The European Union’s medical device (MDR) and In Vitro Diagnostic Regulation (IVDR) compliance deadlines are upon us. However, now that the transitional or ‘standstill’ period to the new post-Brexit regime has started on January 1, 2021, medical device manufacturers must also prepare for another set of regulatory requirements if they want to keep or introduce their products in 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. Changes to this regulation related to the UK’s departure from the EU. The important milestone date in the changes is June 30, 2023, when CE markings will no longer be officially recognized in England, Scotland and Wales (Great Britain). Until then, CE marked medical devices will continue to apply in Great Britain. Northern Ireland will continue to follow the EU implementation deadline, meaning the EU MDR is now in force and the IVDR will apply after the 2022 deadline.
Continued availability of medical devices to UK health services will depend on manufacturers keeping pace with multiple regulatory timelines. This article aims to identify the key areas for companies to prioritize, along with areas where new information could emerge, to provide a starting point for companies becoming familiar 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 yet to come in December 2021.
Some preliminary steps also need to be taken immediately, starting with an assessment of product portfolios and of the compliance efforts required by each product classification. To achieve compliance, each device classification requires a different degree of compliance, ie the use of resources and financial investment. Given the time constraints and financial costs involved in achieving UKCA marking, manufacturers are advised to assess and compare the compliance risk for each device based on regional UK sales, classification, CE marking status and required preparation, to determine the required effort to understand and assess product portfolios accordingly. This preliminary work will help companies decide whether pursuing the UKCA brand across all product categories they currently supply to the UK continues to make commercial sense.
For some manufacturers, this could prove to be a particularly good time to introduce a new product to the UK market, for example if the regulatory requirements for the product match existing compliance efforts. This can happen if preparations made to meet EU MDR and IVDR requirements can be reused for UKCA marking, helping medical device companies avoid duplication of work. Understanding the overlap between MDR/IVDR and UKCA requirements will also help identify any gaps in data and documentation. In addition, given that the UK MDR is based on previous European guidelines for medical devices, manufacturers may find that they have met all or almost all of 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 Relationships with Representatives and Approved Bodies
Another important step in the preparation process for manufacturers based outside the UK is the appointment of a UK Responsible Person (UKRP), registered with the MHRA. The name of the UKRP and registered place of business must appear next to the UKCA mark on the device labeling. The UKRP is also responsible for the registration of 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 required for non-EU companies to support their compliance with the requirements of the EU MDR or IVDR.
As of January 1, 2021, UK Approved Bodies have replaced the EU Notified Bodies when it comes to the assessment of conformity for certain device classifications under the UKCA marking process. However, there are currently only three such organizations recognized in the UK. Their ability to review and approve technical documentation and the increase in submissions can lead to delays in meeting requirements.1 Manufacturers should begin preparations accordingly to take into account possible delays and allow sufficient time to address and rectify potential issues in their conformity assessment.
It is possible for companies to start the process now by contacting one of the listed approved bodies or by contacting their existing EU Notified Body to find out if they are planning a UK based become an approved body. More conformity assessment bodies are expected to enter the UKCA market in the future, so it would be wise to check the list of UK approved bodies.
Keeping up with changes and developments
After Brexit, EU-based businesses and importers in the UK are likely to be given more administrative tasks, especially those related to imports and exports. At the end of the transition period, when the CE marking is no longer recognized in the UK, additional complications may arise, so it is essential that all parties involved familiarize themselves with new procedures and controls and the information provided by the relevant authorities to keep abreast of all developments.
The regulatory landscape will most likely continue to evolve during the transition period. The MHRA is committed to addressing the safety issues of medical devices, such as those described in the Independent Medicines and Medical Devices Safety Review (sometimes referred to as 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 will also change almost inevitably in the coming years, especially given any emerging tensions between the UK’s data protection rules and the EU’s General Data Protection Regulation (GDPR). At the moment, both the EU and the UK seem to want to maintain ‘equivalence’, but this issue will be closely watched over time.
When planning and allocating resources, it is important that manufacturers do not neglect additional administrative tasks and data protection considerations and consider the time required to update and review documentation internally, as well as possible external delays, such as bottlenecks, once they are submitted. Companies that stay abreast of these developments and regulatory changes are likely to gain a long-term competitive advantage in the UK market after first adding to their compliance and financial burdens.
- Gov.uk, Directive: UK Approved Medical Device Bodies, updated 30th July 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.