MDCG Guide 2024-13: What Medical Device Manufacturers Need to Know About Ethylene Oxide Sterilization

In the medical device industry, regulatory compliance is essential to ensuring patient safety. The MDCG Guide 2024-13, published on October 29, 2024, by the Medical Device Coordination Group (MDCG), provides critical clarification on the use of ethylene oxide (EtO) for sterilizing medical devices. This guide addresses many questions from manufacturers and healthcare professionals regarding best practices for EtO use in line with current European regulations, specifically the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).

EtO is one of the most commonly used sterilizing agents in the medical device industry, especially for heat-sensitive devices. However, its use presents significant challenges in terms of compliance and residue management, governed by strict standards, such as ISO 13485 for quality management systems, ISO 11135 for EtO sterilization validation, and ISO 10993-7 for ethylene oxide residue control.

The MDCG Guide 2024-13 not only clarifies manufacturers’ obligations but also specifies the contexts in which EtO must be used in compliance with MDR/IVDR. This includes details on manufacturers’ responsibilities within their Quality Management System (QMS) and requirements for technical documentation.

Providing a clear and precise framework, this guide helps manufacturers ensure the safety of their devices while meeting the regulatory expectations of the European Union. In this article, we will explore the requirements, applicable standards, and best practices for implementing the recommendations of MDCG 2024-13.

Overview of MDCG Guide 2024-13: Using Ethylene Oxide (EtO) in Compliance with MDR and IVDR

The MDCG Guide 2024-13 is a reference document published by the Medical Device Coordination Group to help medical device manufacturers navigate the regulatory requirements surrounding ethylene oxide (EtO) use in sterilization processes. Based on the European regulations MDR (EU Regulation 2017/745) and IVDR (EU Regulation 2017/746), this guide provides essential guidance for manufacturers and healthcare professionals on the safety and quality standards applicable to EtO.

The MDCG 2024-13 Guide highlights two main contexts of EtO use:

• Sterilization of medical devices during manufacturing: This use of EtO is governed by strict quality standards, such as ISO 13485, ISO 11135, and ISO 10993-7, to ensure that sterile medical devices are safe and meet European requirements.
• Use in healthcare facilities: EtO cartridges intended for sterilizing reusable devices in hospitals must comply with MDR standards, ensuring these devices are safe for prolonged medical use.

This guide also clarifies that, although EtO is used for sterilization, it is not classified as a biocide in this context. Sterilization processes within manufacturers’ Quality Management Systems (QMS) and governed by MDR/IVDR are excluded from the scope of the Biocidal Products Regulation (BPR).

By structuring these requirements and providing clear guidance, the MDCG 2024-13 enables manufacturers to better understand their responsibilities for technical documentation and validation of EtO sterilization processes. This contributes to the safety of medical devices throughout their lifecycle, from manufacturing to clinical use.

Implications of MDCG Guide 2024-13 for Medical Device Manufacturers: Compliance and Sterilization Management

For medical device manufacturers, the MDCG Guide 2024-13 is essential for understanding the responsibilities associated with ethylene oxide (EtO) use in sterilization processes. Detailing the regulatory requirements of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), this guide outlines the steps necessary to ensure the safety and compliance of sterilized devices.

Manufacturers must integrate several elements into their Quality Management System (QMS) to meet the expectations of MDCG 2024-13, specifically:

1. Sterilization Process Validation

EtO sterilization requires rigorous validation, in accordance with standards such as ISO 11135 (control of the sterilization process) and ISO 13485 (quality management systems). These standards ensure that processes are controlled and that devices are sterile and safe for patients.

2. Technical Documentation and MDR/IVDR Compliance

Technical documentation must include evidence of compliance with sterilization requirements. This involves incorporating validation reports, control procedures, and ethylene oxide residue data (as required by ISO 10993-7), ensuring that EtO residues remain below toxic thresholds.

3. Residue Monitoring and Control

Manufacturers are responsible for managing EtO residues post-sterilization, as specified in ISO 10993-7. This standard requires biocompatibility testing to ensure residue levels are safe for end-users and also recommends evaluating alternative sterilization methods when possible.

4. Continuous Evaluation and QMS Compliance

The guide encourages continuous evaluation of processes to ensure that sterilization remains effective and compliant with the latest regulatory requirements. This includes regular audits, updating technical documentation, and meeting traceability requirements, all covered within the QMS.

With these detailed requirements, the MDCG Guide 2024-13 provides manufacturers with a roadmap for comprehensive and secure EtO management in medical devices. Implementing these practices reinforces not only regulatory compliance but also patient safety, particularly for critical devices requiring reliable sterilization.

Key Standards and Requirements in MDCG Guide 2024-13 for Ethylene Oxide Sterilization of Medical Devices

The MDCG Guide 2024-13 provides precise guidance on the use of ethylene oxide (EtO) for medical device sterilization, focusing on the harmonized standards of MDR (EU Regulation 2017/745) and IVDR (EU Regulation 2017/746). These standards cover validation, residue control, and the necessary technical documentation to ensure the safety of EtO-sterilized devices. Here are the main standards cited and their implications for manufacturers.

1. ISO 13485: Quality Management Systems for Medical Devices

ISO 13485 serves as the foundation for the Quality Management System (QMS) for medical devices. It requires manufacturers to establish a rigorous quality process to ensure the safety and compliance of sterilized devices (sections 6.4, 7.5.5 et 7.5.7). In particular, this standard applies to sterilization processes, ensuring effective validation and regular compliance checks.

