IVDR Compliance for Custom LDT Assays

A practical walkthrough of the Article 5.5 pathway for laboratory-developed tests, from regulatory strategy to validated assay

If your clinical trial includes EU sites or uses a diagnostic not covered by a CE-marked device, IVDR applies to you.

The regulation reaches further than most teams expect, and the consequences of approaching it late are costly: repeated experiments, delayed timelines, and gaps in your technical dossier that can derail your clinical program.

In this presentation, Cerba Research’s laboratory, regulatory, and scientific directors walk through the full Article 5.5 process using a real case study. The focus is practical:

• What you need to do at each phase
• Where things go wrong
• Why starting early determines whether you validate successfully or go back to the beginning

What you will take away

1. IVDR compliance under Article 5.5 might be an EU regulation, but it has global implications. Any program running trials at EU sites or relying on a diagnostic without CE marking falls under this regulation regardless of where the sponsor is based
2. Regulatory strategy, scientific teams, QA, project management and the clinical sponsor all need to be aligned before method development begins, because bringing any of the in later created rework, not iteration.
3. Design controls sets the acceptance criteria your assay must meet before any experiments run, because every development needs to connect back to patient need and stand up to regulatory scrutiny
4. The patient inclusion and exclusion threshold is the single point in your assay where precision is non-negotiable. It needs to be established early, grounded in prior clinical data, and your validation must be built around it.

Watch the recording: