The Medical Device Coordination Group released a new guidance document. MDCG 2023-4 on Medical Device Software (MDSW) – Hardware combinations can be found: HERE
The purpose of MDCG 2023-4 is to address the growing number of software devices on the market (an estimated one in four), particularly those that require some hardware (e.g., sensor) to function.
The guidance is to help clarify which specific regulatory considerations apply when:
- The hardware is a medical device (or accessory to a medical device),
- The hardware is not a medical device (or accessory to a medical device),
- The MDSW and hardware share the same legal manufacturer, and
- The legal manufacturers for the hardware and software are different entities.
Not included in the guidance:
- For the purposes of MDCG 2023-4, hardware should not be understood to include desktop PC or cloud computing platform (server).
- Elaboration on aspects related to clinical evaluation or cybersecurity.
The MDCG document provides several practical examples that may be used as a reference point.