MDCG 2023-4 Guidance for Medical Device Software (MDSW) – Hardware combinations published
19 October 2023
The guide “MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations, Guidance on MDSW intended to work in combination with hardware or hardware components”, endorsed and established by the Medical Device Coordination Group (MDCG), was published on 18 October 2023.
The guidance examines and provides clarifications on which specific regulatory considerations apply when the hardware or hardware component incorporating a data collection element (camera, electrical/optical sensors etc.) are a medical device or an accessory to a medical device. It also outlines scenarios where the hardware or hardware component incorporating a data collection element are not medical devices or accessories to a medical device.
The new guidance does not enlarge on aspects related to the clinical evaluation or cybersecurity for the products in focus since these topics are covered in other guidance documents, MDCG 2020-1 and MDCG 2019-16.