Last month (July 2026), CEN & CENELEC published the European Standard EN 18286, which defines a QMS specifically to meet Article 17 of the EU AI Act.

In our 5-minute guide below, our Head of Regulatory Richie Christian recaps the context behind this standard, expands on what EN 18286 requires, and outlines the potential impact for manufacturers of AI-enabled medical devices.

You can read the guide in the viewer or download at the button – and should you have a regulatory challenge related to your medical device, get in touch with our experts.