MDCG 2023-4 addresses MDSW that cannot achieve its intended medical purpose without hardware or a hardware component, setting out three regulatory scenarios (desktop PCs and cloud platforms are out of scope): (1) the hardware qualifies as an accessory to the MDSW under MDR Annex VIII classification rules; (2) the hardware is placed on the market as a standalone medical device -- as part of a system (Art. 22), a combination (Art. 2(1)), or an integral component -- in which case the manufacturer may rely on the hardware's MDR conformity for general safety and performance requirements, though clinical evaluation must still cover the combined intended purpose; (3) the hardware is part of a general consumer or wearable product with no medical device/accessory status, in which case the MDSW manufacturer bears sole responsibility for the safety, performance and reproducibility of the combination across all supported configurations, with correspondingly broader post-market surveillance. Illustrative examples include dermal sensor patches and smartwatches (temperature, SpO2, heart rate) paired with a companion app.