Medical devices are categorized into four classes according to the EU Medical Device Directive (MDD) and its successor regulations. In general, medical devices with higher classes require the submission of more clinical data as supporting material. For high-risk devices, such as pacemakers or artificial joints, a full clinical assessment is required and the appropriate clinical evaluation report submitted.
As for the ethylene oxide sterilizer, it is a device used for sterilizing medical devices and is a low to medium risk medical device. Therefore, rigorous clinical evaluation and reporting is not normally required. However, the device needs to comply with relevant European Union standards and regulations to ensure its safety and effectiveness. For specific information on whether the device requires clinical evaluation, please consult the relevant technical expert or organization.