The evolving regulatory landscape for Drug-Device Combination (DDC) products requires manufacturers to meet stringent safety reporting obligations under FDA (MedWatch, 21 CFR Part 4) in the USA and EU Medical Device Regulation (MDR; Regulation 2017/745, Article 117, and Notified Body Opinion [NBOp] requirements). Ensuring compliance while managing increasing data volumes and regulatory scrutiny demands innovative solutions—Automation and Generative AI (GenAI) offer a transformative approach.
This presentation will explore how AI-driven automation enhances adverse event detection, leveraging Natural Language Processing to extract safety signals from clinical trials, electronic health records, and real-world data sources. Predictive analytics enables proactive identification of trends in device malfunctions and drug interactions, reducing regulatory risks.
A key focus will be on Article 117, which mandates an NBOp for integral DDCs before EU market approval, significantly impacting compliance timelines. We will discuss how AI-powered automation streamlines Notified Body submissions, ensuring seamless integration with EUDAMED and accelerating incident reporting. Additionally, AI-driven chatbots can assist healthcare professionals in real-time reporting, improving data accuracy and integrity.
Attendees will gain actionable insights into AI/machine-learning-driven pharmacovigilance, learning how automation can reduce costs, optimise compliance workflows, and enhance patient safety, making it an essential tool for future-proofing DDC regulatory strategies.
SAFETY REPORTING PERSPECTIVE: Transforming DDC Safety Reporting with Automation and Generative AI
Ajit Sankar, Accenture, Switzerland
Dr. Ajit Sankar Mallik leads the EU MedTech Clinical Practice at Accenture. With 15+ years of global clinical, regulatory, and quality affairs experience, he specialises in Medical Devices, Drug-Device Combinations (DDC), and In Vitro Diagnostics (IVDs), with a strong focus on Software as a Medical Device (SaMD) and Digital Health products.
His expertise spans clinical evidence generation, regulatory strategy development, and product lifecycle management, ensuring compliance with FDA, EMA, Health Canada, Swissmedic, and EU Notified Bodies. He has played a key role in achieving Notified Body Opinions (NBOp) under Article 117 of MDR for various DDCs, including insulin and GLP-1 therapies.
Dr. Mallik holds an MDPhD from the University of Zurich, a Master’s degree in Medical Science & Technology from IIT Kharagpur, and was a visiting scientist at Harvard Medical School. His regulatory leadership has contributed to breakthrough device designations, per-market approvals, and Medical Device Regulation (MDR) compliance across global markets. His work integrates AI-driven automation and regulatory intelligence, optimising safety reporting and market entry strategies for DDC products.