EU
The article describes in detail the approach to be followed in order to determine the regulatory status and applicable regulatory requirements.
MDCG
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.
EU
The article provides a general overview of the regulatory approach to be applied with respect to certain CE-marked devices.
Bahrain
The article describes in detail the transitional arrangements associated with the recent regulatory changes in the European Union.
