EDA Guidance on Recalls: Initiation
The new article describes in detail how a recall action should be initiated, emphasizing the key points to be taken into consideration by the parties involved.
The new article describes in detail how a recall action should be initiated, emphasizing the key points to be taken into consideration by the parties involved.
The new article is dedicated to the rapid alert system implemented by the authority in order to ensure the important safety-related information associated with healthcare products allowed for marketing and use in the country is communicated and shared without undue delay.
The new article describes in detail the two subsequent stages of a recall process – implementation and review – and also highlights the key points to be taken into consideration by the parties responsible for a recall at each of the stages.
The article provides a general overview of the regulatory framework applicable to certain innovative products intended to be marketed and used in the UK.
The article provides a brief overview of a special regulatory framework introduced for certain in vitro diagnostic medical devices.
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