Launch of Stakeholder Survey for the Medicines and Medical Devices Act 2021 by the MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health and Social Care have embarked on a review of the United Kingdom's medicines and medical device regulatory framework, aiming to modernise and improve the system to better protect patient safety, foster innovation, and accelerate access to cutting-edge medical technologies for the National Health Service (NHS).
The review, a statutory obligation under the Medicines and Medical Devices Act 2021, is being conducted in accordance with Part 6, Regulation 48 of the Act. The MHRA is collaborating with the Department of Health and Social Care (DHSC) in this endeavour, with Whitehouse Communications serving as an advisor to MedTech suppliers.
The primary objective of the review is to create a regulatory environment fit for the future, supporting the digital transformation of the NHS, shifting care closer to communities, and emphasising prevention over treatment. Key aspects of the review include:
1. Introducing international reliance routes to enable faster access to safe, effective medical devices already approved by trusted overseas regulators. 2. Making the UK Conformity Assessed (UKCA) marking procedure more focused on first-in-market innovations, including AI-based medical devices, while considering the removal of physical UKCA markings once unique device identification (UDI) is fully implemented. 3. Establishing a more risk-proportionate regulatory route for Class B in vitro diagnostic devices, reducing duplication and bureaucracy while maintaining safety standards. 4. Ensuring the MedTech sector contributes to the UK government's broader agenda of economic growth and NHS modernisation by streamlining market access and supporting innovation.
The review also aims to evaluate the current legislation's effectiveness in protecting public health and avoid imposing unnecessary or excessive regulatory burdens. The focus is on the legislation that governs the development, authorisation, supply, and oversight of medicines and medical devices in the UK. The review further considers the structure of the legislation for potential restructure or consolidation.
Stakeholders, including the Urology Trade Association, chaired by Chris Whitehouse, a political consultant who is an expert on medical technology policy and regulation, are encouraged to engage in this process. The MHRA seeks specific examples from stakeholders, particularly where change might be appropriate.
The online survey, available at the MHRA's website, is open until 19 September 2025. A downloadable version of the survey questions is also available. Questions or comments about the AI used in the preparation of the article can be directed to [email protected].
The completed survey findings will inform the Review, which will be published by the Secretary of State for Health and Social Care. The ultimate goal is to deliver legislative reforms that align with rapid technological advancements in medical devices, improve patient outcomes, and strengthen the UK’s position as a global leader in the MedTech industry.
- The Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health and Social Care are working together to modernize the United Kingdom's medicines and medical device regulatory framework, with the aim of fostering innovation and facilitating access to cutting-edge medical technologies for the National Health Service (NHS).
- The review of the regulatory framework, as mandated by the Medicines and Medical Devices Act 2021, will introduce international reliance routes, streamline the UK Conformity Assessed (UKCA) marking procedure, establish a more risk-proportionate regulatory route for Class B in vitro diagnostic devices, and streamline market access to contribute to the UK government's broader agenda of economic growth and NHS modernization.
- The review will also evaluate the current legislation's effectiveness in protecting public health and consider potential restructuring or consolidation of the legislation that governs the development, authorization, supply, and oversight of medicines and medical devices in the UK.
- Stakeholders, including the Urology Trade Association, are encouraged to engage in this review process, providing specific examples where change might be appropriate, and the completed survey findings will inform the publication of the Review by the Secretary of State for Health and Social Care, aiming to deliver legislative reforms that align with rapid technological advancements in medical devices, improve patient outcomes, and strengthen the UK’s position as a global leader in the MedTech industry.
