Ed Ball, Senior Associate, RQM+09.10.21
The transition to the U.K.’s new regulatory regime officially began as of the first of January 2021. Medical device manufacturers are no newcomers to changing regulations, as they have been working toward EU MDR and IVDR compliance for quite some time. As they now turn their attention to the U.K., businesses will need to ensure all medical devices sold on the U.K. market are registered with the Medicines and Healthcare products Regulatory Agency (MHRA), including CE-marked and UKCA-marked devices. Although there are grace periods for this initial registration based on the risk classification of a device, it remains critical for manufacturers to act early to ensure their time to market is brief and they are not outpaced by the competition.
This new divergence between EU and U.K. requirements also means different rules apply to Great Britain (England, Scotland, and Wales) and Northern Ireland. 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. In Northern Ireland, where the rules for placing a device on the market differ, the EU MDR and IVDR will apply starting from 2021 and 2022 respectively, in line with the EU’s implementation timeline.
While the detail of the U.K.’s future regulatory regime is yet to be determined, clearly understanding transition periods, areas of application, and overlap between EU MDR and IVDR preparation and the emerging U.K. framework is key to rapid, effective compliance. There are 10 key elements that manufacturers would do well to check-list to ensure they are always fully under their control.
Overlap of Requirements
Medical device businesses have already invested a great deal of time and resources in complying with new regulations and are no newcomers to the process of updating procedures and documentation. Their experiences planning for EU MDR and IVDR compliance are a valuable asset because some of their existing compliance efforts may be repurposed for UKCA marking. Establishing whether this is possible is a first step in ensuring there is no duplication of efforts. It will then be possible to plan strategically to fill any gaps in data and documentation to improve efficiency.
1. Apply Risk-Based Planning
Different devices within a manufacturer’s portfolio will require different investments to bring them up to speed. Assessing the entire portfolio objectively on the basis of effort/value and compliance risk can help to decide which products are worth continuing to provide to the U.K. market and which would be best to simply withdraw. The matrix should include products by geography, along with current level of preparedness.
Assessing whether a product is worth putting through the compliance process to enter the U.K. market can also reveal whether the product is actually worth keeping on the market at all. Compliance can thus be a catalyst driving manufacturers to review their product portfolio in line with their priorities and commercial objectives.
This will lead to decisions on product supply but could also reveal that, in instances where the regulatory burden is reduced in the U.K. (since the U.K. MDR is based on the EU medical device directives, and not the recent EU MDR and IVDR), the U.K. becomes a more cost-effective market after all. Take, for example, Class I devices: some may have been up-classified under the EU MDR but the self-certification route remains for the U.K. market.
2. Engagement with Approved Bodies
Any U.K. organizations that were previously acting as Notified Bodies are now automatically U.K. Approved Bodies. At the time of writing, however, there are only three Approved Bodies to serve the entire U.K. market—one of which only has a restricted scope for IVD devices. It is evident this shortage in U.K. Approved Bodies could result in bottlenecks and slower times to market and could tempt manufacturers to wait until closer to the June 2023 transition deadline. Businesses would do well to engage with a U.K. Approved Body early rather than wait until the middle or end of the transition period to begin their submission.
3. Identifying a UKRP
A U.K.-based Responsible Person (UKRP) is required for all non-U.K. manufacturers. The role is akin to that of the EU Authorised Representative, but they must have a registered place of business in the U.K. in order to register with the MHRA. They will also be identified on either the device’s labelling or 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.
4. Working with Your UKRP
To establish a productive relationship with their UKRP, businesses must first understand what will be expected of their representative. Next, businesses must establish procedures for managing documentation with the responsible person so both parties have all the necessary information in hand and have clear communication channels.
5. Labeling and IFU Transition
Manufacturers that don’t want to be caught off-guard would do well to plan, resource, and schedule UKCA labeling and Instruction for Use (IFU) transition (earlier rather than later), bearing in mind that to comply with the new U.K. regulation, 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.
6. Managing Clinical Trials
Clinical investigations may take place across multiple sites, some of them in and some outside the U.K. Businesses will need to plan for multi-site clinical investigations, ensuring they follow local requirements for medical device clinical investigations. The MHRA has already published guidance documents on some aspects of the clinical trial process such as submitting safety reports, making substantial amendments to clinical trials, registering trials for investigational medicinal products, and publishing summary results.
7. Import/Export Admin
With the U.K. now outside the EU, U.K. manufacturers should have already invested resources into getting up to speed with export controls and documentation, as well as reviews of the related costs. For inbound products, practical supply chain and logistics issues may also emerge, making this a key area for attention.
8. Data Protection
Both EU-based and U.K. manufacturers will also need to monitor the status of data protection regulation closely. Although, at the moment, both the EU and the U.K. seem to be keen to maintain “equivalency” between the EU’s General Data Protection Regulation (GDPR) and U.K. data protection law, there are still a number of processes the European Commission needs to go through in its process to adopt adequacy decisions of U.K. for GDPR.
9. Ears to the Ground
In this dynamic environment, the MHRA will most likely continue to identify emerging issues or areas where further clarification is needed. Keeping on top of these developments is critical to ensuring successful entry into the U.K. market.
10. Opportunities Emerge
Finally, the new regulatory landscape poses a threat to the efficiency of processes that were already under pressure from the effects of the pandemic and efforts to comply with EU MDR and IVDR, but it is also rich with opportunity. On the one hand, the U.K. has the chance to tackle issues concerning patient safety such as those highlighted in the Cumberlege review; on the other, businesses have the chance to leverage efficiencies in their compliance processes where there is overlap and to strategically revaluate their portfolio of products.
