Artificial intelligence (AI) and blockchain-enabled solutions are transforming healthcare delivery, catalyzing the shift from reactive treatment models to proactive, precision-based care. By enhancing accessibility, personalizing clinical decision-making, improving efficiency, reducing errors, and offloading administrative burdens, these technologies are driving a smarter, more patient-centered healthcare ecosystem.

Dr. Al-Siddiq will explore real-world applications of AI, including how predictive analytics is advancing clinical decision making and how adaptive diagnostics are enabling personalized patient care. He will also examine how blockchain strengthens data security, promotes transparency, and drives seamless interoperability across healthcare systems.

While these technologies promise significant advances in patient outcomes and operational efficiency, they also introduce complex challenges. This presentation will provide an overview of current regulatory approaches from agencies such as the FDA, highlighting emerging frameworks aimed at balancing innovation with patient safety. Critical issues, including AI algorithm transparency, machine learning validation, cybersecurity risks, and the governance of decentralized data must be addressed to ensure safe and effective integration.

Attendees will gain actionable insights into navigating regulatory gaps, managing compliance risks, and fostering collaboration across industry and regulatory bodies. Strategic approaches for responsible digital transformation will be discussed, offering a roadmap to harness the full potential of AI and blockchain in the evolving healthcare landscape.

A structured and sustainable interaction with a Notified Body can be a crucial aspect for manufacturers to navigate the complexities of EU MDR and IVDR conformity assessments, potentially influencing the process outcome in a significant manner. The regulatory basis of effective communication between manufacturers and Notified Body can be found within the MDR itself, MDCG 2022-14 and Team NB Code of Conduct document. Indeed, while independence and impartiality requirements remain pillars within the regulation, they do not preclude exchanges of technical information and regulatory guidance between those parties as far as such dialogues do not constitute as a consultancy service. The increased clarity in that regard is expected to have overcome the reluctancy of some Notified Bodies to engage in that process. The aim is therefore to go through best practices in effective communication with Notified Bodies for each phase of an EU MRD and IVDR conformity assessment process such as the application review, the QMS audit, and the technical documentation review, to avoid common pitfalls and promote an efficient and effective path for manufacturers.

One of the core objectives of MDR 2017/745 and IVDR 2017/746 is to establish a robust, transparent, predictable, and sustainable regulatory framework for medical and in vitro diagnostic medical devices which ensures a high level of safety and health whilst support innovation. However, manufacturers are calling for reforms possibly addressing the key areas of efficiency, governance, and innovation, proposing in this case principles to swiftly connect the latest medical technologies to European patient and health systems, for instance through dedicated assessment pathways and early dialogues with developers. While those calls for reform may look at future regulatory scenarios embracing early pre-filings, dedicated and accelerated pathways, pre-certification access models or consideration of regulatory decisions taken by other jurisdictions, it remains of paramount importance to apply the current regulatory framework in a way which could more closely match the innovation dynamics of medical and IVD devices. The aim is to gather lesson learnt from the Notified Body experience and identify possible means to mitigate the complexity of bringing innovative products to the market.