The regulatory status of ethylene oxide (EtO) for the sterilisation of single-use medical devices during the manufacturing process has been discussed in relation to the Review Programme under Regulation (EU) 528/2012 on biocidal products (BPR).
Ethylene oxide (EtO) is used to sterilise a wide range of medical products, such as medical
devices, in vitro diagnostic medical devices (IVDs) and medicinal products, as well as products combining them. Sterilisation of products that are placed on the market in sterile condition is part of the manufacturing process and is usually carried out in large industrial units either by the manufacturers themselves or by external sterilisation service providers.
On a much smaller scale, EtO is also provided in cartridges for sterilisation of reusable medical devices, mainly in health institutions for use of such devices. Those EtO-containing cartridges, which are used for the supply of EtO to specific EtO sterilisers, are generally CE marked in accordance with the previous Directive 93/42/EEC or the current Regulation (EU) 2017/745 on medical devices (the ‘MDR’)…
