DHSC Survey on Remanufacturing Class I Medical Devices

Overview

The Department of Health and Social Care (DHSC) is seeking industry feedback on the remanufacturing of single-use Class I medical devices. This initiative follows the publication of the DHSC’s ‘Design for Life’ Programme and the accompanying Design for Life Roadmap, which together set out a long-term vision for the UK health sector to move away from a linear, single-use model towards a circular economy for medical technology by 2045.

Regulatory Context

Currently, the Medicines and Healthcare products Regulatory Agency (MHRA) prohibits the remanufacture of single-use Class I general medical devices.

This position diverges from the regulatory approach in other jurisdictions including the United States, Australia, and Canada, and the DHSC is now exploring whether a similar approach could support the aims of the Design for Life Programme and help develop a circular economy for medical products in Great Britain.

A Design for Life

The Design for Life Programme and Roadmap aim to maximise the value of medtech products throughout their lifecycle including by reducing waste in the UK health sector, strengthening supply chain resilience, driving economic growth, and supporting the NHS’s net zero commitments. 

The Roadmap offers guidance to stakeholders across the UK health sector on areas where regulatory and policy change may be considered, including product design, supply chain practices, and the reuse of medical technologies. 

The Programme and Roadmap are highly relevant for organisations considering future compliance requirements and opportunities for innovation in the context of medtech, as stakeholders across the UK health sector are encouraged to engage with the policy at all levels. Examples of good practice may include:

• Engaging proactively with the DHSC and roadmap advisory groups;
• Reviewing procurement and supply chain strategies to identify opportunities for circularity;
• Investing in training and upskilling staff to support behavioural change; and
• Monitoring regulatory developments and participate in consultations to help shape the evolving framework.

Industry Survey

The DHSC’s survey is open to all manufacturers and remanufacturers of medical devices, regardless of whether they currently supply the domestic market. The Association of British HealthTech Industries has indicated that the survey will remain accessible until at least 31 October 2025.

The survey contributes to Action 17 of the Design for Life Roadmap, which is a priority action focussed on aligning the UK’s regulatory environment for circular Medtech with international standards. Results from this survey will subsequently inform the potential impacts, benefits, and risks of enabling remanufacture of Class I single-use medical devices in Great Britain. This evidence will be used to inform policy considerations regarding potential changes to the existing regulatory framework.

The DHSC has also indicated that, for the purposes of this survey, it is interested in feedback on the remanufacture of medical devices under UKCA marking for the Great Britain Market, as well as other relevant product markings used in other regions.

It is important to note that this exercise is not a formal regulatory consultation, and any subsequent review by the MHRA would be subject to the standard consultation process.

CMS Support

CMS has extensive experience advising life sciences and healthcare companies on regulatory compliance, product innovation, and market access in the UK and internationally. Our team can support organisations in interpreting new and emerging guidance, and advising on more specific queries such as the commercial and legal implications of remanufacturing single-use medical devices.  

We can also assist by supporting organisational supply chain strategy, procurement, and the integration of circular economy principles to ensure your business is well positioned for future regulatory developments and opportunities in the medtech sector.

For further information or to discuss how the Design for Life Roadmap may impact your organisation, please contact: Amélie Chollet, Hannah Curtis, and Sarah Hanson.