AI as a medical device

Course description

The course, delivered in English, provides an up-to-date overview of the innovations and challenges that emerging technologies such as AI pose for the design, production, and market placement of medical devices. The course is aimed primarily, though not exclusively, at business professionals (from start-ups to multinational companies) involved in regulatory and compliance aspects of medical devices. The core of the course is the analysis of the European Medical Device Regulation (MDR) and the Artificial Intelligence Act (AI Act). In particular, these topics will be addressed with a focus on risk analysis from a multidisciplinary perspective. More specifically, a regulatory and legal viewpoint will be combined with technical and clinical perspectives. The course will enable participants to acquire analytical tools and criteria oriented toward problem-solving of critical issues that arise in daily practice.

Course target

The adoption of the Medical Device Regulation (MDR), despite the provision of transitional periods for its gradual implementation, has led to an increase in compliance obligations for manufacturers, both in terms of quantity and complexity. The uncertainties arising from the need to adapt to the new regulatory framework are further compounded by the adoption of the AI Act, which introduces a comprehensive regulatory framework for AI systems, with particular attention to high-risk systems. This framework also applies to AI systems that are components of medical devices or medical devices themselves. For such devices, both the MDR and the AI Act apply simultaneously, allowing manufacturers to integrate AI Act requirements into the processes and documentation required by the MDR. On the one hand, this possibility of integration helps avoid duplication and makes compliance more efficient. On the other hand, it is still unclear how such integration can be practically implemented. Therefore, professionals need specific training on these topics in order to effectively meet the compliance requirements set by sector regulations and beyond. In particular, it is necessary to provide a method that enables professionals to navigate the legal and operational uncertainties arising from the interaction between the MDR and the AI Act. Moreover, solving these compliance challenges requires consideration not only of the evolving regulatory framework but also of the economic and clinical realities, so that professionals can address compliance issues efficiently and realistically, in line with the actual needs of the company or organization they work for.

Training objectives

The course is primarily designed to train compliance managers in the medical device sector, but also consultants, corporate lawyers, attorneys specializing in healthcare law, researchers, AI developers for medical and e-health applications, healthcare professionals, and private companies of all sizes (start-ups, spin-offs, SMEs, multinationals) on the following areas. 

Teaching methods

The methods to achieve the above-mentioned results will include lectures and practical workshops.

Course programme

The Course programme, lasting three days, is structured as follows:

• Module I – AI and medical devices:  Medical Practice and Regulatory Challenges 

• Module II – AI and medical devices: Technical perspectives 

• Module III – AI and medical devices: Product Liability 

Attendance certificate

At the end of the Course, those who have attended at least 80 % of the lessons, successfully passed the required tests and are up to date with their enrolment fee payments will receive a certificate of attendance from the Sant'Anna School of Advanced Studies, valid within the limits permitted by law.