EU IVDR (In Vitro Diagnostic Regulation)

EU IVDR (Regulation (EU) 2017/746) reshaped how in vitro diagnostics reach and stay on the European market. Rule-based classification, performance evaluation, scientific validity, analytical and clinical performance evidence, and stronger post-market requirements affect most IVD portfolios. Companion diagnostics and higher-risk class devices face especially heavy Notified Body involvement and longer review cycles than many teams budgeted under the prior IVD Directive.

Viltis supports IVD manufacturers with IVDR gap analysis, performance evaluation planning, technical documentation upgrades, and remediation sequencing. We help interpret how classification changes affect your catalog and what evidence is still missing for scientific validity and clinical performance. Viltis is not a Notified Body and does not certify CE marking; we prepare documentation and processes for the assessments those bodies conduct, including responses to questions during review.

Parallel FDA IVD strategies often run beside IVDR work. Evidence packages, intended purpose statements, and post-market vigilance systems should be planned together where possible so studies and claims do not conflict across regions. We help you prioritize legacy products when Notified Body capacity forces hard choices about which SKUs stay on the market first and which need interim commercial decisions.

IVDR documentation fails when performance claims, IFU language, and analytical evidence are written by different owners without a single intended purpose statement. We push for that alignment early in remediation so Notified Body review does not stall on inconsistencies that could have been fixed before submission. For companion diagnostics and software-assisted IVDs, we help coordinate intended purpose, algorithm change control, and performance claims so updates do not silently invalidate the evidence package that supported conformity assessment.

EU IVDR support commonly includes

• Classification and conformity assessment route planning
• Performance evaluation plans and reports (PEP/PER) support
• Technical documentation remediation for IVDR Annexes
• PMS, PMPF, and vigilance process design
• Legacy product prioritization against Notified Body capacity
• Alignment with FDA diagnostic submission evidence where relevant
• Cross-functional workshops with RA, clinical, and quality owners

IVDR readiness is ongoing performance oversight, not a single dossier push. Viltis helps diagnostic teams close documentation gaps and keep post-market systems equal to the regulation’s day-to-day expectations. Treat IVDR as continuous performance discipline and Notified Body review becomes manageable rather than existential.