MDCG 2023-4 Medical Device Software (MDSW) –Hardware combinations – October 2023

This guidance examines and clarifies the specific regulatory aspects that apply when the hardware or hardware component incorporating the data collection element (camera, electrical/optical sensors, etc.) is a medical device or an accessory to a medical device.
These guidelines also describe scenarios in which the hardware or hardware component incorporating a data collection element is not a medical device or accessory to a medical device. It is not the purpose of this document to develop aspects relating to the clinical evaluation or cybersecurity of these products, which are the subject of other guidelines.