The Commission’s proposal COM (2025) 1023 final (widely known as MDR 2.0) aims to simplify and streamline the MDR by removing duplicative procedures and adopting a more risk-based approach.

Published on 16 December 2025 and now before Parliament and the Council under the ordinary legislative procedure, it responds to nearly a decade of practical experience with the original regulations.

Beyond simplification, one objective of MDR 2.0 involves seeking a single conformity assessment process that properly integrates AI and cybersecurity requirements rather than preserving overlapping regimes.

In our whitepaper below, our Head of Regulatory Richie Christian recaps the interconnection between the MDR and EU AI Act, discusses the potential impact of the proposed changes in MDR 2.0 related to AI in MedTech, and offers practical preparation advice for manufacturers of AI-enabled medical devices. View in the screen reader below, or download at the button.

And should you have an AI in MedTech challenge, get in touch to find out how our expert team could help.