On October 29, 2024, EU MDCG (Medical Device Coordination Group) published guidance MDCG 2024-13 to provice clarity on the regulatory status of ethylene oxide (EtO) for the sterilization of medical devices.
EtO is used for sterilizing a variety of products, including medical devices, in vitro diagnostic medical devices (IVDs), and pharmaceuticals.
The regulatory status of EtO for the sterilization of medical devices is as follows:
Sterile medical device manufacturers must address the sterilization process and its validation as part of their quality management system (QMS) according to Article 10(9) MDR and Article 10(8) IVDR, which are outlined in the requirements for regulatory purposes in EN ISO 13485:2016 – Medical devices – QMS.
In addition, several provisions of the MDR and IVDR address sterilization of medical devices:
1) The general safety and performance requirements in Annex I of the MDR/IVDR (see sections 11.3-11.6 and 11.2-11.4), which include:
- EN ISO 11135:2014 +A1:2019: Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices,
- EN ISO 10993-7:2008 +AC:2009 +A1:2022: Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals,
- EN 556-1:2024: Sterilization of medical devices – Requirements for medicaldevices to be designated “STERILE” – Part 1 : Requirements for terminally sterilized medical devices
2) the technical documentation described in Annex II MDR/IVDR
3) the qualification requirements of notified body personnel laid down in Annex VII (sections 3.2.1 and 3.2.5)
4) the conformity assessment procedures laid down in Annex IX and XI MDR/IVDR (e.g. Annex IX, section 2.2 and 3.2 respectively)
The guidance clarifies that EtO and other sterilization equipment can be used for sterilizing medical devices either before first use of for reuse. In this case, the EtO cartridges used for sterilization are considered to fall under the definition of medical devices or accessories for medical devices, thus falling within the scope of the MDR and outside the scope of the biocidal products regulation (BPR) (EU) 528/2012.
Please refer to the attached document below.
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