Claire Burrows, Regulatory & Compliance Expert, Walker Morris02.03.23
After exiting the European Union (EU), the UK is now in a position where it must chart its own course for medical device regulations. In the autumn of 2021, the Medical and Healthcare Products Regulatory Agency (MHRA) consulted the UK government on how they believed these changes should look.
What Is the Background?
The MHRA consulted the government on their proposed changes to the medical devices regulatory framework. Namely, they were looking for views that would aid in the creation of new legislation to improve various areas of healthcare including:
- Patient safety
- More transparency in medical device information and the legislating process
- Greater alignment with international best practices
- A more dynamic and responsible approach to the regulation of medical devices
These views were collected from all areas of the healthcare spectrum to have as many voices as possible weighing in on the legislation process. Patients, developers, clinicians, and other healthcare professionals were consulted. The UK government recently published its response to this.
What the Government Had To Say
The MHRA were met with strong government support on a number of key proposals. On the issue of improving patient safety through regulation, the government said it would extend the reach of any laws around devices to select non-medical devices—like colored contact lenses and dermal fillers. Furthermore, greater post-market scrutiny would be applied to ensure any incidents are recorded and acted upon. They also committed to an improvement of device traceability; this would include the use of a Unique Device Identification.
The new framework will also champion diversity and the reduction of health inequalities, with manufacturers needing to prove their products can meet safety requirements across a diverse population. Further, the UK will align with international benchmark practices wherever standards are higher than the UK’s.
The new framework will also champion diversity and the reduction of health inequalities, with manufacturers needing to prove their products can meet safety requirements across a diverse population. Further, the UK will align with international benchmark practices wherever standards are higher than the UK’s.
Most Recent Updates
In an unexpected move, the MHRA confirmed on October 21, 2022, that a 12-month extension has been applied to the current standstill period for the future medical devices regime in the UK—until July 2024.
The regulations were initially due to come into force in July 2023; however, there was speculation the implementation date would have to be reconsidered due to a lack of evidence a robust framework could be achieved in the available timeframe.
It would appear the MHRA has also reached the same conclusion. Releasing a letter announcing the extension, the agency noted the importance of ensuring the future regime is “robust and reflects the detail required to avoid disruption to supplies, support innovation and enable safe access to Medical Devices for UK patients.”
The letter confirms that work to develop the regulations is ongoing with the next steps, namely to implement the transitional arrangements. These arrangements will commence when the new regulations come into force in July 2024, as well as post-market surveillance requirements, intended to be dealt with in legislation laid in Spring 2023. The MHRA stated, “Bringing into force the new post-market surveillance requirements ahead of the wider future regulatory regime reflects the high priority assigned to patient safety in the future framework.”
The MHRA’s letter also acknowledges the concerns about the capacity of the UK Approved Body (UKAB) system, which is currently made up of just five designated approved conformity assessment organizations, including the most recent addition—DEKRA. A UKAB is required to be involved in the substantial task of replacing CE marks with UKCA marks to signify conformity with the currently unknown UK regulations across all but the most basic of medical devices on the UK market. While the recently announced extensions mean UKCA compliance won’t be required until July 2024 (with the transition periods for CE marked devices to be UKCA marked starting at the same time), it is a relief the MHRA confirmed it is working proactively with six organizations that have applied to become UKABs, and several more that have expressed an interest.
The final paragraphs of the letter re-state the MHRA’s commitment to “prioritising and protecting patient safety,” signpost its latest Software and Artificial Intelligence as a Medical Devices Change Programme Roadmap (which forms part of their overall framework reform), and confirm guidance will be produced to support the interpretation of the future regulations.
The regulations were initially due to come into force in July 2023; however, there was speculation the implementation date would have to be reconsidered due to a lack of evidence a robust framework could be achieved in the available timeframe.
It would appear the MHRA has also reached the same conclusion. Releasing a letter announcing the extension, the agency noted the importance of ensuring the future regime is “robust and reflects the detail required to avoid disruption to supplies, support innovation and enable safe access to Medical Devices for UK patients.”
