This document provides essential clarifications regarding the regulatory framework for the use of EtO in the sterilization of medical devices and IVDs.
The guidance outlines that when EtO is used during the manufacturing process to sterilize medical devices and IVDs, its application falls under the MDR and IVDR. In these cases, EtO falls outside the scope of the Biocidal Products Regulation (BPR). Similarly, EtO cartridges used by health institutions to sterilize reusable medical devices are classified as medical devices or accessories under the MDR, which are outside the scope of the BPR.
Manufacturers are reminded of their responsibility to ensure compliance with the MDR and IVDR when employing EtO in sterilization processes. This includes adherence to harmonized standards, such as EN ISO 13485:2016 for quality management systems and EN ISO 11135:2014 + A1:2019 for sterilization procedures using EtO. These standards help ensure that sterilization processes are both safe and effective.
For further details, please consult the reference provided.