UK Responsible Person (UKRP)
A MD and/or IVD manufacturer?
Located outside the UK?
Selling in the UK?
If you are a non-UK based Medical Device and IVD manufacturer and want to sell in Great Britain (England, Wales and Scotland), you must appoint a UK Responsible Person (UKRP). The dedicated team at Psephos can assist you with a full regulatory Representative Service and ensure legal access to the Great Britain market.
Benefits of Appointing Us:
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25+ years of experience and integrity working within UK Health infrastructure
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Dedicated and supportive Representative Services Team
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Independent consultancy with no conflict of interest
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Quotations are bespoke with no unexpected or hidden fees
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Registered place of business in Brighton, UK
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Certified to ISO 13485:2016
Our UKRP Process:
Get in Touch
Send us your enquiry and tell us what you need.
Introductory Meeting
We’ll arrange a meeting to understand your products, requirements, and timelines.
Quotation
We’ll prepare a tailored quotation for our UKRP service.
Client Onboarding
We’ll collect the information needed to create your manufacturer profile and set you up correctly.
Agreement and Appointment as UKRP
Once you’re ready to proceed, we’ll put the commercial agreement in place.
MHRA Registration
We’ll review your technical documentation and certification, then we’re ready to register your products with the MHRA.
Why appoint Psephos to be your UK Responsible Person?​
As a UK Responsible Person we will commit to the following (as in line with UK MDR 2002):
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Ensure that the Client has put in place an appropriate declaration of conformity along with the correct technical documentation for their product and, where applicable, that an appropriate conformity assessment procedure has been applied.
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Register the Client’s devices with the MHRA.
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Keep available a copy of the Client’s technical documentation, a copy of the declaration of conformity and, if applicable, a copy of relevant certification, including any amendments and supplements for inspection by the MHRA.
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In response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a Client’s device.
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Respond to requests from the MHRA and forward any MHRA requests for samples or access to a device to the Client, ensuring that the MHRA requests are fulfilled.
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Cooperate with the MHRA on any preventive or corrective action (CAPA) taken to eliminate or, if that is not possible, mitigate the risks posed by Client’s devices.
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Immediately inform the Client about complaints and reports from healthcare professionals, patients and users about suspected incidents related to one of their devices.