Preparing for Europe’s New In Vitro Diagnostic Medical Device Regulation

The Essential Guide to EU IVDR Compliance

Technical Documentation

Unlike past IVDD technical file requirements which were general in nature, the new IVDR (Annexes II and III) provides more specific requirements for technical documentation. It also specifies that the technical file “shall be presented in a clear, organized, readily searchable, and unambiguous manner.”

Arena QMS Tip:
Supplier Approval Quality Template

Use the supplier approval template to create a list of your approved suppliers and the parts they provide. This approved supplier list (ASL) is automatically linked to your product record and shows the history of any changes that are made. The ASL can be easily exported and included with your technical file.

Technical documentation should include:

  • Device description and specifications
  • Reference to previous and similar generations of the device
  • Package labeling and instructions for use (in appropriate languages)
  • Product design and manufacturing information (including listing of all supplier and contract manufacturer sites)
  • General safety and performance requirements (Annex I)
  • Benefit-risk analysis and risk management plan
  • Product verification and validation, including:
    – Specimen type/handling
    – Analytical performance
    – Interfering endogenous/exogenous substances investigated
    – Clinical performance
    – Performance of self-testing devices/near-patient testing devices
    – Scientific validity
  • Pre-clinical and clinical data (performance evaluation report)
  • Post-market surveillance plan and reports

Arena QMS Tip:
Technical File Quality Template

Action Item: Ensure that the performance evaluation report and the post-market surveillance plan and report are included in your technical documentationWhen building the technical file for your medical device, use the technical file template to avoid starting from scratch. The template covers all the essential IVDR requirements and can be customized to meet your needs. The technical file is automatically linked to your product record and shows the history of any changes that are made. The technical file can easily be exported for review by your notified body.

Tech Doc Collaboration