AI software that is a medical device and needs a notified body under the EU MDR is a high risk AI system under the EU AI Act. The AI Act adds requirements on risk management, data and data governance, technical documentation, record keeping, transparency towards users, human oversight, accuracy and cybersecurity, robustness, a quality management system and post market monitoring. They are written into the same technical documentation and the same quality system as the MDR file, and the conformity assessment stays with the notified body. The requirements for AI systems under product law such as the EU MDR apply from a later date than those for other high risk systems, and the gap assessment checks the dates that apply to your product.
For a product already CE marked, the work starts with a gap assessment of the existing file against these requirements. Our regulatory specialists then add the missing parts, and our engineers build what the requirements need in the software, such as logging, oversight functions and data lineage.