Sponsored Presentation: Sustainability: potential challenges and solutions for the MedTech industry, Notified Bodies and auditing organizations.

Sustainability is becoming an increasingly relevant criteria for gaining market access, driven by a 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. However, the requirements for climate-neutral, energy-efficient, and resource-conserving business activities poses challenges for the MedTech industry.

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 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 the issue of sustainability and the potential solutions and challenges for implementation for the MedTech industry including recent updates in the global regulation of 'sustainable' medical devices and what is ahead. It will give a Notified Body and auditing organization perspective on sustainability including hybrid and remote audits.