N41 for the clinical evaluation of stand-alone software from the International Medical Device Regulators Forum (IMDRF) provide supporting information to all software developers. This is only guidance document and not a legal binding document.
What extent of data of medical devices from other manufacturers does needed to demonstrate equivalence? Annex XIV (3) EU MDR, for instance, refers to non-implantable devices of risk classes I – IIb. It specifies, that manufacturers must provide clear evidence that they have sufficient access to the data of the device with which they claim…Details