration is competitive. Request an obligation-free quote.

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Contact us today for a UK Medical Device Registration & UKRP quote or to schedule a Free Consultation. 

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