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 pleased to announce that the much-anticipated EU guidance on the regulatory pathway for Ethylene Oxide – when intended for the sterilisation of medical devices -has now been published. Attached to this email you will find a copy for your reference.
You can find it under the MDCG endorsed documents at the following link and under Borderline and Classification: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
Regulatory Status of Ethylene Oxide (EtO) for the Sterilisation of Medical Devices under “MDCG 2024-13 Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices”
This Medical Devices Coordination Group (MDCG) endorsed document establishes that EtO for sterilisation of medical devices is not itself a medical device (and thus is not required to be CE marked), but it is still in the scope of the MDR and IVDR. By extension, it is not in the scope of the EU Biocidal Products Regulation (BPR).
This is critical because, if under the scope of the BPR, the supply and use of this sterilant would eventually become banned in the EU.
Since at least 2019-2020, MedTech Europe has been working with its members, the EtO suppliers, plus various EU authorities (including the European Commission and the European Chemicals Agency) to avoid such a ban.
According to this MDCG guidance document, manufacturers of devices sterilised with EtO are required to address the sterilisation process and its validation within their Quality Management System, and they must also ensure compliance with the specific MDR and IVDR provisions regarding device sterilisation, particularly in Annex I (sections 11.2-11.6).
When EtO is used for sterilisation during the manufacturing of medical devices and IVDs, its application is regulated as part of the manufacturer’s sterilisation and validation procedures. These procedures are subject to the conformity assessment requirements of MDR/IVDR concerning the device being sterilised, without EtO itself requiring additional conformity assessments. The published MDCG 2024-13 guidance can be accessed via this link: Guidance on EtO Regulatory Status
Additionally, the MDCG 2022-5 rev.1 Guidance on Borderline between Medical Devices and Medicinal Products under Regulation (EU) 2017/745 has been updated to clarify that Ethylene Oxide is not classified as a medical device. Some references to products specifically intended for the cleaning, disinfection, or sterilisation of medical devices involving Ethylene Oxide have been removed (e.g., the use of ethylene oxide for endoscope sterilisation).
Please feel free to reach out if you would like any further clarification.
