The EU’s targeted revision of the medical device and in vitro diagnostics framework has entered a more active phase, with nearly 800 amendments tabled in Parliament in July 2026 and the Council’s examination continuing in parallel. The revision would ease certification bottlenecks by removing the five-year cap on certificate validity, scaling notified body involvement to device risk, and letting lower-risk software move down to self-certified Class I. It would also loosen clinical evidence requirements, create fast-track pathways for orphan and breakthrough devices, and regulate AI-enabled devices primarily under the MDR/IVDR rather than the AI Act. This post summarizes the key aspects of the proposed revision, the prospects for their adoption, the issues still in play, and what manufacturers and investors should plan for.