On 29 October 2024, the Medical Devices Coordination Group (MDCG) published the document ‘MDCG 2024-13 Regulatory status of ethylene oxide (EtO) for sterilisation of medical devices’.

This document addresses the application of EtO during the manufacture of medical devices and in healthcare institutions to sterilise devices before or after use.

The latest guidance document MDCG 2022-5 Rev. 1 is a key resource for stakeholders working under Regulation (EU) 2017/745.

Developed by the Medical Devices Coordination Group (MDCG) and approved by representatives from all EU Member States, these guidelines aim to clarify the sometimes nuanced distinction between medical devices and medicinal products.