MDCG 2023-4: Navigating the Intersection of Software and Hardware

The landscape of medical devices is evolving rapidly, with an estimated one in four devices incorporating or being medical device software (MDSW). This surge is driven by the integration of smart technology, from smartphones to wearable devices, transforming healthcare interactions for patients and clinicians alike.

Crucially, many MDSW solutions rely on hardware components like sensors and cameras to function effectively. Think of wearables like smartwatches or virtual reality goggles; they achieve their purpose by receiving and analyzing data from these components. The intricate interplay between MDSW and hardware raises questions about the regulatory pathways and conformity assessments for these integrated systems.

The recently released guidance by the Medical Device Coordination Group (MDCG), MDCG 2023-4, aims to shed light on these complexities. It delves into the nuances of when hardware components, incorporating data collection elements like cameras or sensors, qualify as medical devices or accessories. This distinction is vital in demonstrating conformity with regulatory requirements.

Importantly, the guidance provides clarity on scenarios where these hardware components might not fall under medical device regulations. While it doesn’t cover clinical evaluation or cybersecurity aspects, this guidance marks a significant step in ensuring the safe and effective integration of software and hardware in the dynamic realm of medical devices.

MDCG 2023-4