This is a very good question actually. Our NB asked for a separate stand-alone clinical evaluation plan even while still under MDD, but really it is only clear under MDR. If still under MDD, I'd be forever grateful to anyone who can help clarify/translate MDD for me. What are the units of the "clinical evaluation plan" ? [eg. one is written for the entire life cycle and is very generic; or is one written, based off a generic checklist SOP of the evaluation process, any time a triggering event-e.g.device mods, per 2 year schedule- occurs?]