No, you just need to ensure that you use state of the art during design and development, as said above, - pre market activities.
Once on the market your post market activities demonstrate that your device remains safe and effective.
If anything in post market surveillance indicates that your device has problems then you would probably update the device and hence apply the current state of the art to your design change - pre market activities.
Once on the market your post market activities demonstrate that your device remains safe and effective.
If anything in post market surveillance indicates that your device has problems then you would probably update the device and hence apply the current state of the art to your design change - pre market activities.