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Swissmedic Guidance by Topic

Swissmedic publishes guidance documents and technical information sheets on its website. These represent Swissmedic's operational interpretation of MedDO/IVDO and are non-binding but practically important.

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For the complete, current list always refer directly to swissmedic.ch.

Classification and Scope​

  • Borderline and classification guidance — Swissmedic borderline opinions and published decisions
  • Custom-made devices — statement requirements and templates
  • Special device types — combination products, tissue-based devices

Technical Documentation and Conformity Assessment​

  • Technical documentation content expectations
  • Harmonised standards recognised by Swissmedic
  • Conformity assessment procedure guidance by class

Clinical Evidence and Investigations​

  • Clinical evaluation expectations — alignment with MDCG 2020-5/6
  • Clinical investigation application requirements — ClinO-MD guidance
  • BASEC coordination guidance

Vigilance and Post-Market​

  • Vigilance reporting — eVigilance portal user guide
  • FSCA guidance — field safety notice templates and examples
  • PMS and PSUR content expectations

Registration and DAPI​

  • DAPI registration portal user guidance
  • Documentation requirements by registration type
  • UDI registration guidance

Labelling​

  • Swiss language requirements (DE/FR/IT)
  • Symbol usage guidance (ISO 15223)
  • eIFU notification procedure

Official Sources​

Disclaimer

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