The letter confirms that work to develop the regulations is ongoing with the next steps, namely to implement the transitional arrangements. These arrangements will commence when the new regulations come into force in July 2024, as well as post-market surveillance requirements, intended to be dealt with in legislation laid in Spring 2023. The MHRA stated, “Bringing into force the new post-market surveillance requirements ahead of the wider future regulatory regime reflects the high priority assigned to patient safety in the future framework.”
The MHRA’s letter also acknowledges the concerns about the capacity of the UK Approved Body (UKAB) system, which is currently made up of just five designated approved conformity assessment organizations, including the most recent addition—DEKRA. A UKAB is required to be involved in the substantial task of replacing CE marks with UKCA marks to signify conformity with the currently unknown UK regulations across all but the most basic of medical devices on the UK market. While the recently announced extensions mean UKCA compliance won’t be required until July 2024 (with the transition periods for CE marked devices to be UKCA marked starting at the same time), it is a relief the MHRA confirmed it is working proactively with six organizations that have applied to become UKABs, and several more that have expressed an interest.
The final paragraphs of the letter re-state the MHRA’s commitment to “prioritising and protecting patient safety,” signpost its latest Software and Artificial Intelligence as a Medical Devices Change Programme Roadmap (which forms part of their overall framework reform), and confirm guidance will be produced to support the interpretation of the future regulations.
The Next Steps
Ultimately, tighter regulation to improve patient safety is a net benefit to all. However, businesses at all stages in the supply chain must be fully aware of their obligations to both ensure adherence to new standards and to maintain business traction during the transition. Being aware of and taking advantage of transitional arrangements must be a priority for businesses so that they have the maximum possible time to prepare for the changes.
Businesses exporting medical devices to both the UK and EU must take particular note of this. The decoupling of the UK from the EU’s regulatory orbit will require them to plan ahead if they wish to continue delivering products to both markets. Business leaders should draw up plans for a comprehensive compliance program that maintains adherence to both EU and UK frameworks.
The updates so far along with the government’s response has provided clarity on how medical devices will be regulated in the post-Brexit world, offering a more concrete framework for the regulation of the medtech and life sciences sectors.
With so little progress having been made to date, the initial deadline for implementation of the new regulations looming large, and the current political turmoil, the MHRA has taken the only sensible option in a bid to “provide additional time to develop the legislation and support system readiness.” We will have to wait to see if another 12 months will be enough time.
Claire Burrows is a specialist regulatory compliance lawyer at Walker Morris, a commercial law firm that provides tailored, long term, strategic advice to multinational companies and public and privately listed companies around the world. Burrows has expertise in health and safety, environmental, food safety, product safety, medical device regulation, Coronial Law, and anti-bribery legislation. She also regularly advises clients (both national and international), about regulatory compliance issues.
Businesses exporting medical devices to both the UK and EU must take particular note of this. The decoupling of the UK from the EU’s regulatory orbit will require them to plan ahead if they wish to continue delivering products to both markets. Business leaders should draw up plans for a comprehensive compliance program that maintains adherence to both EU and UK frameworks.
The updates so far along with the government’s response has provided clarity on how medical devices will be regulated in the post-Brexit world, offering a more concrete framework for the regulation of the medtech and life sciences sectors.
With so little progress having been made to date, the initial deadline for implementation of the new regulations looming large, and the current political turmoil, the MHRA has taken the only sensible option in a bid to “provide additional time to develop the legislation and support system readiness.” We will have to wait to see if another 12 months will be enough time.
Claire Burrows is a specialist regulatory compliance lawyer at Walker Morris, a commercial law firm that provides tailored, long term, strategic advice to multinational companies and public and privately listed companies around the world. Burrows has expertise in health and safety, environmental, food safety, product safety, medical device regulation, Coronial Law, and anti-bribery legislation. She also regularly advises clients (both national and international), about regulatory compliance issues.
