On October 29, 2024, the MDCG released guidance document MDCG 2024-13, clarifying the regulatory status of ethylene oxide (EtO) when used for sterilising medical devices. This guidance delineates the applicability of the MDR and the Biocidal Products Regulation (EU) 528/2012 (BPR) concerning EtO utilisation in medical device sterilisation processes.
Details of the Guidance MDCG 2024-13
The MDCG 2024-13 document addresses the regulatory considerations for EtO employed in sterilising single-use medical devices during manufacturing. It specifies that when EtO is used as part of the manufacturing process for medical devices and in vitro diagnostic medical devices (IVDs) intended to be placed on the market in a sterile condition, this use falls under the scope of the MDR and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). Consequently, such use is excluded from the BPR’s scope, as per Article 2(2)(b) of the BPR.
The guidance further elaborates that manufacturers must integrate the sterilisation process and its validation into their Quality Management System (QMS) in compliance with Article 10(9) MDR and Article 10(8) IVDR. This integration is detailed in harmonised standards, including EN ISO 13485:2016, which outlines requirements for regulatory purposes.
Additionally, the document highlights specific provisions within the MDR and IVDR that pertain to device sterilisation, such as:
- General safety and performance requirements in Annex I of both MDR and IVDR.
- Technical documentation requirements described in Annex II.
- Qualification criteria for notified body personnel as outlined in Annex VII.
- Conformity assessment procedures detailed in Annexes IX and XI.
By adhering to these provisions, manufacturers ensure that the use of EtO in sterilisation during manufacturing aligns with the regulatory obligations imposed by the MDR and IVDR.
Implications for Manufacturers and Health Institutions
For manufacturers, the guidance confirms that the use of EtO in the sterilisation of medical devices during production is regulated under the MDR and IVDR frameworks. This clarification assists manufacturers in aligning their sterilisation processes with the appropriate regulatory requirements, ensuring compliance and maintaining the safety and efficacy of their products.
Health institutions that utilise EtO and associated sterilising equipment for sterilising reusable medical devices, either before first use or after use to enable re-use, are also addressed in the guidance. The document provides insights into the regulatory status of EtO in these contexts, aiding health institutions in understanding their obligations under the current regulatory landscape.
Conclusion
MDCG 2024-13 offers essential clarification on the regulatory status of ethylene oxide used in the sterilisation of medical devices. By delineating the applicability of MDR, IVDR, and BPR, the guidance enables manufacturers and health institutions to ensure their sterilisation processes comply with the relevant regulations, thereby upholding the safety and performance standards of medical devices within the EU market.
For details, refer to the full MDCG 2024-13 document:
