In a webinar on software and artificial intelligence (AI/ML) regulation in medical technologies, participants were introduced to the requirements of the MDR, IVDR, and the EU AI Act, which are becoming increasingly detailed for developers of digital health solutions. Special attention was given to the early understanding of qualification, classification, and compliance in preparation for CE marking.
The webinar was led by Stefan Bolleininger, Head of Consultys Medical and Senior Regulatory Affairs Consultant, who specializes in supporting early-stage innovation projects.
The webinar covered the following topics:
- Software Qualification as a Medical Device or IVD under MDR/IVDR
- Classification of Software and IVD Software and its Impact on Regulatory Requirements
- Conformity assessment, including technical documentation, cybersecurity, and clinical/performance evidence
- Standards applicable to software and AI, including IEC 62304, ISO 14971, and IEC 82304-1
- Artificial Intelligence and Machine Learning Systems Requirements: Data Management, Transparency, and Validation
- Interaction between the AI Act and MDR/IVDR and the importance of dual compliance in practice
