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Swissmedic Guidance by Device Class

Class I (including Im, Is, Ir)​

  • Self-declaration procedure and Annex IV compliance
  • Class Im — metrological requirements; METAS interface
  • Class Is — sterility aspects; NB involvement scope
  • Class Ir — reprocessing information requirements (ISO 17664)

Class IIa​

  • Conformity assessment route options (Annex IX vs X+XI)
  • PSUR requirements (at least every 2 years)
  • PMCF plan requirements and when PMCF can be omitted

Class IIb​

  • Annual PSUR requirements
  • Technical documentation assessment scope under Annex IX
  • Vigilance reporting frequency and obligations

Class III​

  • SSCP requirements and NB validation process
  • Design examination (Annex IX Chapter II) expectations
  • Clinical evidence requirements — when equivalence is acceptable

IVD — List A​

  • NB involvement requirements (QMS audit + Chapter II technical documentation assessment)
  • Performance study design and data expectations
  • Annual PMPF obligations

IVD — List B​

  • NB QMS audit requirements
  • Performance evaluation data expectations
  • Biennial PMPF requirements

IVD — Self-test​

  • Usability evaluation requirements for lay persons
  • Plain language IFU requirements
  • Near-patient testing considerations

IVD — General​

  • Self-declaration procedure
  • Minimum performance evaluation data

Official Sources​

Disclaimer

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