While the device manufacturers are exploring available options to appoint a UKRP, it is crucial to understand the significance of this role and what it takes an entity or individual to act as a UKRP. This article throws light on why having the right set of experiences is important to act as a UKRP. Post to Brexit and the release of new regulations & guidelines by the UK MHRA, there has been incredible demand in UKRP Services. Many individuals with a local presence in the UK have started claiming to act as a UKRP, and many companies have been blooming since then. These companies without experience are here only to make revenue out of the Regulatory requirements set by the UK MHRA and do not provide Regulatory compliance or customer satisfaction.
While choosing a UKRP, you need to appoint an appropriate person or entity as your UKRP. Many technical & Regulatory compliance aspects need to be maintained before making the final submissions to the UK MHRA. The UK MHRA has defined the roles and responsibilities of a UKRP and the UKRP that you appoint has to fulfill all the responsibilities. If your UKRP is experienced, you will have the following advantages:
1. Ensure compliance to technical documentation and declaration of conformity
When your UKRP is experienced and has delivered a considerable number of projects for a similar device class as yours, you can be completely sure that the technical documents reviewed by them will be up to the mark as they have already made submissions earlier to the UK MHRA and will have complete knowledge on the UK MHRA requirements. But, if the UKRP is very new in the industry, he might not be aware of the MHRA requirements and might end up submitting incomplete applications.
2. Timely submissions
If the UKRP is not experienced, then it is possible that they might not be able to make the submissions on time, and even if they do, there might be multiple queries from the UK MHRA for not submitting the technical information in an appropriate format or incomplete information due to which your product will take time to launch in the UK market. While, if your UKRP has the experience, they will ensure that the submissions done at the first time are up to the mark, and no queries will arise from it.
3. Handling the UK MHRA queries
While your UKRP makes the final submissions to the UK MHRA, it is possible that the submission is not up to the mark, and the UK MHRA might raise some queries. It is the responsibility of the UKRP to address these queries. But, if the UKRP is very new to the industry and has not made any earlier submissions for a similar type of device class, it is possible that the UKRP might not be able to handle the queries. Also, if the UKRP is not experienced, they might be able to handle the minor queries but not be able to handle the major questions, which will lead to a delay in launching your product in the market.
4. Quarterly reports on the UKRP service
When you appoint your UKRP, the UKRP must provide you with quarterly reports so that you can track the activities of the UKRP. Unless your UKRP is experienced, he won’t be providing you with quarterly reports so that you can keep track. It then boils down to you to ensure your UKRP is functioning and on top of the queries from the MHRA, which would be a burden and would not be a hands-free service you would hope to achieve.
Therefore, it is recommended that you appoint a UKRP who has prior experience in handling the submissions of the risk class as similar to your devices in scope. It will lead to smooth submissions and quick registration of your devices with the UK MHRA.
For hassle-free registration of your devices with the UK MHRA or to appoint a UKRP, book a free 30-minute consultation with Freyr. Stay informed. Stay compliant.