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Technical Documentation

Indian technical documentation requirements are based on the IMDRF STED (Summary Technical Documentation) format.

Core technical file contents​

  • Device description and intended use;
  • Summary of design and manufacturing;
  • Essential Principles checklist (Schedule 4, MDR 2017);
  • Risk management file (ISO 14971);
  • Pre-clinical and clinical performance data;
  • Labelling specimens;
  • Post-market surveillance plan.

Official source: Medical Devices Rules 2017, Schedule 4; IMDRF STED guidance

Essential Principles in Indian Context:

Schedule 4 of the Medical Devices Rules 2017 lists Essential Principles that all devices must comply with. These cover safety and performance, design and development, risk management, production and post-production, clinical evaluation, labelling and instructions, and post-market surveillance. A completed Essential Principles checklist must demonstrate how the device addresses each principle or provide justified exclusions.