European Commission
The article highlights the key points related to the manufacturers’ obligations in case of product supply being interrupted or discontinued.
EU
The new article provides an in-depth overview of the reporting requirements associated with performance studies involving in vitro diagnostic medical devices.
EU
The new article provides additional clarifications concerning the content of submissions associated with clinical investigations and modifications to it.
EU
The new article highlights the aspects related to the timelines associated with the clinical investigations, the way they should be calculated, and other relevant matters.
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