The regulatory status of ethylene oxide (EtO) for sterilizing single-use medical devices during manufacturing has been examined within the scope of the Review Programme under Regulation (EU) 528/2012 on biocidal products (BPR). EtO is widely used to sterilize various medical products, including medical devices, in vitro diagnostic medical devices (IVDs), medicinal products, and combination products. Sterilization for products marketed as sterile is typically a part of the manufacturing process and is often conducted in large industrial facilities, either by the manufacturers themselves or by external sterilization service providers.
On a smaller scale, EtO is also available in cartridges for sterilizing reusable medical devices, primarily within healthcare institutions. These cartridges, which supply EtO to dedicated EtO sterilizers, are generally CE marked under the former Directive 93/42/EEC or the current Regulation (EU) 2017/745 on medical devices (MDR).
The guidance can be accessed using the following link
