Post the Brexit implementation, most of the Medical Device Industry stakeholders have been busy chalking their plans towards complying with new requirements and new UK MDR 2002 regulations. One critical need for the non-UK device manufacturers, who intend to market their products in the UK, is to appoint a UKRP. Manufacturers may either choose to appoint a reliable UKRP service provider or their importer/distributor to represent their device in the UK market. The manufacturer may wonder what questions they should ask their potential UKRP to evaluate their expertise and experience with the MHRA and the UK Medical Device regulations. Here is the list of top 10 questions a medical device manufacturer can ask their UKRP service provider -
1. Is there an established procedure in place to support the UK MHRA requirements?
The UKRP will be responsible for maintaining technical documentation, declaration of conformity, and registering your device with the MHRA. It would be ideal to have a streamlined process to fulfil these responsibilities in a compliant way. Though the UK MHRA does not require the UKRP to have a QMS, the manufacturer should ensure that their prospect UKRP has a basic QMS established.
2. Is the prospect registered with the MHRA?
The manufacturer has to make sure that the UKRP they appoint, either an individual or an entity, should have a registered office in the UK and be registered with the UK MHRA. If the manufacturers want to appoint their distributors or importers as their UKRP, they should make sure that the distributor or importer is registered with the UK MHRA to provide UKRP service.
3. How many devices is the entity or person responsible for?
Manufacturers may inquire about the number of devices that the person or entity currently represents in the UK market, the number of devices they have already registered with the MHRA, and the class of the registered devices. Manufacturers may also inquire about the queries raised by the MHRA while registering the devices and about the devices in the pipeline. The provided details would help manufacturers choose the right UKRP who has experience handling devices of the same category or risk class as their device portfolio in scope.
4. What are the credentials of the person acting as your UKRP?
With a surge in demand for UKRP, in recent times, many entities without a physical location in the UK have come up claiming to act as a UKRP. Manufacturers shall obtain the educational qualifications, prior experience of working in the Medical Device industry and liaising with the MHRA. The role of a UKRP is more than just being a communication channel. The role requires the review of a device’s technical documents, and one might not be able to ensure compliance without sound knowledge.
5. Is your UKRP capable enough to support you?
Manufacturers should know if the prospect UKRP is an individual or an established entity. In either case, manufacturers should know about the availability of additional resources to accommodate the registrations as well and give attention to their products. In an entity, manufacturers must know the team strength and may request the details of the individual taking care of their products. The manufacturer may also request to interact with the individual before making a final decision.
6. Does the prospect UKRP have a checklist of documents for registering the devices with the MHRA?
The manufacturers must know if the UKRP service provider is well equipped with the dynamic requirements of the MHRA, i.e., the UKRP must have an updated checklist of the documents required while submitting to the MHRA portal. Also, the UKRP must have the templates of the forms required while making an online submission on the MHRA portal.
7. What are the timelines for registering the devices with UK MHRA?
The manufacturer must be well aware of the timelines the UKRP has for making an online submission to the MHRA portal. If the UKRP service provider is taking more time than required, then in such cases, manufacturers can consider an alternative UKRP service provider who has a shorter turn-around time.
8. Will there be a different Letter of designation and Agreement between the entities?
The UKRP Agreement between the manufacturer and the Letter of designation are two different documents. The Agreement includes the roles and responsibilities of the UKRP for which both the parties have agreed upon with specific conditions agreed by both parties. At the same time, the Letter or designation consists of the standard text provided by the MHRA and would require to be printed on the manufacturer’s letterhead. The Letter of designation cannot be replaced by the Agreement as it must be uploaded in the MHRA database. Manufacturers should understand if their UKRP service provider has the necessary templates for each of these documents.
9. What would be the exit procedure for the UKRP Services?
The business landscape is quiet dynamic, and the organization needs to vary with the expansion plans. Manufacturers should know the support offered by the UKRP service provider if they choose to have a subsidiary in the UK or to appoint another UKRP service provider for their product to meet their business needs. The old UKRP service provider shall revoke the existing registration for the new UKRP to re-register the device in their name. Manufacturers must get a confirmation on their full co-operation in case such scenarios or situations arise. The conditions of exit must be documented in the UKRP agreement. Make sure to have a firm decision on UKRP ahead of UKCA marking, avoiding the expensive business of artwork updates, considering the addition of UKRP address on UKCA product.
10. Is the review of a product’s technical documentation a part of the UKRP Services offered by the prospect?
Since the UK MHRA requires the UKRP to keep a copy of the UK MDR compliant technical file and further requires reviewing the conformity assessment completed for the products. This is one of the reasons why the foreign manufacturers should appoint a third-party Regulatory service provider who has Regulatory know-how and technical knowledge to act as their UKRP instead of an importer or distributor.
Device manufacturers may obtain quotes from various service providers for UKRP representation of their devices. The quotes may vary significantly across different service providers. Though some cheaper quotes may sound luring, manufacturers must ensure they have these questions answered by their prospects. It would benefit the manufacturers to go with the prospect who justifies all these critical areas compliant.
Stay informed. Stay compliant.