MDCG Publishes New Guidance on Medical Device Software (MDSW) - Hardware Combinations

The Medical Device Coordination Group (MDCG) has published a new document, MDCG 2023-4, which provides guidance on medical device software (MDSW) - hardware combinations. The document highlights the following key takeaways:

·         Must ensure robust hardware monitoring controls.

·         Mitigate hardware risks to MDSW safety.

·         Clearly document all MDSW-compatible products.

·         Establish a comprehensive risk management plan for MDSW-hardware combinations.

·         Actively monitor market feedback for MDSW-hardware combinations.

·         Comply with MDR safety, reproducibility, and interoperability requirements for MDSW-hardware combinations.

🔗 Original Document:  https://health.ec.europa.eu/system/files/2023-10/md_mdcg_2023-4_software_en.pdf