The European Union's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) compliance deadlines are just around the corner. However, with the transition or ‘standstill’ period toward the new post-Brexit regime having started on January 1, 2021, medical device manufacturers also need to prepare for another set of regulatory requirements if they want to keep or introduce their products on the UK market.
The UK Medical Devices Regulations (UK MDR) 2002—not to be confused with the EU MDR—transposes the outgoing European directives for medical devices and in vitro diagnostic medical devices into UK law. Amendments to this regulation covered the UK’s departure from the EU. The significant milestone date in the amendments is June 30, 2023, when CE marks will officially stop being recognized in England, Scotland, and Wales (Great Britain). Until then, CE marked medical devices will remain applicable in Great Britain. Northern Ireland will continue to follow the EU's implementation timeline, meaning the EU MDR is now in force and the IVDR will apply following the 2022 deadline.
Continued availability of medical devices to UK healthcare services will depend on manufacturers keeping pace with multiple regulatory timelines. This article aims to identify key areas that companies need to prioritize, together with areas where new information may still emerge, in order to provide a starting point for businesses familiarizing themselves with UK Conformity Assessed (UKCA) marking requirements.
Making the Most of the Transition Period
Evaluating and Repurposing Compliance Efforts
The first thing to keep in mind is that the deadlines for registering high- and moderate-risk devices with the Medical and Healthcare products Regulatory Agency (MHRA) have already passed, in April 2021 and August 2021 respectively, while the deadline for low-risk devices is still to come in December 2021.
There are also some preliminary steps to be taken immediately, starting with a review of product portfolios and of the compliance effort that each product classification will require. To achieve compliance, each device classification will require a different degree of compliance effort, i.e., use of resources and financial investment. Given the time constraints and financial cost of achieving UKCA marking, manufacturers are advised to assess and compare compliance risk for each device, based on UK regional sales, classification, CE mark status, and preparation needed, in order to understand the effort required and review products portfolios accordingly. This preparatory work will help businesses to decide whether the pursual of the UKCA mark for all the product categories they currently supply to Great Britain continues to make sense from a commercial point of view.
For some manufacturers, this may prove to be a particularly good time to introduce a new product to the UK market, if, for example, the regulatory requirements for the product align with the existing compliance efforts. This may happen if preparations that have been underway to meet requirements for the EU MDR and IVDR can be repurposed for UKCA marking, thus allowing medical device companies to avoid duplication of efforts. Understanding the overlap between MDR/IVDR and UKCA requirements will also help to identify any gaps in data and documentation. In addition, given the fact that the UK MDR is based on previous European Medical Device Directives, manufacturers may find they have already or nearly met all the requirements, resulting in a reduced regulatory burden for certain devices. Therefore, it may be practical to start with these products to minimize unnecessary use of resources.
How Medical Device Companies Can Manage Relations with Representatives and Approved Bodies
Another key step of the preparation process for manufacturers based outside the UK is to appoint a UK Responsible Person (UKRP), registered with the MHRA. The UKRP’s name and registered place of business are required to appear on the device labeling, next to the UKCA mark. The UKRP is also responsible for registering the manufacturer’s medical devices with the MHRA. The requirements are different for Northern Ireland, where an EU Authorized Representative and an importer are still necessary for non-EU companies to support their conformity with the requirements of the EU MDR or IVDR.
As of January 1, 2021, UK Approved Bodies replaced the EU Notified Bodies when it comes to the conformity assessment for certain device classifications under the UKCA marking process. Currently, however, there are only three such organizations approved in the UK. Their capacity to review and approve technical documentation and the increase in submissions may result in delays in meeting demands.1 Manufacturers should start preparations accordingly, to account for possible delays and allow enough time to address and rectify any potential issues in their conformity assessment.
It is possible for businesses to initiate the process now by liaising with one of the listed Approved Bodies or reaching out to their existing EU Notified Body to find out whether they intend to become a UK Approved Body. More conformity assessment bodies are expected to enter the UKCA market in the future, so it would be prudent to monitor the list of UK Approved Bodies.
Keeping up with Changes and Developments
Following Brexit, EU-based companies as well as UK importers are likely to experience an increase in administrative tasks, especially the ones relative to import and export. At the end of the transition period, when the CE mark will no longer be recognized in the UK, there might be additional complications, so it is essential that all involved parties familiarize themselves with new procedures and controls and follow information from the relevant authorities in order to stay abreast of all developments.
The regulatory landscape is highly likely to further develop during the transition period as well. The MHRA is committed to addressing medical device safety concerns, such as those detailed in the Independent Medicines and Medical Devices Safety Review (also called the Cumberlege review).2 The UK is already planning to appoint a Patient Safety Commissioner (PSC), as the review recommends.
Data protection for ‘sensitive’ information moving between the UK and the EU is also almost inevitably evolving in the next few years—particularly considering any emerging tensions between UK data protection rules and the EU’s General Data Protection Regulation (GDPR). As of right now, both the EU and the UK seem to want to maintain ‘equivalency,’ but this issue will require close monitoring over time.
When planning and allocating resources, it is important that manufacturers do not neglect additional administrative tasks and data protection considerations and take into account the time needed to update and review the documentation internally as well as possible external delays, such as bottlenecks, once submitted. Companies that stay up to date with these developments and regulation changes, after the initial addition to their compliance and financial burden, will be likely to gain a competitive advantage in the UK market in the long-term.
- Gov.uk, Guidance: UK approved bodies for medical devices, Updated July 30, 2021.
- Independent Medicines and Medical Devices Safety Review, "First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review," July 8, 2020.