Skip to main content

Technical Documentation Overview

Overview​

MedDO requires manufacturers to compile and maintain technical documentation demonstrating GSPR compliance. It is available to the NB during conformity assessment and to Swissmedic on request. 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Incomplete GSPR matrices without justification; outdated standard references; CER not reflecting current state of the art; PMS plan not updated to reflect post-market experience; missing or outdated SSCP.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.