Ed Ball 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 an accomplished medical device specialist and chartered engineer who combines a technical understanding of medical devices with regulatory and quality management experience. Ball has more than 15 years of practical experience with a wide breadth of medical devices, including but not limited to EU Class I to III, active devices, implantable devices, diagnostic devices, measuring devices, devices used by lay people, and sterile devices.
This new divergence between EU and U.K. requirements also means different rules apply to Great Britain (England, Scotland, and Wales) and Northern Ireland. 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. In Northern Ireland, where the rules for placing a device on the market differ, the EU MDR and IVDR will apply starting from 2021 and 2022 respectively, in line with the EU’s implementation timeline.
While the detail of the U.K.’s future regulatory regime is yet to be determined, clearly understanding transition periods, areas of application, and overlap between EU MDR and IVDR preparation and the emerging U.K. framework is key to rapid, effective compliance. There are 10 key elements that manufacturers would do well to check-list to ensure they are always fully under their control.
Overlap of Requirements
Medical device businesses have already invested a great deal of time and resources in complying with new regulations and are no newcomers to the process of updating procedures and documentation. Their experiences planning for EU MDR and IVDR compliance are a valuable asset because some of their existing compliance efforts may be repurposed for UKCA marking. Establishing whether this is possible is a first step in ensuring there is no duplication of efforts. It will then be possible to plan strategically to fill any gaps in data and documentation to improve efficiency.
1. Apply Risk-Based Planning
Different devices within a manufacturer’s portfolio will require different investments to bring them up to speed. Assessing the entire portfolio objectively on the basis of effort/value and compliance risk can help to decide which products are worth continuing to provide to the U.K. market and which would be best to simply withdraw. The matrix should include products by geography, along with current level of preparedness.
Assessing whether a product is worth putting through the compliance process to enter the U.K. market can also reveal whether the product is actually worth keeping on the market at all. Compliance can thus be a catalyst driving manufacturers to review their product portfolio in line with their priorities and commercial objectives.
This will lead to decisions on product supply but could also reveal that, in instances where the regulatory burden is reduced in the U.K. (since the U.K. MDR is based on the EU medical device directives, and not the recent EU MDR and IVDR), the U.K. becomes a more cost-effective market after all. Take, for example, Class I devices: some may have been up-classified under the EU MDR but the self-certification route remains for the U.K. market.
2. Engagement with Approved Bodies
Any U.K. organizations that were previously acting as Notified Bodies are now automatically U.K. Approved Bodies. At the time of writing, however, there are only three Approved Bodies to serve the entire U.K. market—one of which only has a restricted scope for IVD devices. It is evident this shortage in U.K. Approved Bodies could result in bottlenecks and slower times to market and could tempt manufacturers to wait until closer to the June 2023 transition deadline. Businesses would do well to engage with a U.K. Approved Body early rather than wait until the middle or end of the transition period to begin their submission.
3. Identifying a UKRP
A U.K.-based Responsible Person (UKRP) is required for all non-U.K. manufacturers. The role is akin to that of the EU Authorised Representative, but they must have a registered place of business in the U.K. in order to register with the MHRA. They will also be identified on either the device’s labelling or 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.
4. Working with Your UKRP
To establish a productive relationship with their UKRP, businesses must first understand what will be expected of their representative. Next, businesses must establish procedures for managing documentation with the responsible person so both parties have all the necessary information in hand and have clear communication channels.
5. Labeling and IFU Transition
Manufacturers that don’t want to be caught off-guard would do well to plan, resource, and schedule UKCA labeling and Instruction for Use (IFU) transition (earlier rather than later), bearing in mind that to comply with the new U.K. regulation, 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.
6. Managing Clinical Trials
Clinical investigations may take place across multiple sites, some of them in and some outside the U.K. Businesses will need to plan for multi-site clinical investigations, ensuring they follow local requirements for medical device clinical investigations. The MHRA has already published guidance documents on some aspects of the clinical trial process such as submitting safety reports, making substantial amendments to clinical trials, registering trials for investigational medicinal products, and publishing summary results.
7. Import/Export Admin
With the U.K. now outside the EU, U.K. manufacturers should have already invested resources into getting up to speed with export controls and documentation, as well as reviews of the related costs. For inbound products, practical supply chain and logistics issues may also emerge, making this a key area for attention.
8. Data Protection
Both EU-based and U.K. manufacturers will also need to monitor the status of data protection regulation closely. Although, at the moment, both the EU and the U.K. seem to be keen to maintain “equivalency” between the EU’s General Data Protection Regulation (GDPR) and U.K. data protection law, there are still a number of processes the European Commission needs to go through in its process to adopt adequacy decisions of U.K. for GDPR.
9. Ears to the Ground
In this dynamic environment, the MHRA will most likely continue to identify emerging issues or areas where further clarification is needed. Keeping on top of these developments is critical to ensuring successful entry into the U.K. market.
10. Opportunities Emerge
Finally, the new regulatory landscape poses a threat to the efficiency of processes that were already under pressure from the effects of the pandemic and efforts to comply with EU MDR and IVDR, but it is also rich with opportunity. On the one hand, the U.K. has the chance to tackle issues concerning patient safety such as those highlighted in the Cumberlege review; on the other, businesses have the chance to leverage efficiencies in their compliance processes where there is overlap and to strategically revaluate their portfolio of products.
Ed Ball 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 an accomplished medical device specialist and chartered engineer who combines a technical understanding of medical devices with regulatory and quality management experience. Ball has more than 15 years of practical experience with a wide breadth of medical devices, including but not limited to EU Class I to III, active devices, implantable devices, diagnostic devices, measuring devices, devices used by lay people, and sterile devices.
