Launch of Stakeholder Survey for Medicines and Medical Devices Act 2021 by MHRA

Launch of Stakeholder Survey for Medicines and Medical Devices Act 2021 by MHRA

In a bid to improve patient access to innovative medical technologies, boost economic growth in the med tech sector, and reduce duplicative regulatory costs for manufacturers, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health and Social Care are conducting a comprehensive review of the UK's medicines and medical device regulatory framework. This review, a statutory obligation under the Medicines and Medical Devices Act 2021, is focused on modernizing the regulation of medical devices.

Key aspects of this review include:

• Introducing international reliance routes that allow faster market access for medical devices already approved by trusted regulators in countries like Australia, Canada, and the United States, thereby streamlining approvals.
• Consulting on the indefinite recognition of CE-marked medical devices for the UK market to help especially small and medium-sized enterprises (SMEs).
• Focusing the domestic UK Conformity Assessed (UKCA) route primarily on first-to-market innovative technologies, including medical devices incorporating artificial intelligence (AI).
• Removing physical UKCA markings once a unique device identification (UDI) system is implemented.
• Introducing a more risk-proportionate route to market for Class B in vitro diagnostic devices.

The review also overlaps with wider sector plans aiming to streamline adoption and procurement of medtech, including implementing rules-based pathways for medtech with reimbursement and support for proven innovations, launching a national NHS innovator passport by 2026 to reduce duplication in device evaluations and facilitate adoption, and piloting a 'HealthStore' marketplace in the NHS app for approved health digital products.

The regulatory review targets regulations under the UK Medical Devices Regulations framework governing devices in Great Britain, moving away from EU-based CE marking and enhancing international regulatory cooperation while fostering innovation particularly around AI and diagnostics.

Key regulations under review include:

• Routes to market approvals and recognition (CE mark indefinite recognition, UKCA marking)
• In vitro diagnostic device regulations (Class B devices)
• Post-market surveillance and reporting requirements
• Unique Device Identification (UDI) system implementation

These reforms aim to position the UK as a global leader in medical technology innovation while ensuring patient safety and quicker access to advanced devices.

The MHRA has opened a second round of applications for testing cutting-edge AI MedTech and encourages the sector to engage in this process. The agency is asking for specific examples, where possible, of cases where change might be appropriate.

The deadline for completing the questionnaire is 19 September 2025, and a downloadable version of the survey questions is available here. The findings from the completed survey will inform the Review and a report to be published by the Secretary of State for Health and Social Care. All feedback will be anonymised in the final report.

The online survey is available here.

[1] MHRA. (2022). UK MedTech Regulatory Review: Overview. Retrieved from https://www.gov.uk/government/publications/uk-medtech-regulatory-review-overview/uk-medtech-regulatory-review-overview

[2] Department of Health and Social Care. (2021). Accelerating Adoption, Access and Affordability: The Adoption Framework for Innovation in Health and Care. Retrieved from https://www.gov.uk/government/publications/accelerating-adoption-access-and-affordability-the-adoption-framework-for-innovation-in-health-and-care/accelerating-adoption-access-and-affordability-the-adoption-framework-for-innovation-in-health-and-care

[3] MHRA. (2022). MORE: The Medical Device and IVD Post-Market Surveillance System. Retrieved from https://www.gov.uk/guidance/more-the-medical-device-and-ivd-post-market-surveillance-system

[4] Medicines for Human Use (Clinical Trials) Regulations 2004

[5] Medicines and Medical Devices (Fees) Regulations

[6] Human Medicines Regulations 2012

[7] Medical Devices Regulations 2002

[8] The author of this article used AI in its preparation. Any comments or questions about the AI can be addressed to [email protected].

1. The recent review of the UK's medicines and medical device regulatory framework, led by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health and Social Care, is focused on modernizing the regulation of digital health, particularly medical devices that incorporate artificial intelligence (AI).
2. The review aims to streamline approvals for medical devices that have already been approved by trusted regulators in countries like Australia, Canada, and the United States, through the introduction of international reliance routes.
3. The MHRA is also encouraging the medical-conditions and health-and-wellness sector to engage in the process of testing cutting-edge AI MedTech and is requesting specific examples of cases where change might be appropriate.
4. The review overlaps with wider sector plans, aiming to foster innovation around AI and diagnostics, and positions the UK as a global leader in medical technology innovation while ensuring patient safety and quicker access to advanced devices, which is a topic of interest in policy-and-legislation and politics, and often features in general-news discussions.

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