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IVD Technical Documentation Compilation

What documentation is required for successful market entry under Regulation (EU) 2017/746?

The exact documentation required will change on a case to case basis, and the detail expected will depend largely on the risk classification of the device. The following documentation is generally required by default:

  • Device Description and Specification
  • Classification Rationale
  • Applicable Standards List
  • Information Supplied by the Manufacturer: Includes IFUs and Labelling
  • Design and Manufacturing Information
  • General Safety and Performance Requirements Checklist
  • Risk Management
  • Product Verification and Validation
    • Performance Evaluation Report
    • Stability
    • Software V&V

The most resource intensive section will be the Product Verification and Validation which is the main body of evidence of scientific validity, analytical and clinical performance. A robust Performance Evaluation Plan is key in ensuring all regulatory requirements are met, and that all claims are scientifically substantiated.

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