UK Law and Practice Contributed by: Amélie Chollet, Hannah Curtis and David Dennis, CMS
Overall, while the framework is robust, there is recognition that further updates and clarifica- tions are needed to keep pace with techno- logical advances and ensure proper regulation. Some of the issues to be aware of, which the government and regulators are actively working to address, are set out below. Ongoing Reforms The regulatory landscape is evolving, with new regulations planned to address emerging tech- nologies and clarify areas such as software as a medical device (SaMD) and cybersecurity. The MHRA is introducing changes to the MDR (GB) to address gaps and uncertainties, including regarding the regulation of SaMD. Gaps in Current Legislation Some areas, such as the regulation of AI/ML- enabled medical devices and cross-border digi- tal health services, are not yet fully addressed and may require further development. For exam- ple, the current medical devices legislation only regulates medical devices that are placed on the market or made available in the GB market. Therefore, a service provided from outside the GB market is arguably not regulated by current medical devices legislation even where it has a medical purpose. However, providing a ser- vice with a medical purpose from outside the GB market without it complying with medical devices legislation is not without risk, as this is a regulatory grey area and is also being consid- ered by the MHRA, with possible changes to the definition of “placing on the market” to provide clarity on the requirements that apply when soft- ware is provided online to the GB market. Even for areas that are regulated, there are often grey areas or uncertainty due to how quickly technology is progressing and new products being created. For example, classification and
regulation of digital health products, especially software, often requires case-by-case analysis due to the complexity and rapid evolution of technology. International Considerations Post-Brexit, there are differences between the GB and EU regulatory regimes (with the EU regulatory regimes applying in NI), particularly regarding CE marking and UKCA marking. GB continues to monitor and, where appropriate, align with international standards and defini- tions. 3. Regulatory Oversight 3.1 Oversight of Digital Healthcare In the UK, oversight of digital healthcare is shared among several bodies, each with distinct remits. The Medicines and Healthcare products Regulatory Agency (MHRA) The MHRA is responsible for regulating medi- cal devices, including digital health apps and software that qualify as medical devices, in GB (England, Wales and Scotland). Its remit includes ensuring that such products meet safety, qual- ity and performance standards, overseeing con- formity assessments, post-market surveillance and vigilance systems. The MHRA also regulates AI tools that diagnose, prevent or treat diseases. In NI, the MHRA also has limited regulatory func- tions, as medical devices are primarily regulated under the EU MDR framework through Proto- col arrangements. It is also worth noting that the MHRA has a role in regulating advertising of medicines and medical devices, notably as regards claims made to the general public.
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