September 23, 2021
United Kingdom Responsible Person (UKRP) plays a major role in representing a non-UK manufacturer and their medical device product with the Medicines and Healthcare Products Regulatory Agency (MHRA). The UKRP, who is responsible for registration of devices with the MHRA, shall:
- Maintain Declaration of Conformity (DoC) and device technical documentation
- Be available for inspection
- Communicate with the manufacturer and the MHRA about complaints
- Implement Corrective & Preventive Actions (CAPA)
- Respond to any MHRA queries
Given the criticality of the role, it is essential for every device manufacturerto undertake a thorough evaluation of the prospects before appointing a UKRP.The manufacturer can adopt a 5-step process for appointing a UKRP, as depicted in the following flowchart:
5 step-progress For Appointing a UKRP
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Research
The manufacturer shall carry out thorough research to identify and shortlist the UKRP service providers. They should first:
- Understand the UK MHRA expectations from a UKRP
- Identify various service providers
- Verify service providers for their location and registration status
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Contact
Get in touch with the shortlisted entities and verify their credibility. You may prefer to know their experience as a UKRP. One-to-one verbal communication helps in better communication and a video call is suggested, if possible.
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Review
Obtain quotes from the entity and review them thoroughly. Evaluate inclusions and exclusions, terms and conditions, annual incremental costs, and any discount for multi-year contracts. UKRP cost is a recurring annual cost and one must ensure that sufficient amount is allotted in the annual budget.
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Appoint
Upon making the decision, ensure all the necessary agreements are signed between both the parties. Do not forget to cross-check the legal, Regulatory, payment and other terms before signing the agreement.
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Evaluate
The job does not end with appointing a UKRP. It is advisable to carry out a periodic review to ensure your UKRP is fulfilling the required responsibilities.
Checklist
- Is the entity acting as a UKRP located in the UK?
- Is the entity registered with the UK MHRA?
- Is the entity active and operational?
- Does the entity have the required QMS to fulfill the UKRP responsibilities?
As all said and done, while launching a product in the UK, non-UK manufacturers must ensure to adhere to the above 5-step process for appointing a UKRP. Are you aiming for UK market-entry for your device? Are you looking for assistance in appointing a UKRP? Take help of a proven Regulatory service provider. Stay informed. Stay compliant.
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