Software and artificial intelligence are increasingly central to modern healthcare technologies. At the same time, the Medical Device Regulation, In Vitro Diagnostic Regulation, and the EU Artificial Intelligence Act introduce specific regulatory requirements for the development, validation, and commercialization of these solutions.
Understanding these requirements early is essential for successful development and market access.
Topics covered
- How to determine whether software qualifies as a medical device or in vitro diagnostic under the Medical Device Regulation and In Vitro Diagnostic Regulation
- Classification of software and in vitro diagnostics software and its impact on regulatory obligations
- Conformity assessment requirements, including technical documentation, cybersecurity, and clinical or performance evidence
- Applicable standards for software and AI, including IEC 62304, ISO 14971, and IEC 82304-1
- Regulatory requirements for artificial intelligence and machine learning systems, including data governance, transparency, and validation
- Interaction between the EU AI Act and the Medical Device and In Vitro Diagnostic Regulations, and the practical implications of dual compliance
The webinar will be led by Stefan Bolleininger, Managing Director and Senior Regulatory Consultant at Consultys Medical, specializing in regulatory strategy for digital health, medical software, and AI-based technologies.
The webinar will be recorded.
The project Biomedical and Photonics Research Platform for the Development of Innovative Products – BioPhoT is implemented within the framework of the national research programme 'Innovation Fund – Long-Term Research Programme', funded by the Ministry of Economics. Project number: IVPP-EM-Innovation-2024/1-0002.
