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.


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