New Guidance on EtO in Medical Device Sterilization

The Medical Device Coordination Group (MDCG) has released a new guidance document, MDCG 2024-13, outlining the regulatory status of ethylene oxide (EtO) when used for sterilizing medical devices. Below is a summary of the key points covered in this guidance.

Purpose and Usage of EtO in Medical Device Sterilization

• • Purpose: This document clarifies the regulatory status of EtO used in sterilizing single-use medical devices during manufacturing under the Review Programme of Regulation (EU) 528/2012 on biocidal products (BPR). 

• • Usage: EtO is widely utilized in both large-scale industrial settings and smaller cartridges for health institutions to sterilize medical devices, in vitro diagnostic devices (IVDs), and medicinal products. 

Regulatory Status of EtO in Medical Device Sterilization

1. EtO Sterilization During Manufacturing 

• • Scope: EtO is essential in sterilizing medical devices and IVDs during manufacturing to ensure they reach the market in sterile condition. 
  • Quality Management: Manufacturers must manage and validate the EtO sterilization process as part of their Quality Management System (QMS), in line with standards such as: 

• • • EN ISO 13485:2016: Medical device QMS requirements.

• • • EN ISO 11135:2014 + A1:2019: Standards for developing, validating, and controlling EtO sterilization for healthcare products.

• • • EN ISO 10993-7:2008 + AC:2009 + A1:2022: Standards on EtO sterilization residuals in medical devices.

• • • EN 556-1:2024: Requirements for medical devices to be designated “STERILE.”
  • Regulatory Compliance: The use of EtO in manufacturing is regulated under the MDR and IVDR due to sterilization obligations. However, EtO itself is not classified as a medical device, placing it outside the scope of the BPR. 

2. EtO Use by Health Institutions 

• • Usage: Health institutions utilize EtO cartridges and related equipment to sterilize medical devices either before their first use or for reuse. 

• • Regulatory Scope: In this case, EtO cartridges and equipment are considered medical devices or accessories, falling under MDR regulations rather than BPR. 

EtO Sterilization: Regulatory Clarification under MDR and IVDR

This guidance clarifies that EtO, when used in manufacturing or by health institutions, is regulated under the MDR and IVDR, not the BPR. EtO cartridges used by health institutions are similarly classified under MDR. 

For the complete guidance, see the full MDCG 2024-13 document here. 

_____________________________________________

If you have questions about the new guidance on medical device EtO in sterilization regulations, our regulatory team is here to help—contact us for assistance.

Learn how MedEnvoy can assist you:

• • QMS Compliance Consulting
  • EU Authorized Representative
  • EU Regulatory Importer