2023-10

MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations: Guidance on MDSW intended to work in combination with hardware or
hardware components.

This guidance intends to examine and provide clarifications on which specific regulatory considerations apply when the hardware or hardware component incorporating the data collection element (camera, electrical/optical sensors etc.) are a medical device or an accessory to a medical device. This guidance also outlines scenarios where the hardware or hardware component incorporating a data collection element are not medical devices or
accessories to a medical device. This guidance does not intend to elaborate on aspects related to the clinical evaluation or cybersecurity for these products, as those are tackled in other guidance.

The document can be downloaded in our library

Source: European Commission