Your MDR file is no longer the whole file. If your device contains AI and needs a notified body, it is a high-risk AI system under the AI Act, assessed by the same notified body. From 9 December 2026, the revised Product Liability Directive treats software as a product, and missing evidence can be presumed against you.

This free 8-page briefing for regulatory and quality leads selling into the EU from outside it covers:

🔵 Which regimes reach your device, and when each one applies

🔵 Why your MDR authorised representative doesn't cover the AI Act

🔵 What your notified body will ask that your MDR file can't yet answer

Written by Yuliia Habriiel, LLB, AIGP, author of a 22-chapter EU AI Act field manual.