By Ed Ball, RQM+
As medical device businesses work on complying with the EU’s Medical Device Regulation and In Vitro Diagnostic Regulation, they must now also turn their attention to changing regulatory rules in the U.K. The transition to the U.K.’s new regulatory regime has officially begun as of Jan. 1, 2021. All medical devices on the U.K. market must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA), including CE marked and U.K. Conformity Assessed (UKCA) marked devices, though there are grace periods for this initial registration based on the risk classification of a device.
During the transition period, the U.K. Medical Devices Regulations (U.K. MDR) 2002 will continue to apply in England, Scotland, and Wales, while CE marks will still be accepted up to June 30, 2023. Not to be confused with the EU MDR, the U.K. MDR transposes European directives for medical devices and in vitro diagnostic medical devices into U.K. law. In Northern Ireland, where the rules for placing a device on the market differ, the EU MDR and IVDR will apply in 2021 and 2022 respectively, in line with the EU’s implementation timeline.
Every business must begin planning now to make full use of the transition period and actively monitor for new developments. It is critical to understand where the U.K.’s regulatory regime is still a work in progress, where the potential areas of complexity lie, and any unknown factors. This article will highlight key actions that businesses must integrate into their planning to ensure continued access for their medical devices in the U.K.
1. Check For Overlap Between The U.K. and EU MDRs
The medical device industry is under a great deal of pressure due to the pandemic and regulatory deadlines, but their experiences with the MDR and IVDR may place them in good stead for this new compliance challenge. Businesses have already invested resources in complying with the MDR and IVDR, and so they must begin by determining whether their existing compliance efforts can be repurposed for UKCA marking. In this way, they can eliminate any unnecessary duplication of activities and then plan strategically to fill any gaps in data and documentation.
2. Consider Risk-Based Planning
This preparatory activity can help companies to make informed decisions about their product portfolios in the U.K. and EU markets, based on the level of compliance effort required for each device. Businesses should take a holistic view of regulatory requirements across their whole portfolio by building a risk matrix. The matrix should include products by geography, along with current level of preparedness. By building a complete picture of their regulatory status, companies can then analyze compliance effort and cost for each product class.
3. Rationalize Your Portfolio
A thorough assessment of the regulatory status within their portfolio should then help businesses review what their priorities should be, in line with their commercial interests. This means they may need to make decisions on whether to continue product supply or even introduce new products on the U.K. market. In some cases, the regulatory burden may be reduced, since the U.K. MDR is based on the EU directives, and not the recent EU MDR and IVDR. For instance, Class I devices that have been up-classified under the MDR may continue to self-certify for the U.K. market. It must be noted, however, that future U.K. legislation is likely to closely resemble the EU MDR and IVDR.
4. Engage Early With Approved Bodies
Many businesses may be tempted to wait until the middle or end of the transition period to begin their submission. Those devices that would previously have relied upon a Notified Body for their conformity assessment en route to a CE mark will require a conformity assessment by a U.K. Approved Body in order to attain their UKCA mark. As of January 1, U.K. organizations that were acting as Notified Bodies are now Approved Bodies; there are currently only three U.K. Approved Bodies. There is a danger that Approved Bodies may not be able to cope with demand for their services, so as with the MDR and IVDR, it is highly recommended that companies begin preparing as early as possible to enable easy access to an Approved Body and to ensure there is sufficient time to address any concerns.
5. Appoint A U.K. Responsible Person
Non-U.K. manufacturers must have a U.K.-based Responsible Person (UKRP), which is the new equivalent to the EU Authorised Representative. The UKRP must have a registered place of business in the U.K. in order to register with the MHRA and must be identified on either the device’s labelling or instructions for use (IFU) once the UKCA mark is affixed to the device. Only one UKRP may be appointed, contrary to the EU rules for Authorised Representatives. In Northern Ireland, non-EU businesses will still need a European Authorised Representative to market devices.
Businesses must first understand what will be expected of their representative, and then determine how to source a UKRP who will be able to reliably fulfil these requirements. Next, businesses must establish procedures for managing documentation with the responsible person, so that both parties have all the necessary information at hand and have clear communication channels.
6. Comply With Labelling And IFU Requirements
To comply with the new U.K. regulations, medical devices will need to bear a UKCA mark, as well as the name and address of the UKRP for non-U.K. based manufacturers. In Northern Ireland, medical devices must continue to have a CE mark or the UKNI mark in order to remain on the market. Transition to the MDR and IVDR requires many labelling changes, so it is important that manufacturers do not omit labelling updates from their planning and resource allocation.
