Round Table Session: EU AI Act- Deciphering the act for medical devices and medical writers

Description

The round table discussion will be around the EU AI Act and its implications on medical device manufacturers and technical documentation.

1. AI specifically with respect to medical device and how the EU AI act is impacting it. We will cover risk-based approaches, increased complexity of technical documentation and regulatory submissions with a special mention of intersection with MDR (with focus on integrated documentation, lean writing and compliance and conformity assessments).
2. AI related to functional aspect in medical writing– The discussion will also be around transparency and human oversight requirements when using an AI technology during medical writing. Some other areas that will be covered are: enhanced regulatory literacy required for medical writers (QMS, data governance and risk management) to ensure all communications are compliant and mention the technology’s safety profile. A brief mention of a requirement for medical writers to work with AI technical experts and be literate about the new developments and the integration with the existing working processes will also be discussed.