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 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.
The article highlights the key points related to the manufacturers’ obligations in case of product supply being interrupted or discontinued.
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