[Emergo, UL] What the MDCG regulatory guidance document regarding ethylene oxide covers

It has caused years and years of regulatory uncertainty: Which EU law regulates ethylene oxide (EtO) used for sterilization of medical devices? At least for medical device and IVD manufacturers, this should be clear by now, with the publication of “MDCG 2024-13 Regulatory status of ethylene oxide (EtO) intended for the sterilization of medical  devices”.

 

 

What the MDCG document regulating sterilization chemical ethylene oxide covers | Emergo by UL

What the MDCG regulatory guidance document regarding ethylene oxide covers

---