Preparing for the EU AI Act
Its Impact on Regulated Laboratories
Executive Summary
The EU Artificial Intelligence (AI) Act, passed in 2024, is the world’s first major regulatory framework governing the development and use of artificial intelligence. For regulated laboratories particularly those operating in pharmaceuticals, diagnostics, chemicals, and medical research the Act introduces a new layer of compliance that must be addressed alongside existing regulations like GxP, ISO 17025, and 21 CFR Part 11.
This whitepaper provides a clear roadmap for understanding and complying with the AI Act, with a focus on how LIMS (Laboratory Information Management Systems), and other digital platforms play a key role in meeting its stringent transparency, risk classification, and documentation requirements.
