REGULATION & VALIDATION OF LATERAL FLOW ASSAYS

From Intended Purpose to Real-World Performance

What does successful validation of a lateral flow assay really require under the EU IVDR?

This presentation explores validation from a practical, lifecycle perspective beginning with the intended purpose and early product development and continuing through performance evaluation, usability, manufacturing, design changes and post-market surveillance.

It explains why analytical performance alone may not be enough, how the intended purpose and associated risks shape the validation strategy, and why real-world factors such as user handling, sample variability, environmental conditions and material variability need to be considered.

The presentation also clarifies the distinction between performance evaluation and practical validation and shows how validation should remain connected to risk management and usability throughout the product lifecycle.

KEY TOPICS

• IVDR considerations for lateral flow assay development
• Why LFAs are particularly validation-sensitive
• Intended purpose as the foundation of the validation strategy
• Risk-based validation and its connection to ISO 14971
• Scientific validity, analytical performance and clinical performance
• Performance evaluation versus practical, real-world validation
• User dependency and usability considerations
• Validation for professional users versus lay users
• Validation from prototype through CE marking
• Manufacturing transfer, process variability and lot-to-lot considerations
• Managing design changes and determining revalidation needs
• Post-market surveillance and PMPF as part of the validation lifecycle