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”.

The European Commission gives clarity on the regulatory status of EtO

EtO which is provided to for example healthcare institutions for sterilization of reusable medical devices, for specific EtO sterilizers are regulated by the Medical Devices Regulation (EU) 2017/745 (MDR) and not Regulation (EU) 528/2012 on biocidal products (BPR). These EtO cartridges, are in scope of the MDR “by virtue of falling under the definition of medical device, or accessory for a medical device, and therefore are outside the scope of the BPR as per Article 2(2)(b) BPR.”

The regulatory status of the EtO cartridges and sterilization equipment used for (re)sterilization of devices by healthcare institutes, is different from EtO used during the manufacturing of medical devices and IVDs. In the last case, EtO is controlled as part of the sterilization and validation process of the manufacturer, which is assessed by the Notified Body during to conformity assessment procedure about the device.

MDCG 2022 – 5 Rev. 1 Guidance on the borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices is changed accordingly.

Are you a manufacturer of devices used for cleaning and disinfecting medical devices? Note that this new MDCG guidance clearly states that the manufacturer should indicate that these devices are specifically intended for the disinfection or sterilization of medical devices. If this is not the case, and they appear to be multipurpose disinfectants the devices are not covered by the MDR, but the BPR.