DHSC has published its Design for Life Industry Survey exploring remanufacture of Class I medical devices for members to provide feedback.
To recap the context, the survey is being conducted by the Design for Life programme at DHSC to explore the opportunities and implications of remanufactured single-use Class I medical devices for the GB market.
The Design for Life Roadmap highlighted remanufacture alongside reuse and recycling as a valuable approach to delivering a circular economy for medical products.
The Medicines and Healthcare products Regulatory Agency (MHRA) has set out its position on remanufacture of single-use medical devices in its 2016 guidance, which permits remanufacture of single-use medical devices of Class IIa upwards and committed to introducing regulation on this issue in the response to its 2021 consultation on future regulation of medical devices. But the current position remains to prohibit remanufacture of Class I general medical devices.
DHSC are aware of instances where Class I medical devices are permitted to be remanufactured in international jurisdictions including the US and Australia so are interested in whether enabling this in GB could better support a circular economy.
The findings of the survey will be shared with MHRA but note that this isn’t a consultation and any further review of the regulation by MHRA would be subject to the relevant requirements for consultation.
The survey does not currently have a definitive deadline, but will likely close in four weeks. Therefore, we recommend submitting responses no later than 14th August 2025.