2. ISO 11135: Requirements for Ethylene Oxide Sterilization

This specific standard provides requirements for the development, validation, and control of EtO sterilization. ISO 11135 is essential for manufacturers using EtO in their processes, as it ensures sterilization is carried out under controlled, verified conditions, minimizing contamination risks.

3. ISO 10993-7: Evaluation of Ethylene Oxide Residues

ISO 10993-7 focuses on controlling EtO residues after sterilization. It establishes residue limits to ensure biocompatibility and patient safety. This standard also recommends evaluating alternative sterilization methods if residue levels pose toxic risks. Manufacturers must document residue test results and ensure devices are safe for use.

4. Technical Documentation and Traceability Requirements

The MDCG 2024-13 specifies that technical documentation must include detailed evidence of compliance with sterilization standards. This documentation covers EtO validation protocols, residue data, and risk assessments, all essential for ensuring traceability and compliance with MDR/IVDR requirements.

Through the rigorous application of these standards, the MDCG Guide 2024-13 provides manufacturers with a solid framework for EtO sterilization of medical devices, minimizing risks and ensuring patient safety. Adhering to these standards is crucial for regulatory compliance and maintaining optimal device quality and safety in the European market.

Considerations and Advice for Medical Device Manufacturers: Alternatives and Trends in Sterilization

In addition to providing a framework for EtO sterilization of medical devices, the MDCG Guide 2024-13 encourages reflections on optimizing sterilization practices and adopting new technologies. For medical device manufacturers, it is essential to assess not only current requirements but also emerging alternatives that could enhance safety and compliance.

1. Evaluating Alternatives to EtO Sterilization

In line with the recommendations of ISO 10993-7, manufacturers are advised to consider alternative sterilization methods to limit EtO residue exposure, especially when residues pose potential risks. Alternatives such as radiation sterilization and steam sterilization are often explored for certain types of devices. However, each method has its own validation requirements and may not be suitable for all devices.

2. New Technologies: Supercritical CO₂ Sterilization

An increasingly studied alternative is supercritical CO₂ sterilization, which combines aseptic properties without the toxic residues associated with EtO. This technology offers a promising solution for heat-sensitive devices and a better environmental profile by reducing emissions and chemical residues.

Currently, the AFNOR S95R commission is working to develop a dedicated standard for supercritical CO₂ sterilization, an equivalent to ISO 11135 but specifically adapted to this new technology.

CSDmed is an active member of this commission, participating in discussions and the development of this regulatory framework, which could transform the approach to medical device sterilization. As a commission member, CSDmed closely follows these developments and can provide up-to-date, accurate advice on this technology’s implications for manufacturers. Contact us for any information on supercritical CO₂ sterilization and learn how to anticipate future regulatory requirements to maintain a competitive edge and high safety standards in your processes.

Read our article on Supercritical CO₂ Sterilization.

3. Optimizing Sterilization Protocols and Quality Controls

To maximize safety and compliance, manufacturers can strengthen their sterilization protocols by integrating rigorous quality controls throughout the process. This includes initial validation, monitoring critical sterilization parameters, and conducting regular audits to ensure processes meet Quality Management System (QMS) requirements. Manufacturers may also benefit from automating monitoring processes to reduce human error and improve efficiency.

4. Anticipating Regulatory Changes

In a constantly evolving regulatory landscape, it is essential for medical device manufacturers to stay informed about new standards and guidelines. Actively participating in industry conferences, keeping up with publications from ISO and MDCG, and regularly consulting notified body opinions are all recommended practices for anticipating changes and adapting processes accordingly.

By adopting these best practices, medical device manufacturers can not only ensure compliance with the MDCG Guide 2024-13 and current regulations, but also position themselves as responsible and innovative players in the industry. Exploring alternatives and adapting to new technologies not only enhances patient safety but also improves manufacturing process efficiency.

MDCG Guide 2024-13 and Compliance for Medical Device Sterilization

The MDCG Guide 2024-13, published on October 29, 2024, represents a valuable support for clarifying the regulatory requirements surrounding the use of ethylene oxide (EtO) in the sterilization of medical devices. This document provides manufacturers with a comprehensive framework to ensure their products meet the highest safety and quality standards in line with the MDR and IVDR regulations.

To ensure compliance, medical device manufacturers must integrate key elements into their sterilization processes, such as process validation, residue control, and technical documentation. Harmonized standards, such as ISO 13485 for the Quality Management System (QMS), ISO 11135 for the EtO sterilization process, and ISO 10993-7 for residue management, form solid foundations for meeting regulatory requirements. The MDCG 2024-13 Guide also emphasizes manufacturers’ responsibility to monitor technological developments and consider alternatives such as supercritical CO₂ sterilization, which could enhance the safety and environmental impact of their processes.

Assistance and Compliance Consulting for Medical Device Sterilization

To help manufacturers align with best practices in sterilization and anticipate regulatory developments, our team of specialized consultants is ready to assist you. Whether it’s assessing your current compliance, optimizing your sterilization processes, or exploring alternatives suitable for your devices, we offer our expertise in MDR/IVDR compliance and quality management at your service.

🔗 Contact us for a personalized consultation and discover how we can help you navigate the complex regulatory framework of medical devices while ensuring the safety and quality of your products for patients.