Stability (Reagents) (IVDR)

BPG reference: Team-NB BPG-IVDR V2 (V&V — Stability, approx. pp. 19–21)
Covers: shelf-life, open-vial/on-board stability, transport simulation, in-use stability

Checklist

• [ ] Stability studies support claimed shelf-life (real-time and/or justified accelerated data)
• [ ] Open-vial / on-board stability protocols and reports where claimed
• [ ] Transport stability / challenge conditions aligned with labelled storage
• [ ] Calibrators, controls and reagents addressed separately where applicable
• [ ] Predefined acceptance criteria; transparent statistics
• [ ] Conclusions reflected in IFU storage/use statements and risk management
• [ ] Multiple configurations/pack sizes: representative or worst-case coverage with extrapolation rationale

Common NB gaps

• Accelerated data only without real-time plan/justification
• Missing open-vial data despite multi-day IFU claims
• Transport conditions contradict labelled storage