Guide MDCG 2024-13: Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices

The MDCG has published a guide concerning the qualification of ethylene oxide (EtO) which led to the update of the guide MDCG 2022-5. The coordination group clarifies the regulatory status of EtO depending on the life cycle stage when the device is being sterilized.

EtO falls within the scope of Regulations (EU) 2017/745 and 2017/746 as a device or accessory of a device in the case where the device is intended to be sterilized by its end user. EtO will therefore be subject to a conformity assessment in its own right.

Eto, on the other hand, is not considered as such if the device is sterilized during the manufacturing process, before being placed on the market: “Its use is controlled as part of the sterilization and validation processes of the manufacturer.”

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