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  • Regulatory House

New general MDCG guideline Medical Device Software (MDSW)

The MDCG 2023-4 provides several examples to help determine whether or not the hardware and the software used with it can be considered medical devices. It does not focus on clinical evaluation or cybersecurity.

The guidance notes that in order for an MDSW to be classified as a medical device under the MDR, it must meet the definition of an intended medical purpose. If the MDSW and a hardware or hardware component qualify as a medical device or medical device component, the manufacturer of the MDSW must verify, validate, and demonstrate the safety, reproducibility, compatibility, and interoperability of the medical device or accessory to the medical device that the MDSW works in combination with, including all different configurations and variations as required by the MDR. This guidance can be found on the EC website:

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