Updated Notified Body Conduct Code Explains Permitted 'Structured Dialogue'

There is considerable focus at present on how far notified bodies can go in helping position their clients to have as smooth a conformity assessment passage as possible. It is a fine balancing act for all involved, but a new document gives useful insights.

Team-NB, the EU industry association for notified bodies, has issued the latest version of its code of conduct under the Medical Device Regulation (MDR) and the IVD Regulation for its members. This is the fifth edition.

One particularly interesting update to the document is a page citing what can be and cannot be provided in

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