As a SaMD manufacturer, you must ensure that your product meets the relevant regulatory requirements before being placed to the market.
It is critical to work with an EU Notified Body or UK Approved Body that understands the industry and has the experience to review and confirm your product’s readiness for market.
SaMD and “Software in a Medical Device” (SiMD) are not defined in MDR, IVDR. MDCG 2019-11 defines “Medical Device Software” (MDSW) as encompassing all types of software with a medical purpose or acting as an accessory to a medical device, including software embedded within a dedicated hardware medical device.
