Share page on LinkedIn

IVDR technical file remediation

Understanding technical file requirements for a successful transition

The new In Vitro Diagnostics Regulation (IVDR) requirements impact the entire IVD lifecycle. As a result, manufacturers may be experiencing significant increases in workloads across the medical device and diagnostic value chain. Many factors are contributing to this workload including proper technical documentation, conformity assessments, quality management requirements and post-market surveillance, as well as maintaining evolving relationships with and responsibilities to notified bodies (NBs).

Discover the key elements of a successful IVDR techical file remediation strategy, including:

  • Assess your notified body needs

  • Conduct a classification assessment

  • Determine gaps for IVDR compliance

  • Review technical file component checklist for successful remediation

  • Discover a technical file assembly and delivery case study

IVDR technical file remediation factsheet

Planning and implementing a successful IVDR technical file remediation strategy