IVDR 2027: The Clock is Ticking
We track 3,334+ IVDR certificates across 20+ notified bodies in real time. Don't miss your deadline.
What is IVDR?
The In Vitro Diagnostic Regulation (EU) 2017/746 replaces the outdated IVDD and introduces a fundamentally stricter regulatory framework for IVD devices sold in the European Union. All IVD manufacturers must transition their certificates before the deadline — or lose market access.
The transition affects thousands of devices across risk classes, from low-risk self-tests to high-risk companion diagnostics. Notified bodies are overwhelmed with applications, creating a bottleneck that could leave unprepared manufacturers without valid CE marks.
Key Deadlines
Critical transition milestones for IVDR compliance
Transition Date for Class D Devices
High-risk IVDs (class D) under legacy IVDD must have valid IVDR certificates by this date. This includes companion diagnostics and certain infectious disease tests.
Full IVDR Transition Deadline
All remaining IVDs (class A–C) must transition to IVDR certificates. Devices without valid IVDR certification cannot be placed on the EU market.
Legacy Device Sell-Through Ends
Devices placed on the market before the transition deadlines can no longer be sold. Full IVDR compliance is mandatory for all IVDs on the EU market.
How We Help You Prepare
Signal intelligence tools for IVDR transition management
Certificate Tracking
Real-time monitoring of 3,334+ IVDR certificates across 20+ notified bodies. See which NBs are issuing, which are backlogged, and which certificates are approaching expiry.
Gap Analysis
Identify which of your devices still need IVDR transition. Map your current IVDD certificates to their IVDR equivalents and prioritize by risk class and deadline proximity.
Notified Body Monitoring
Track notified body capacity, designation status, and performance metrics. Identify which NBs have capacity for your device class and which are experiencing bottlenecks.
Compliance Alerts
Automated notifications for certificate expirations, regulatory updates, and deadline reminders. Never miss a critical IVDR compliance milestone.
Prepare for IVDR 2027
Don't wait until the deadline. Start monitoring your IVDR transition landscape today with regulatory signal intelligence.