MDCG 2023-4: Guidance on Medical Device Software (MDSW) – Hardware combinations

The Medical Device Coordination Group (MDCG) has published the MDCG 2023-4 guidance on MDSW intended to work in combination with hardware or hardware components.

As the latter play an essential role in contributing to the medical purpose of certain MDSW, it is important to consider how the manufacturers demonstrate their conformity to the applicable regulatory requirements.

This guidance intends to examine and provide clarifications on which regulatory considerations apply when the hardware or hardware component are a medical device or an accessory to a medical device. It also outlines scenarios where they are not qualified as such.

DOWNLOAD THE GUIDANCE MDCG 2023-4