Data Collection Software Requirements Addressed in EU Medical Device Guidance

With one in four medical devices incorporating some form of medical device software (MDSW), the European Council’s Medical Device Coordination Group (MDCG) has issued a guidance on the regulatory pathway or conformity assessment for the hardware or hardware components that comprise these devices.

The eight-page guidance provides “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 is not a medical device or an accessory to a medical device. Clinical evaluation and cybersecurity for these products is not part of this guidance as these topics are covered in other guidances.

Read the guidance here.

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