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
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
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.
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.
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.
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.
- 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.