Regulatory Consideration for Software Hardware Medical Device

Lexology April 3, 2024
Sidley Austin LLP

Regulators are approving more medical device software (MDSW) every year (e.g., the U.S. Food and Drug Administration cleared 135 MDSWs in 2023, 56% more than 2022). One in four medical devices is estimated to be either MDSW themselves or contain medical device software. The Medical Device Coordination Group (MDCG) published guidance in October 2023 explaining the regulatory options available to manufacturers combining MDSW with hardware or hardware components. This post summarizes the key takeaways from the guidance.

Types of MDSW and hardware combination

It is commonplace for MDSW apps to receive and process data inputs from hardware or hardware components to produce a medical or therapeutic output. These hardware components can be external, providing input data to a MDSW app....

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