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Evaluation ViewAttendees 49

Devices (includes Medical Devices and In Vitro Diagnostics)

Artificial Intelligence – Medical Devices and IVD’s conformity Assessment and CE Marking

Thursday, September 19, 2024
3:15 PM – 4:15 PM PDT
Location/Room: 104 B
Expert Level
The brand new Artificial Intelligence (AI) act introduces new Conformity Assessment and CE marking requirements for medical devices CE marked under the EU MDR or IVDR. Conformity assessment under the AI act, and the role of the AI notified bodies is explained. In addition the interaction with the MDR and IVDR products is explained.

Data is important to develop AI, however the data regulations are challenging. An overview of the most important data related regulations and how to maintain compliancy is discussed. Differences and challenged between the AI act, the GMLP and ISO standards are explained.

Learning Objectives:

  • Upon completion, participants will be able to describe the potential requirements of Artificial Intelligence act conformity assessment for Medical Devices and In Vitro Diagnostic Medical Devices.
  • Upon completion of this session, participants should be able to recognize the main conflicts and overlapping requirements between the AI act and the MDR / IVDR.
  • Upon completion, participants will be able to use approaches for demonstrating compliance and considering risks related to Medical Devices and IVD AI devices.