
MDCG Guidance on Ethylene Oxide (EtO)
The document provides an overview of the EtO regulatory status and highlights the key points to be taken into consideration by the medical device manufacturers utilizing it in their processes.
The document provides an overview of the EtO regulatory status and highlights the key points to be taken into consideration by the medical device manufacturers utilizing it in their processes.
The final article of the cycle highlights the key points related to certain specific product categories, outlining the most important aspects to be taken into consideration.
The article highlights the key points related to the regulatory status of in vitro diagnostic medical devices under the existing legal framework.
The new article describes in detail certain specific aspects to be taken into consideration by the parties involved in order to ensure the important information is duly communicated in accordance with the relevant regulatory requirements.
The new article provides additional clarifications regarding the specific scope of information-related obligations medical device manufacturers should comply with.