UK medicines and medical devices regulator, the MHRA, has set out plans for an extension to the timetable for changes to the rules applicable to medical devices. New regulations were planned to take effect in mid-2023, with an extensive consultation process carried out over the past year to gather input on the proposals. However, the bulk of these changes can now be expected to take effect a year later, in mid-2024.
The MHRA has recognised the difficulties businesses face in achieving and demonstrating compliance, particularly in light of restricted capacity among Approved Bodies. These organisations, who are involved in the conformity assessment process for medium and high risk products, must be approved for designation before they can act. Several more Approved Bodies are expected to receive designation status shortly and join the four already available to support UK conformity assessment.
In light of these changes, we expect to see the MHRA’s guidance updated shortly, and this is likely to include an extended period for reliance on CE marking.
Software and Artificial Intelligence as Medical Device Change Programme - Roadmap
The MHRA has also published a Roadmap on how changes to the regulatory framework for software and AI medical devices will be put in place. Building on the work of the recent consultation, we can expect to see some legislative changes. However, a substantial part of the proposals will be brought into effect using guidance. The topics addressed are:
- WP 1 Qualification: emphasising the need for both clarity and flexibility on what falls within medical device regulation, and clarifying the identity of the manufacturer
- WP 2 Classification: working to ensure that risk is appropriately reflected in classification and conformity assessment. Closer alignment with international standards (IMDRF Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations) is planned, along with an ‘airlock process’ (or regulatory sandbox) for SaMD where this is necessary to generate real world evidence.
- WP 3 Premarket requirements: tailoring the essential requirements for software and AI so that they align better to these technologies and with international standards.
- WP 4 Post Market: to ensure that safety signals are captured more quickly and comprehensively, and to deal with change management over the life of the product.
- WP 5 Cyber Secure Medical Devices: to address and deal with risks arising from connectivity inherent in AI and software devices.
- WP 9 AI RIG (AI Rigour): working collaboratively with international groupings to deal with the specific challenges presented by AI devices.
- WP 10 Project Glass Box (AI Interpretability): addressing the ‘black box’ problem and promoting human interpretability.
- WP 11 Project Ship of Theseus (AI Adaptivity): dealing with changes over time and what processes can be used to ensure ongoing safety and effectiveness.
With these plans, and those set out in the wider consultation, there is a substantial programme of work under way to create a medical device framework that is fit for the future. We will monitor these changes as they progress.
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