Find here all our blog posts tagged with: Medical Devices.

An hourglass with mechanical device fragments suspended in falling sand, symbolizing a regulatory deadline that has shifted but not disappeared.

The EU AI Act Extension Is Not the Relief It Looks Like

Brussels pushed back the high-risk AI Act deadline for regulated medical devices, but MDR and IVDR certification bottlenecks did not move with it.

An hourglass on a steel table in a dim clinical corridor, sand falling, symbolizing a regulatory countdown for medical device AI.

The EU AI Act Grace Period Is a Countdown, Not a Pause

Brussels pushed high-risk AI enforcement for medical devices to 2027 and 2028, but the multi-year MDR/IVDR build-out clock is already running.

A glass boundary dividing a clinical space into two zones of light, symbolizing a shifting regulatory classification line.

The Qualification Test That Redraws the AI Device Line

A new EU Court judgment on medical device qualification means AI tools built as informational or decision-support software may already sit inside MDR and IVDR scope.

A glass-like translucent heart floating above a faint grid of pulse waveforms, symbolizing AI-assisted diagnostics under regulatory review.

FDA's GenAI Guidance Gap Puts Lifecycle Design on the Critical Path

FDA is still soliciting input on generative AI device oversight while conventional AI/ML tools keep clearing through 510(k), forcing sponsors to design lifecycle monitoring ahead of guidance.

Abstract photograph of light flowing between a human hand and a robotic diagnostic arm, symbolizing continuous oversight of AI in medicine.

FDA's Discussion Paper Moves the Goalposts on GenAI Devices

FDA's generative AI discussion paper signals a shift from one-time approval to continuous, competency-based testing that life sciences compliance teams should prepare for now.