New Guidance (MDCG 2024-13) on the Qualification of Ethylene Oxide for Medical Device Sterilization

An update from MedTech Europe on the newly published MDCG guidance mdcg 2024-13 regarding (Ethylene Oxide (EtO) used to sterilise MD and IVDs. It clarifies the status of EtO as not being under the Biocides Regulation (where it would have been banned), but falling under the MDR/IVDR, but not in itself being a medical device.   Dear Members, We are…