Product dossier: prequalification of in vitro diagnostics programme

17 items · Health · Medium difficulty · 30 min

Plain-language checklist to prepare an IVD product dossier for prequalification.

• Review prequalification eligibility and scope

  Confirm the programme accepts your device type and intended use.

• Confirm device classification and intended use

  State clinical purpose, specimen type, and target population.

• Collect existing regulatory approvals and certificates

  Include national approvals, CE marks, or equivalent evidence.

• Assemble the device technical file

  Gather device description, drawings, and design rationale.

• Describe manufacturing process and quality controls

  Summarize production steps, controls, and in-process checks.

• List raw materials, suppliers, and critical components

  Name key suppliers and specifications for critical inputs.

• Compile analytical and clinical performance data

  Include sensitivity/specificity, study summaries, and methods.

• Summarize stability, storage and shelf-life testing

  Provide conditions, expiry, and supporting test results.

• Prepare labeling and instructions for use (IFU)

  Include user-friendly IFU, intended audience, and local languages.

• Document the quality management system

  Provide ISO certificates or written QMS procedures.

• Include manufacturing batch records and lot-release criteria

  Attach example batch records and release test results.

• Prepare risk management and safety documentation

  Add risk analysis, mitigation, and residual risk statements.

• Compile a post-market surveillance and vigilance plan

  Outline how you will monitor and report performance after launch.

• Create a clear dossier index and document map

  List files, sections, and page references for reviewer ease.

• Perform an internal completeness and quality check

  Verify all signatures, dates, and required attachments are present.

• Submit the dossier to the prequalification programme

  Follow the programme’s submission portal and file format rules.

• Confirm receipt and track the review timeline

  Record reference numbers and expected response dates.

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