As I have stated previously, MDR does not define state-of-the-art or standard-of-care.
But it does mention state-of-the-art eleven times.
So how does MDR expect state-of-the-art to be part of the new regulation if it doesn’t clearly define what that is?
Good question. But hopefully this little video will help clear up some of the confusion: https://youtu.be/T1GS9WmkA_8