Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

An Overview of Current Regulatory Environment Regarding Artificial Intelligent (AI)-Based Medical Device Software (MDSW) in EU

Deanna Yuching Balakhonova (Abschlußjahr: 2023)

Summary
Language: English
This thesis aims to illustrate the current regulatory framework for AI-based MDSW in EU. It first addresses the regulatory framework of medical device software (MDSW) from MDR/IVDR together with the complementing MDCG Guidances then the EU regulatory framework of AI from draft AI Act in order to achieve a thorough comprehension about the EU regulatory framework of AI-based MDSW (AI MDSW). The work starts with the background, scope, and definition in the legislations. In cases where no exact definition is included, definition from previous publication or proposed definition from groups under EC were taken. The basic knowledge of AI and AI-relevant techniques is introduced, especially the common ones listed in the draft AI Act. AI is shown to push the technology to an unprecedented peak of achievement, as it minimizes human error with the incorporation of big data and machine learning techniques, compared to the systems without such components. The nowadays software is significantly more capable compared to the past times, and this is also true for the software related to the medical systems. Some applications in medical device fields were listed as examples and the approval history between 2015 and first quarter of 2020 was reviewed with aim to learn the trend.
To illustrate the practicality of regulating AI MDSW under both legislations, the thesis clarifies the relationship between how MDSW and AI systems are regulated under the two regulatory frameworks, and further carries out some comparison among the articles to review the discrepancies or confusing parts regarding definitions, responsibilities of different stakeholders, and procedures. As the draft AI Act currently receives numerous proposals of amendment, recommendations and opinions from different stakeholders are also included in the thesis. Considering that implementing the draft AI Act for AI MDSW would be a challenge before further clarification or proper amendments are made, this thesis discusses about potential issues, meanwhile trying to find corresponding solutions or alternatives. In the end, international standards are included, which despite being outside of the scope of this work, provide more insight into the selected topic.
Pages: 59
Annexes: 4, Pages: 2