With a Class III device, it was always clear that the design dossier had to be be submitted to and reviewed by the NB prior to certification. Over the years, I've gotten somewhat varied information about what happens with Class I devices that require NB oversight and with Class II devices. Now that the EU is transitioning from MDD to MDR, I thought I'd ask one more time:
What do you submit to an NB to support certification of a Class I or II device? What is the timing/chronology for submission, audit, certificate?
Will the answer to this question change under the MDR? If so, how?
What do you submit to an NB to support certification of a Class I or II device? What is the timing/chronology for submission, audit, certificate?
Will the answer to this question change under the MDR? If so, how?