New MDCG 2023-4: MDSW

·         Clarifies regulatory considerations when hardware or hardware components incorporating data collection elements (e.g., cameras, electrical/optical sensors) are medical devices or accessories to medical devices.

·         Outlines scenarios where such hardware or hardware components are not medical devices or accessories to medical devices.

·         Does not elaborate on clinical evaluation or cybersecurity aspects, which are covered in other guidance.

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