What should we do for the clinical development plan requirement for a legacy device? For example, if we don't plan to do a new clinical study for a legacy device that has no new risks that need to be addressed, what should be in the plan?

In MDCG 2020-6 guidance, it acknowledges that for a legacy device that's been on the market for a while, it's not appropriate to recreate the development plan because you've already been through that process. Instead, per the appendix to the guidance shows what you should have in lieu of having new clinical data, including a PMS plan.

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

Book a Consultation


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!