Change is on its way – medical devices law will not be the same again as of next year.
The authorities are not your friend anymore.
Notified bodies are engaging in massive ‘panic soccer’ (Dutch expression) dropping companies like they’re hot.
If you have not implemented the new clinical evaluation MEDDEV fully by now this should have your utter undivided attention. Otherwise, count on your CE certificate for the device(s) affected being suspended without warning after t [...] « Read the rest of this article on