The article provides an overview of the regulatory approach to be applied with respect to certain categories of innovative medical devices.
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The Medicines and Healthcare products Regulatory Authority (MHRA), the UK agency in the sphere of medical devices, has published a guidance document dedicated to software and artificial intelligence (AI) as a medical device. The document highlights the key points regarding the applicable regulatory requirements, and also provides additional clarifications and recommendations to be taken into consideration by medical device manufacturers (software developers) in order to ensure compliance.
At the same time, the authority reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. First of all, the authority acknowledges that software, including artificial intelligence, plays a crucial role in health and social care.
In the UK, many such products are classified as medical devices or in vitro diagnostic medical devices (IVDs) and are, therefore, subject to regulatory oversight. The document provides an overview of regulatory guidelines and key outputs from the Software Group, which aims to support compliance and safety.
Innovative Devices: The Role of the Software Group
According to the guidance, the Software Group is responsible for ensuring the safety and regulatory compliance of Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD).
This objective is achieved through the following activities:
- Assisting manufacturers with pre-market and post-market regulatory inquiries.
- Conducting technical file reviews and post-market surveillance.
- Assessing clinical investigations and exceptional use authorisations.
- Ensuring medical device regulations remain fit for purpose and adaptable to software and AI advancements.
- Engaging with stakeholders, including healthcare professionals, industry representatives, and patients.
Classification of Software as a Medical Device or an IVD
In accordance with the applicable regulatory requirements, manufacturers and researchers must determine whether their software qualifies as a general medical device or an IVD based on regulatory guidelines. The Software Group is actively refining classification frameworks under the Software and AI as a Medical Device Change Programme Roadmap.
For those developing digital mental health technologies (DMHTs), additional regulatory guidance is available on device characterisation, qualification, and classification. Manufacturers should also review guidelines on in-house manufacturing and the Health Institution Exemption (HIE), particularly for Northern Ireland, as these considerations can impact regulatory status.
Additionally, the Software Group has provided specific guidance on software applications deployed during the COVID-19 pandemic.
UK Regulatory Framework for Software as a Medical Device
The MHRA has initiated an extensive change programme to reform the regulation of software as a medical device.
The key areas covered include:
- Qualification and Classification: Defining intended use statements to guide manufacturers in determining the medical purpose of software.
- Pre-Market Requirements: Ensuring SaMD products meet rigorous safety and efficacy standards before entering the market.
- Post-Market Surveillance: Establishing mechanisms for monitoring device performance, adverse events, and corrective actions.
- AI-Specific Challenges: Addressing transparency concerns related to AI explainability, interpretability, and adaptive learning.
The overarching goal of these reforms is to enhance the regulatory framework while keeping pace with technological advancements.
Software and AI as a Medical Device Change Programme Roadmap
On 17 October 2022, MHRA published the Software and AI as a Medical Device Change Programme Roadmap, which provides detailed objectives and deliverables. As new regulatory documents emerge, this roadmap will be updated accordingly.
Qualification and Classification Guidance
To assist manufacturers, the MHRA has provided guidance on crafting intended use statements, which clarify the purpose of software as a medical device. These statements help to ensure appropriate classification and regulatory compliance.
Post-Market Surveillance and Vigilance Reporting
Manufacturers are required to report adverse incidents and safety corrective actions related to SaMD.
Specific vigilance reporting guidelines outline:
- The types of adverse events that may cause harm and require reporting.
- The procedures for notifying MHRA about safety concerns.
- The use of the Yellow Card Scheme and the Yellow Card App for reporting software-related medical device issues.
Healthcare professionals in different UK regions have distinct reporting requirements:
- England and Wales: Reports should be submitted via the Yellow Card Scheme.
- Scotland: Reports should be made through NHS National Services Scotland’s online system and local incident recording platforms.
- Northern Ireland: Reports should be sent to the Northern Ireland Adverse Incident Centre and local reporting systems.
Artificial Intelligence in Medical Devices
With funding from the Regulatory Pioneers Fund, MHRA has conducted research in collaboration with Brunel University to assess methodologies for regulating adaptive AI medical devices. Between October 2021 and March 2022, a series of workshops were conducted, and findings were compiled into a final report.
However, these findings represent research outcomes and do not constitute MHRA policy.
MHRA, in partnership with the U.S. Food and Drug Administration (FDA) and Health Canada, has established regulatory principles for AI in medical devices:
- Good Machine Learning Practices (GMLP): Ten principles guiding AI/ML development.
- Predetermined Change Control Plans (PCCPs): Five principles ensuring international alignment on AI regulatory adaptations.
- Transparency Guidelines: Principles governing explainability and user interpretability of AI-enabled medical devices.
Digital Mental Health Technology (DMHT) Regulation
A three-year project, funded by the Wellcome Trust, is being led by MHRA to refine regulatory processes and evaluation frameworks for DMHTs. This initiative aims to improve safety, effectiveness, and compliance within the growing digital mental health sector.
International and National Collaborations
To enhance the regulation of software and AI in healthcare, the Software Group collaborates with various international regulatory bodies, academic institutions, and UK healthcare organisations.
Key partnerships include:
- International Medical Device Regulators Forum (IMDRF): Participation in working groups focused on SaMD and AI/ML-enabled medical devices.
- AI and Digital Regulations Service for Health and Social Care: Collaborative initiatives to advance AI oversight in medical applications.
- Wellcome Trust Project: A joint effort with NICE to evaluate digital mental health technologies.
- University of Birmingham’s STANDING Together Initiative: Researching AI and software regulation in healthcare.
- NHS England AI Award & DART-Ed Programme: Supporting AI innovation and education.
- Connected Medical Devices Security Steering Group: Ensuring cybersecurity for AI-powered medical devices.
Conclusion
In summary, software and AI play an increasingly critical role in healthcare, creating a need for stringent regulatory oversight to ensure patient safety and device efficacy. The change programme introduced by the MHRA is intended to modernise and align UK regulations with global standards while addressing the unique challenges posed by AI in medical applications.
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