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.

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

Book a Consultation

GLOBAL BOTTOM CTA INSTRUCTIONS:

To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!