The Aftermath of MDR

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The Aftermath of MDR

This is an On-demand recording from November 2021


Regulations struggle to keep up with rapidly evolving AI-driven solutions in the healthcare field. Characteristics and applications of AI are raising ethical and technological challenges that extend beyond current medical software regulatory framework.

Artificial Intelligence: A Regulatory Perspective will address questions such as:

  • What characteristics make AI so challenging?
  • How have commercialized solutions changed to address challenges with AI?
  • What are the implications of the EU MDR?
  • What can we expect from the future?

This live webcast will clarify the terminology and concepts under the umbrella term Artificial Intelligence and how it differs from standard software. Speakers will provide an overview of the regulatory framework on the EU market and analyze current regulatory requirements and limitations under the MDR using real examples of commercialized solutions. Finally, the program will explore the projection of AI and the challenges regulations will face in the near future.


Irene Sanz supports medical device development projects for Novartis. She has been dedicated to the medical devices field for the past five years, working on research and development projects, and as a regulatory consultant for German and Swiss companies. Sanz holds an MSc in biomedical technologies, with a focus on artificial intelligence, from the University Carlos III of Madrid.

Ortzi Olasolo has dedicated most of his career to the design and development of medical devices, a field in which he possesses a strong technical and regulatory background. His current areas of interest are combination products and software as a medical device (SaMD). Olasolo holds an MSc in biomedical technologies from the University of Navarra.