Standards & Compliance: Updates on ‘Sustainable’ Medical Devices

Description: Sustainability is becoming an increasingly relevant criteria for gaining market access, driven by an heightened focus on the environmental impact of medical devices. This focus is driven by the need to safeguard public health by driving more environmentally sustainable manufacture, use and disposal of all medical devices. But the requirements for climate-neutral, energy-efficient, and resource-conserving business activities poses challenges for the medtech industry.
The European Green Deal represents comprehensive new regulations for climate and environmental protection at the European level. In addition, country specific regulations related to sustainability are starting to appear globally, including a proposed regulation currently in draft in the UK to support the NHS’s ‘Net Zero’ agenda.
Industry and governments globally are working to determine means of implementing various options that allow for more sustainable medical devices, from the mining of raw materials, through to production and distribution, and ultimately, more common practices such as recycling and greater use of eIFUs.
While it is clear that there is a high degree of interest in the topic of environmental sustainability, there is still a wide range of views on implementation. Some manufacturers are weary of new regulation in this area given that their products and practices are already subject to environmental regulation (for example, REACH, RoHS and carbon reporting) and there is a need to avoid setting duplicative requirements. There are also safety concerns from industry, noting that careful consideration should be given to the introduction of sustainability measures, with the safety of medical devices being paramount.

This session will discuss recent updates in EU and UK regulation of 'sustainable' medical devices and also look at what is ahead in the near future from 2023 onward. It will highlight any new implemented and upcoming requirements globally and discuss potential solutions and challenges for implementation from the NB perspective.