The Commission opened a new, yet related, “Have Your Say” initiative: HERE
It reflects the next phase, which is to: Analyse stakeholder feedback (including responses gathered through other channels, e.g., the European Parliament), and outline proposed revisions to better “simplify EU rules for medical devices and in vitro diagnostics” and “ensure availability of safe and innovative devices”. Nothing new is truly known yet. However, the Commission has indicated it intends to share initial proposals by December 2025. Stay tuned; Casus will be monitoring closely.





