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Q&A | Impact of the EU AI Act on Medical Device and IVD Manufacturers

Coenraad Davidsdochter, MSc Coenraad is a professional with over 20 years’ experience in software development for the medical sector. He has worked on many aspects as requirements manager, functional designer, test engineer, implementation consultant and product owner, but in the last 10 years mostly on regulatory affairs, quality assurance, information security, GDPR and privacy at ICT Healthcare Technology Solutions (formerly BMA). 

The EU AI Act is a proposed regulation by the European Commission aimed at ensuring that AI systems used within the European Union are safe, transparent, and uphold fundamental rights. It classifies AI systems into different risk categories and imposes varying levels of regulatory requirements based on the potential impact of these systems.

AI is becoming an integral part of our daily lives, and its governance affects everyone from tech giants to individual users. The EU AI Act is set to become a benchmark for AI regulation globally, influencing policies in other regions as well. Staying informed about these regulations can help you navigate the changing landscape of AI technology responsibly and effectively.

Watch the Q&A with Software and AI Expert Coenraad Davidsdochter, diving into several top-asked questions about the EU AI Act.


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