[Holly]

It’s interesting that you say that because I actually have successfully helped manufacturers of Class IIB and III implantable legacy devices satisfy the requirements for clinical data with retrospectively collected data via PMCF. BUT they were also legacy devices so it would not necessarily support a new product being brought to market under MDR – those will still be bound to the clinical investigation requirements. But there are many Class IIB implantable and III devices on the market that can successfully leverage retrospective data (of course depending on the targeted population, treated conditions, specific and measurable outcomes, etc).