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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

Risk management must be conducted in accordance with ISO 14971:2019 (Medical devices — Application of risk management to medical devices). The risk management file must document: (1) Risk analysis identifying hazards and hazardous situations; (2) Risk evaluation assessing severity and probability; (3) Risk control measures and verification; (4) Residual risk evaluation; (5) Risk management review; (6) Production and post-production information management. The risk management file must demonstrate that risks are reduced to an acceptable level and that benefits outweigh residual risks.