IVDR Alert: Don't Let These 3 Technical File Pitfalls Halt Your Certification

The EU IVDR (In Vitro Diagnostic Regulation) transition continues to be a massive resource drain, especially for SMEs. We often see manufacturers focus heavily on the QMS, only to hit a wall during the Notified Body review of their Technical Documentation.

Here are the three most common, yet avoidable, IVDR technical file mistakes we see that lead to immediate Notified Body rejection or long delays:

Static Risk Management (ISO 14971): Risk Management under IVDR must be a living process tied directly to the lifecycle. Treating your risk file as a one-off document—not integrating it with Post-Market Surveillance (PMS) data—is an immediate red flag.

Incomplete Performance Evaluation: The IVDR demands robust evidence across three pillars: Scientific Validity, Analytical Performance, and Clinical Performance. Relying on legacy data or an incomplete gap analysis in any of these areas will kill your submission.

Missing Traceability: The Notified Body must see a clear, auditable link from your device's Intended Use, through your General Safety and Performance Requirements (GSPRs), down to the verification/validation reports. Poor traceability = incomplete evidence.

The Fix: Don't wait for your Notified Body audit to find these holes. A targeted IVDR Technical File Gap Analysis now is the fastest route to compliance. We specialize in structuring Annex II and III documentation to be audit-ready.

IVD Manufacturers: Which of these three areas is currently causing your team the most anxiety? Share your thoughts below.

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