MDCG Clarifies Ethylene Oxide Regulation Under MDR and IVDR
- Date
- October 31, 2024
- Category
EU Regulations
- Description
On October 29, the Medical Device Coordination Group (MDCG) issued a guidance document (MDCG 2024-13) clarifying the regulatory status of ethylene oxide (EO) under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in the European Union. Ethylene oxide is a commonly used sterilant for medical devices and is critical for ensuring the safety and effectiveness of various healthcare products.
Ethylene oxide is a gas used for sterilising medical and in vitro diagnostic devices, and combination products, as well as some reusable devices, that cannot withstand high temperatures or moisture. It effectively kills a broad spectrum of microorganisms and can penetrate small spaces, making it a preferred choice for sterilising complex devices, such as surgical instruments and implantable devices. However, EO is also classified as a carcinogen and poses health risks, necessitating strict regulatory oversight.
The MDCG's guidance outlines how EO is regulated under both the MDR and IVDR, notably how the use of EO must comply with the essential requirements of Annex I of the MDR requiring that devices must be designed and manufactured to ensure the health and safety of patients and users, and similarly in the IVDR where sterilisation methods are included in requirements for device safety and performance. Additionally, a comprehensive risk assessment is required by manufacturers when determining and using EO as a sterilisation method. Sterilisation validation is an essential part of a robust quality management system, as specified in ISO 13485:2016 and through incorporation of ISO 14971. Processes that are validated and in conformance with harmonised standards, such as EN ISO 11135 for EO, bear a presumption of compliance with the requirements of the EU Regulations.
Manufacturers must ensure they maintain regular monitoring and quality control measures are in place to ensure consistent sterilisation efficacy. Post-market surveillance (PMS) plays a vital role in ensuring ongoing compliance and the MDCG encourages manufacturers to implement effective PMS systems to monitor the performance of EO sterilized products, including the collection of data on any adverse events or incidents related to the use of these devices and conducting regular reviews of sterilisation practises and adjusting as necessary based on PMS findings. Resulting actions may also lead to updating risk management and quality assurance protocols and ensuring that staff are adequately trained on EO sterilisation processes and associated risks. The guidance also highlights the need for clear labelling, including the sterility assurance level (SAL) achieved, and information on the safe use of EO sterilized devices.
The MDCG's guidance on the regulation of ethylene oxide under the MDR and IVDR underscores the importance of safety in the sterilisation of medical devices. By clarifying the requirements, the MDCG aims to enhance patient safety while supporting manufacturers in navigating the complex regulatory landscape. Adhering to these guidelines will be crucial for maintaining compliance and ensuring the safe use of EO-sterilized medical devices in the EU market.