The Secretary of State intends to create a thriving ecosystem for innovation using a regulatory approach as a key tool. This would be the first of its kind as regulations and regulatory frameworks often follow new technologies placed in the market. Understanding the dynamic complexity of the system and the interaction of the systematic elements often goes beyond the scope of regulators and policymakers but it is key to driving innovation and the accessibility of it in the market.
The proposal to establish a pro-innovation framework requires a risk-based approach to avoid unnecessary barriers to entering the market. One of those barriers can be reduced by utilizing mutual recognition. The Government’s response to consultation on the future regulation of medical devices includes the option for a domestic assurance route and shows that there is room for mutual recognition with other competent authorities. For example, this allows UK Approved Bodies to adopt an abridged assessment and hopefully reduces the review lead time ensuring rapid market access to new technologies.
The approval process may become even more dependent on other market approvals when clear guidelines are set. It is important for manufacturers to understand the process and what it means for the technical documentation of a device if this pathway is recognized. Can the technical documentation be leveraged from the other market’s approval? Which additional documents must be prepared for the UK market? The recognition of internal standards and clinical data-collection pathways play a crucial role. When there is an increase in compatibility, a consistent degree of innovation can be stimulated. The framework should aim for an evidence-based approach proportionate to the risks.
With the introduction of artificial intelligence in the medical device and in vitro diagnostic sector years ago, the MHRA has now launched a Software and AI as a Medical Device Change Programme and proposed changes to the framework¹. The purpose is to ensure regulatory requirements provide a high degree of assurance that devices are acceptable safe and function as intended². Moreover, the UK identified that AI can be used in such a way that it helps manufacturers to get novel devices to the market faster. These are measures considered to strengthen the position of digital technologies in fostering patient care.
All in all, the pro-innovation framework is to be designed in such a way that safety and performance are at the core while the quality of life for patients improves. The direction of travel in the UK shows that innovation, resources, and stability as a future system are at its core³. The current situation creates both opportunities and threats for manufacturers and it is, therefore, important to track how this evolves.
 Government response to consultation on the future regulation of medical devices
 Policy Paper: Establishing a pro-innovation approach to regulating AI UK Advisory Group Reform Proposals