Description: As the EU Artificial Intelligence Act (AIA) is expected to enter into force in 2024 and applicable in 2027 for Medical Devices, planning for its implementation should start now. The horizontal nature of the AIA means that it will interplay with the Medical Devices Regulation (MDR), where tensions and inconsistencies are likely to emerge. In particular, the AIA requires a single conformity assessment procedure for AI-enabled medical devices covered under the MDR. Therefore, for developers of AI-enabled medical devices, the AI Act poses several challenges, including additional obligations related to testing, risk management, post-market monitoring, and documentation. During this session, we will identify gaps regarding specific requirements of AI conformity assessment and discuss the significant impact on the medical devices industry as well as ongoing debates.
Moreover, during the session we will delve further into the issue of AI-enabled medical devices’ model changes that may be considered as substantive modification and, therefore, trigger a new conformity assessment or require a new regulatory clearance/approval. Such regulatory expectations may not coincide with the rapid pace of medical device innovation and enable more personalized healthcare. For this reason, a predetermined change control plan (PCCP) may be the way of managing certain device changes, avoiding the need for such post-market assessments – and the delay and expense entailed when it is determined that a new submission is needed – through prospectively defining a process for making post-market changes.
This session will give participants the opportunity to explore a pilot /sample PCCP template with specific examples. After attending this session, participants will gain more confidence in the additional requirements set by the AIA on AI enabled medical devices and how to use PCCP to plan modifications to a device, while continuing to provide a reasonable assurance that the device is safe and effective.
Learning Objectives:
Have a better understanding of how the AI Act interlinks with the existing medical device regulation
Have a better understanding of how the MDR conformity assessment process will be different, due to the application of the AI Act for AI-enabled Medical Devices
Define device specific PCCP templates for pre-approvals
Describe anticipated changes in AI/ML device much better and demonstrate and adequately address the required controls
Conduct a much better structured and framed PCCP submission
Describe how PCCP submissions are required to be structured under current guidance documents
