Regulated Software Research Centre >> AI in Medical Device Development

AI in Medical Device Development

Artifical Intellenge (AI) is being incorporated into all parts of our daily lives, including healthcare and medical devices. But the incorporation of such technology into critical safety areas, such as medical devices, requires safe, reliable regulations. 

The Artificial Intelligence Act proposal (AIA) by the European Commission (EC) is considered the first legal attempt to harmonise rules for AI systems. The proposal is designed as a general approach to regulateing AI systems in different domains, including Medical Devices (MD). Devices for medical purposes are regulated under the Medical Device Regulation (MDR) to ensure the safety of concerned patients and to enhance the quality of MDs in the European Union without ignoring inhibiting innovative and creative technologies.

Much critical work is currently being undertaken with the RSRC to amend and review existing regulations and, where necessary, develop new standards to ensure the safe, reliable, trustworthy and secure adoption of AI techniques into MD software development.