The news feels bittersweet. With 10+ of experience in healthcare AI, I have seen enough shitty products to genuinely welcome strict regulation for critical sectors; however, this shift threatens to dilute the sense of urgency that was growing in the sector.

We recently built a platform specifically to navigate the complex intersection of MDR (Medical Device Regulation) and the AI Act, relying on the pressure of hard deadlines. By introducing flexible timelines linked to technical standards, the EU risks signaling that compliance is a secondary concern, potentially stalling the momentum... and at this point patient safety is my biggest concern, not our platform

This introduces chaos rather than relief. Companies do not need lower standards; they need clarity.

We can compete effectively against high standards as long as the rules are clear. EU AI Act was clear. This proposal substitutes the certainty of a high bar with the confusion of a sliding scale, which may hinder the industry more than it helps :/