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The MHRA has opened its Consultation on the future regulation of medical and in vitro diagnostic devices (IVDs), which will run until 25 November 2021. The Consultation addresses the entire lifecycle of medical devices, as well as specific work packages on software as a medical device (including AI).

Below are 10 takeaways from the Consultation and work packages, focussing on (i) Software as a Medical Device (SaMD) and (ii) AI as a Medical Device (AIaMD). Medical device regulation in the UK is in a state of flux, but these may provide some clues on what UK regulators have in store for innovators in medtech:

1. Expect guidance, not a new legislative regime for SaMD: The MHRA anticipates that much of the change required specifically for SaMD will be in the form of guidance, rather than legislation. If legislative change is needed, this will build on the reforms to medical device regulation being consulted on as a part of the wider Consultation.
2. Defining software: The MHRA wants to ensure medical device regulations capture a sufficient breadth of software to protect patients and public. It is consulting on a proposed new definition of software ("a set of instructions that processes input data and creates output data") which is consistent with MEDDEV 2.1/6 Guidelines.
3. New classification rules? The MHRA has proposed changes to the classification of SaMD to more closely align with international practice. The proposal is to follow the risk categorisation in the IMDRF Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations, with minimal adaptations to suit the UK context. The MHRA acknowledges this will require updating the IMDRF SaMD category numbering (I, II, III, IV) to reflect the classification numbering for medical devices under the UK medical devices regulations (I, IIA, IIB, III) and adding classification implementation rules.
4. New (digital) frontiers for post-market surveillance: The MHRA intends to implement a system that allows adverse incidents to be captured more quickly for SaMD, including utilising real world evidence. One of the MHRA's proposals is that SaMD should have a hyperlink to MHRA endorsed websites where a person can report an adverse incident with a device. This would allow accurate and swift reporting via the Digital Yellow Card Scheme.
5. Minimum cybersecurity requirements: The MHRA wants to ensure SaMD has sufficient cyber security and information security for the purposes of (i) the direct safety of the device (for example, whether its functioning could be tampered with) and (ii) the security of personal data held on or in relation to the device. The MHRA is exploring minimum requirements relating to security measures and protection against unauthorised access.
6. SaMD Airlock - a new classification rule for innovative software: The MHRA is exploring the need for a temporary "airlock classification rule" to enable interim market access for novel and innovative SaMD, so that risk profile can be further studied and monitored. This would be likely to involve monitoring and restricting the SaMD as if it were a high-risk device, where the risk profile is unclear.
7. "Placing on the market" for Mobile Health, and Apps: SaMD can be deployed to the UK by websites, app stores and via other electronic means including deployment from websites hosted in other jurisdictions. The MHRA are considering whether the definition of "placing on the market" could be modified to clarify when SaMD deployed on websites, app stores (such as Google Play and Apple stores) and via other electronic means accessible in the UK should be considered "placing on the market".
8. AIaMD as a subset of software as a medical device: The above changes will apply equally to AIaMD, which the MHRA considers to be a subset of SaMD. The MHRA are considering other legislative changes specific to AIaMD, such as requiring performance evaluation methods for diagnostic AI which would take a comparable approach to the methods used for IVDs (in terms of demonstrating scientific validity, and analytical and clinical performance).
9. The unique challenges of AI (and introducing Project Rigour, Project Glass Box and Project Ship of Theseus: AIaMD poses unique challenges that the MHRA is proposing to address in concrete terms through three work packages:
   • Project AI Rigour: aims to ensure AIaMD is safe and effective through supplementary frameworks, with an emphasis on ensuring that AIaMD is fit for purpose for all populations in which it is intended to be used.
   • Project Glass Box (AI Interpretability): aims to develop frameworks regarding interpretability of AIaMD to ensure that AI models are sufficiently transparent to be robust and testable or are otherwise properly validated.
   • Project Ship of Theseus (AI Adaptivity): aims to articulate problems of fit with medical device regulation for adaptive AIaMD, distinguishing between models that are locked, batch trained, or continuously learning on streaming data. The MHRA intends to clarify how AIaMD of each type might fit within existing change management processes required by medical device regulations, and may craft new rules and guidance where needed.
10. What to expect in 2022 and 2023: The MHRA plans to deliver key elements of these work packages from Autumn 2021 until Summer 2023. We expect the dates for final deliverables may align with July 2023, when it is anticipated that the UKCA marking will become mandatory and EU CE marks will no longer be recognized in Great Britain. The MHRA will make further details on work packages and timelines available in the coming months.

With increasing complexities and constraints, it is important to have a robust regulatory strategy in place. A well-defined and dynamic regulatory strategy will open up multiple markets for your medical device, diagnostics, and digital health!

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