7. Review Procedures For Conducting Clinical Investigations
Where investigations are based across multiple sites in and outside the U.K., businesses will need to plan how to implement and manage these investigations, in compliance with local requirements. Manufacturers with ongoing clinical trials in the U.K. must review the procedures for conducting investigations. It is likely that these will change as the MHRA develops its own requirements. The body has already published guidance on submitting safety reports, making substantial amendments to clinical trials, registering trials for investigational medicinal products, and publishing summary results.
8. Educate Yourself On Import/Export Management
Now that the U.K. is outside of the European Union, EU-based manufacturers and U.K. importers must ensure they are aware of new import procedures and controls and assess how this increase in administrative tasks may affect costs. While CE marking and certificates will continue to be recognized by the U.K. until June 2023, import/export administration thereafter may change considerably and become more complex and burdensome. Practical supply chain issues may emerge in practice. Close monitoring of the developing situation and the emerging intentions of the relevant regulatory authorities is essential.
9. Comply With Data Protection Requirements
Companies must put protocols in place to ensure compliance for the movement of protected data between the U.K. and the EU. Again, this is a situation whose outcome over the next few years is far from certain. The movement of any data that can be classed as “sensitive” is an issue, under the scrutiny not only of the medical device regulators but also subject to any emerging tensions between U.K. data protection rules and the EU’s General Data Protection Regulation (GDPR). So far, both the EU and the U.K. seem keen to maintain “equivalency,” as evidenced by the European Commission launching a process to adopt adequacy decisions of the U.K. for GDPR. This has to go through a number of further stages and requires close monitoring over time.
10. Take Into Account Developing Issues
As businesses begin UKCA submissions, it is likely that the MHRA will identify emerging issues or areas where further clarification is needed. Staying abreast of these developments will help companies learn from the experiences of others and avoid any potential issues in their own submission. As we have seen with the MDR and IVDR, regulations do not necessarily make it clear how requirements should be met, and so the guidance available from the MHRA is likely to evolve during the transition period.
For example, clarification will be required concerning the list of designated standards for medical devices issued by the U.K.’s Department for Health and Social Care. The published lists are based on the list of harmonized standards published in the Official Journal of the EU, which are only standards harmonized to the MDD, AIMDD, and IVDD. Recently published standards (e.g., ISO 14971:2019) have not been harmonized to the latter European directives and are thus not in the U.K.’s designated list, but they are considered as the state-of-the-art standards. Manufacturers will need to consider how to manage their compliance with applicable standards where different versions are cited in different regulatory jurisdictions.
The new regulatory regime is also an opportunity for the U.K. to address concerns relating to medical device safety, and this may impact the level of scrutiny during the approvals process. For instance, the Independent Medicines and Medical Devices Safety Review (or the Cumberlege review) was published in 2020, and it shone a light on how the English healthcare system had inadequately responded to serious safety concerns around three medical treatments. The report recommends that the MHRA strengthen adverse event reporting and medical device regulation, as well as improve engagement with patients and their outcomes. These recommendations will certainly play a part in revisions of U.K. legislation.
As the U.K. is likely to revise and update its own regulation for medical devices over the next few years, manufacturers will need to regularly review their compliance planning for products on the U.K. market. The pointers above serve to make the planning process as efficient as possible; manufacturers can make sure they are suitably prepared to work through each step, and they can also anticipate any delays along the way, such as finding a U.K. Responsible Person or carrying out administrative tasks for import. The task of attaining UKCA marking may also be facilitated by manufacturers’ efforts for EU MDR and IVDR, since data and documentation are likely to be more up to date than would have otherwise been the case. Those businesses that begin the submission process early are likely to lead the way for others, as well as avoid the risk of losing access to the U.K. market.
About The Author:
Ed Ball is a senior associate at RQM+. He formerly worked as a medical device specialist at the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), and is currently an active member of the U.K.’s Technical Committees for Medical Device Quality Management and Risk Management standards. He is a medical device specialist and chartered engineer who combines a technical understanding of medical devices with regulatory and quality management experience. Ed has more than 15 years of experience with devices that are EU Class I–III devices, active devices, implantable devices, diagnostic devices, measuring devices, and sterile devices.