Competent Authority Notifications and the European Databank

The manufacturer, or his /her authorised representative, must inform the Competent Authority of  

In the case of IVDs that require the involvement of a Notified Body, data on performance characteristics, the results of performance evaluation and device certificates issued by the Notified Body must be included in the submission. The Competent Authorities are responsible for entering the following information in a European medical device databank, EUDAMED  

The manufacturer must also notify the Competent Authority of any significant modifications to devices, or discontinuance in the market. 

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