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Technical Documentation Overview

Overview​

MedDO requires manufacturers to compile and maintain technical documentation demonstrating GSPR compliance. It must be available to the NB during conformity assessment and to Swissmedic upon request during market surveillance or conformity assessment activities. It consists of: Annex II (general technical documentation) and Annex III (post-market follow-up documentation).

MedDO Annex II — General Technical Documentation​

  1. Device description and specification — name, model numbers, intended purpose, indications, contraindications, accessories, variants
  2. Information supplied — labelling, IFUs, website claims, promotional materials
  3. Design and manufacturing information — design drawings, BOM, manufacturing flow, sterilisation method, outsourced operations
  4. GSPR compliance documentation — compliance matrix mapping each applicable GSPR to evidence
  5. Risk-benefit analysis and risk management — risk management file (ISO 14971)
  6. Verification and validation — pre-clinical test reports, biocompatibility, electrical safety, software validation, sterility, shelf-life
  7. Clinical evaluation — CER per MedDO Annex XIV — see Clinical Evaluation Overview

MedDO Annex III — Post-Market Follow-Up Documentation​

  • Post-market surveillance plan
  • PSUR or PMS report (depending on device class)
  • PMCF plan and PMCF report

Retention Obligations​

  • 10 years after last device placed on market (general devices)
  • 15 years (implantable devices)

Common NB Audit Findings​

Incomplete GSPR matrices without justification; outdated standard references; CER not reflecting current state of the art; PMS plan not updated to reflect post-market experience; missing or outdated SSCP.

Official Sources​

Disclaimer

AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.

Swissmedic retains the right to request technical documentation during market surveillance activities and post-market investigations to verify continued compliance with MedDO requirements. All documentation must be made available within the timeframe specified by Swissmedic.