Impact of the Regulatory Framework on Medical Device Software Manufacturers: Are the Guidance Documents Supporting the Practical Implementation? Comment on "Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We Ready for It? - A Viewpoint Paper".

The increasing use in clinical practice of software such as mobile apps and clinical decision support (CDS) software has only recently been taken up by regulators around the world. Specifically, the European Commission and the US Food and Drug Administration (FDA) have updated their regulatory framework in the last years. Van Laere et al have given an extensive overview of the European and US approaches to regulate CDS software. This commentary further discusses regulatory differences between the two geographies and their impact on manufacturers of medical device software. We discuss the practical implementation of the regulatory framework for medical device software (especially CDS software) with a reference to the available international guidance documents and their limitations. Given the direction of stricter regulatory oversight in Europe, additional European guidelines/examples are desirable to enable a pragmatic regulatory approach ensuring continued access to innovative medical device software for European patients.

Regulatory Aspects of the Use of Artificial Intelligence Medical Software.

The rapidly evolving scenario of Artificial intelligence (AI) in medicine comes with new regulatory challenges, including certification, ownership, and control of data sharing, privacy protection, and accountability. The Medical Physicists (MPs) are traditionally responsible for ensuring the safety and quality of technology implementation in diagnostic and therapeutic settings. As such, they are also expected to contribute to the introduction of AI medical devices in routine clinical practice. Specifically, the MPs will play a stakeholder role for AI tools procurement, acceptance testing, commissioning, and quality assurance to confirm the claimed performances in relation to the medical device's intended use. Moreover, MPs who act as co-creators of such AI tools, will play a pivotal role in product requirements definition, data collection and annotation, clinical evaluation, support for regulatory pathways and marketing through scientific congresses and scientific publications. As AI software differs from the traditional (hardware) medical device that the MP is used to introduce in clinical settings, there is a need to acquire new competencies in the field of AI and its regulatory aspects. The purpose of this paper is to provide MPs with practical guidelines on regulatory aspects of AI medical devices, in the European and in the US landscape.