MDCG 2024-13: Regulatory Status of Ethylene Oxide (EtO) Intended for the Sterilisation of Medical Devices
8 November 2024
The Medical Device Coordination Group (MDCG) recently published guidance MDCG 2024-13 on the regulatory requirements for ethylene oxide (EtO) used for sterilisation of medical devices (MDs), in vitro diagnostics (IVDs) or medicinal products.
EtO is a substance used in the manufacture of MDs or IVDs to achieve sterile conditions. According to Article 10(9) MDR and Article 10(8) IVDR, EtO sterilisation procedures and their validation must be addressed by manufacturers in the quality management system, but no additional conformity assessment is required.
In general, the regulatory status of EtO used for sterilisation of single-use medical devices during the manufacturing process has already been discussed in the Biocidal Products Review Programme (BPR) under Regulation (EU) 528/2012. However, due to the fact that several provisions of the MDR and IVDR address EtO sterilisation, it falls under their regulatory obligations. This means that EtO falls within the scope of the MDR and IVDR, although it does not fall within the definition of a medical device, accessory or IVD.
There is one exception where EtO must undergo an additional conformity assessment, for example where EtO and associated sterilisation equipment are used in healthcare facilities to sterilise a medical device before or after use so that it can be re-used. EtO cartridges used for sterilisation are then covered by the MDR/IVDR and need a separate assessment.
In summary, EtO is no longer within the scope of the BPR, but the use of EtO is subject to the MDR/IVDR, although EtO as a substance itself does not require additional MDR/IVDR conformity assessment. It should be noted, however, that the there is an example of a case in where EtO requires a separate conformity assessment.
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