The guidance does not intend to address the typical clinical evaluation aspects, for that it refers to MDCG 2020-1, but does emphasize that
For option 1 and 2 MDSW* “the MDSW manufacturer must verify, validate and demonstrate the safety, reproducibility, compatibility and interoperability of the medical device or accessory to a medical device that the MDSW works in combination with, including all various configurations and variants”, but the manufacturer may rely on the compliance of the hardware or hardware component with the MDR, in particular compliance with the GSPRs, when used in line with its intended purpose, under the intended normal conditions of use.
In case of option 3 MDSW the manufacturer becomes responsible for the safety, performance and reproducibility of the hardware or hardware component in its combined use with the MDSW in all intended configurations, and must demonstrate clinical evidence for all intended configurations and the manufacturer of the MDSW has to actively and systematically monitor and assess all information from the market throughout the entire lifetime of the MDSW.
Option 1 MDSW: the hardware or hardware component is placed on the market as an accessory to a MDSW.
Option 2 MDSW: the hardware or hardware component is placed on the market as a medical device either a) as part of a system according to article 22 MDR or b) as a combination with another medical device according to article 2(1), or c) as an integral part of a medical device.
Option 3: the hardware or hardware component is an integral part of a general consumer product or wearable digital product and is not a medical device or an accessory to a medical device and has no intended medical purpose.
https://health.ec.europa.eu/system/files/2023-10/md_mdcg_2023-4_software_en.pdf