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- there was already a pmcf but uh what under mdd when one was speaking under pmcf it was always
- study but before we can decide to have or not have a pmcf now we have to have a pmcf anyway
- yes so with a metaph22l one could assess whether one needed a pmcf study if you didn't have a pmcf
- if you didn't need a pmcf study then you were practically done with your pmcf activities
- on a pmcf for pmcf plan yes so the the minimum that is going to be probably accepted is uh
- pmcf plan and if there is no study needed seems to develop with pmcf kms plan so yes i think this is
- a pmcf also under ivdr i i think so yes but so is it called pmcf because it's not clinical or yeah
- knowledge to provide here so what we will do is that we try to focus on pmcf but uh what um we
- see where pmcf is on this cloud so we prepared just a slide that you send me a slide to show
- where i can say pmcf for all the other activities are so can you help us to
- it's something new but also the pmcf plan is slowly uh uh raising gaining importance uh
- something that's going to be audited uh well like a crcp now so maybe maybe a question so um pmcf
- that go beyond the study okay so this is the main difference yeah so um regarding the pmcf so mainly
- solomon so is the pmcf plan needed for a class one product yes so is this all dependent on class
- okay another question from salma is pmcf applicable to all medical devices or only medical
- devices that come into contact with the patient uh pmcf yeah plan and report you're gonna have it for
- marketing clinical app you need for every device okay um another one from anurag for how is pmcf
- study you would it's only part of the post-market clinical follow-up and not over of the pmcf uh so
- how is a pmcf study plan different from a pms plan than if it doesn't have to have a study and report
- how do you include surgical instruments class 1 air so orthopedic or spinal procedure in your pmcf
