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MDCG 2023-4 – Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components

The guidance intends to examine and provide 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.

Read the news announcement published by EC Directorate-General for Health and Food Safety on 18 October 2023.


OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (12 février 2024). MDCG 2023-4 – Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/vtbl


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