Pitfalls to Avoid While Choosing a UKRP

Pitfalls to Avoid While Choosing a UKRP

When the UK MHRA made it mandatory for the non-UK manufacturers to appoint a UKRP post-Brexit, many small and new organizations, including pseudo companies, started blooming in the UK, seeing huge market potential. Many existing companies in the UK got themselves registered as a UKRP and started to act as UKRP. However, some companies are offering UKRP services without substantial prior experience on MHRA Regulatory compliance, there exists a fair possibility of them being unable to fulfil all the roles and responsibilities of UKRP set by the UK MHRA. Also consider that many such UKRP service providers offer much cheaper rates than standard, as a measure to attract manufacturers. Device manufacturers are advised to not approach such heavily discounted UKRP service providers.

While choosing the appropriate UKRP, the manufacturer may end up choosing an inappropriate individual or entity. Here are some of the pitfalls that you can avoid while choosing a UKRP:

1. Choosing a UKRP with no registered entity in the UK

According to the requirements set by the UK MHRA, it is mandatory for your UKRP to have a registered office in the UK. If your UKRP is not based in the UK, you cannot appoint such an entity or individual as your UKRP as the UK MHRA will not consider it.

2. Choosing a UKRP with no dedicated team

If you are appointing an individual who has a registered office in the UK and is acting as your UKRP, you must make sure they have an appointed individual based out of the UK to understand the requirements of the MHRA and is supported by a team of relevant Regulatory professionals. If a single person is taking care of all the activities associated with the submissions, then there might be a delay in making your submissions.

3. Choosing a UKRP who has not handled the risk class similar to yours

If you end up choosing a UKRP who has not handled the device risk class similar to yours, it is possible that the UKRP is not aware of the requirements of that risk class, and hence it might lead to a delay for your submissions. It is also possible that the UK MHRA raises multiple queries that the UKRP cannot handle as he does not have much knowledge for that particular risk class and, most importantly, maintenance/PMS activities, which is a very important part of the product lifecycle, would be impacted. Therefore, this is also a very important point you must consider while appointing your UKRP.

4. Choosing a UKRP with no experience

If your UKRP does not have any experience, it is possible that he may compile an incomplete technical file. If the technical file compiled is incomplete, it will lead to incomplete submission on the online MHRA portal, and hence post submission, there will be a lot of major queries from the MHRA. Since the UKRP is not experienced, he might not be able to handle those queries from the MHRA, leading to a delay in launching your product in the UK. Therefore, you have to make sure that you appoint a UKRP who has good experience and successfully registered at least a few products with the UK MHRA.

5. Choosing a UKRP who fulfils all the responsibilities

It is very important that your UKRP fulfills all the roles and responsibilities set up by the UK MHRA. While you appoint your UKRP, you have to make sure that you and your UKRP agree on the responsibilities.

6. Choosing an economical option, not a cheaper one

There has been a considerable choice of organizations providing UKRP services in the UK; some offer at a significantly cheaper rate. However, they would not have the infrastructure or resources to fulfill the obligations pre- and post-registration. Please be aware of the obligations of the MHRA for your UKRP and ensure they have enough experience ahead of signing the agreements, as changing UKRP could be an expensive business.

It is essential to consider all these points while you choose your UKRP. You have to analyze multiple factors and consider various scenarios before you appoint your UKRP; especially speed to market is a top commercial strategy for any manufacturer, ensuring a fast launch for your product in the UK market.

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.

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