March 29, 2023
By Karen Hill
The UK’s Life Sciences Council recently provided an update to the Joint Statement on Medical Devices Regulatory Reform, which was originally published in December 2022, and established an Advisory Group to provide initial proposals to the government in three priority areas:
- International recognition;
- Routes for innovation; and
- System capacity.
Over the course of the last eight weeks, the Advisory Group agreed that there is a once-in-a-generation opportunity to make change, and agreed that their joint ambition is to make rapid and significant progress in the approach to these three areas. The resulting proposals have the potential to provide world-class support for innovators and best-in-class protections for patient safety.
Emergo by UL has summarized the highlights of the proposals below:
- Support and maintain the supply of safe medical devices to UK patients through expanded recognition (e.g., to US Food and Drug Administration (FDA) registrations) and removing burden where possible
- The UK seems to follow Switzerland in recognizing trusted jurisdictions such as the US and the EU. This allows manufacturers to access the UK, when leveraging EU or USA registrations and certifications.
- The UK Medicines and Healthcare products Regulatory Agency (MHRA) wants to become a more responsive regulator with supportive innovation pathways. But how?
- The MHRA’s role will be expanded and they will be directly involved in regulation of innovative devices.
- Introduction of a pre-market regulatory advice option for novel/innovative products.
- Expanding the use of real-world data enabling earlier access (under certain conditions).
- Establishing early engagement with innovators of novel products, building on the work already in progress to support innovation, including the progress made to date on the Innovative Devices Access Pathway and the AI Airlock for artificial intelligence.
- Enabling the future system, and avoiding current challenges through the development of a UK regulatory skill program
- Ensure there is sufficient regulatory expertise to support healthcare technology through the regulatory process, which should be shared between the public and private sectors.
As the reset proposals are significant, further detailed policy development and impact assessment are required; the Advisory Group set out their commitment to ensure momentum is maintained and the work needed to assess the aligned proposals is carried out and completed by the end of April. In addition, the MHRA will further develop and publish a roadmap setting out the regulatory infrastructure required to drive innovation and ensure patient safety.
Emergo by UL is part of the UK Responsible Person (UKRP) Association, and as such is closely involved in the latest regulatory updates. We will keep you informed of the further developments on the proposal.
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