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Where real-world testing was conducted under Article 60, the registration and associated documentation are retained: the Annex IX submission, the real-world testing plan, informed consent records, testing results, and any suspension or termination records. The final test report is incorporated into the AISDP evidence pack.

Key outputs

  • Annex IX registration and testing plan
  • Informed consent records
  • Testing results and final report
  • Module 10 AISDP evidence
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