Software As a Medical Device (SAMD) in EU MDR and its submission process.

European Medical Device Regulation (EU MDR) will create a robust, transparent, and sustainable regulatory framework, recognized internationally, This would improve clinical safety and create fair market access for manufacturers, it includes defining aspects, qualification criteria, classification, clinical evaluation, CE certification and QMS.

For continued innovation, the SaMD manufacturers should understand the proposed regulations and adopt a robust system supporting all the devices and software functionalities with the EU MDR Regulatory recommendations. This is to ensure high quality and compliance.