Find here all our blog posts tagged with: IVDR.

Abstract image of two intersecting light arcs, one medical and one technological in form, with a visible unaligned gap between them.

The Change-Control Gap Between MDR and the AI Act

Predetermined change control plans reveal the specific reconciliation gap between MDR/IVDR certification and EU AI Act obligations for adaptive medical algorithms.

Abstract image of a tissue sample overlaid with a data grid, symbolizing an AI algorithm functioning as a biological biomarker

When the Algorithm Is the Biomarker

Computational pathology AI blurs device and biomarker regulation, but predetermined change control plans, not model freezing, may be the real fix.

Two diverging highway lanes at dusk, one illuminated and one dim, leading toward an empty horizon.

Two New Fast Lanes for AI Devices, No New Evidence Standard

EU and FDA are both building faster pathways for AI medical devices, but neither has defined what evidence should earn a device the fast lane.

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.

Two overlapping translucent regulatory frameworks depicted as intersecting glass panels above a European skyline.

Europe's AI Act and MDR Collide, and MedTech Wants a Rewrite

European MedTech is lobbying to revise how the EU AI Act and MDR/IVDR interact, and regulated buyers should build to the stricter combination now, not wait for the fix.

Two shifting translucent glass panels overlapping in a clinical white laboratory space, symbolizing two regulatory frameworks being revised in parallel.

Europe's AI Act and MDR Are Being Rewritten at the Same Time

European regulators are revising the AI Act and MDR simultaneously, leaving life sciences compliance teams no stable baseline to build against.

A multi-layered glass hourglass with sand suspended between tinted panes, symbolizing a regulatory grace period built from stacked compliance layers.

The Extended Clock Is Not a Reprieve

The EU AI Act's delayed enforcement dates for medical device AI give sponsors more runway, but only if they use it to align MDR/IVDR and AI Act evidence now.

Two parallel corridors of differing length in a clinical facility, symbolizing divergent regulatory paths for medical device approval.

Europe's New Fast Lane for Breakthrough AI Devices Comes With No Governance Shortcut

The EU's new Breakthrough Devices framework under MDR/IVDR speeds review timelines but leaves AI governance obligations fully intact.

Hands fitting together translucent glass gears on a dark table, symbolizing the mechanics of valuing regulatory governance in a life sciences acquisition.

In HealthTech M&A, AI Governance Is Now a Line Item on the Term Sheet

Buyers in HealthTech and MedTech deals are pricing AI governance maturity directly into valuation, not treating it as a closing condition.

Abstract layered forms contrasting a fixed structure with a fluid, shifting one to evoke static documentation versus adaptive systems.

MedTech Diligence Now Has to Read Change Plans, Not Just Technical Files

AI-enabled devices are adding predetermined change control plans to MDR/IVDR technical files, and buyers evaluating MedTech targets need to diligence both.