Do all residual risks identified need to be listed in your IFU and SSCP?

It's not feasible to identify and list all risks, but knowing where to draw the line can be difficult. Per the GSPRs, every residual risk should be listed. The notified bodies are using a pragmatic approach in assessing whether all of the important risks have been listed, but the interpretation can vary by notified body reviewer. In this video FAQ, our former notified body reps discuss factors if they considered and a couple examples.

 

 

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