
MDCG Revised Guidance on MDR Application for Legacy Devices
The article highlights the key points related to the regulatory status of legacy devices.
The article highlights the key points related to the regulatory status of legacy devices.
The new article provides additional clarifications regarding specific aspects of the regulatory approach to be followed.
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 final article of the cycle is dedicated to combination products and their specific regulatory nature.