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Compassionate Use

Overview​

Compassionate use allows seriously ill patients to access unregistered medical devices where no comparable registered therapy exists and the benefit-risk balance is favourable. Legal basis: TPA Art. 9 para. 4.

Eligibility Conditions​

Swissmedic may authorise compassionate use where:

  • Patient has a life-threatening, severely debilitating, or serious condition
  • No comparable registered therapy is available in Switzerland
  • Available clinical data supports a favourable benefit-risk balance for this patient population
  • A motivated application is submitted by the treating physician

Authorisation Process​

  1. Treating physician (or manufacturer/CH REP supporting the physician) submits application to Swissmedic
  2. Application includes: patient details (anonymised); diagnosis and treatment history; device description; available clinical/pre-clinical data; risk-benefit assessment
  3. Swissmedic reviews and issues authorisation (or rejection) — typically weeks; urgent cases handled faster
  4. Device supplied to the named patient following authorisation

Reporting Obligations​

Serious adverse events during compassionate use must be reported to Swissmedic via eVigilance. Swissmedic may request follow-up data.

Official Sources​

Disclaimer

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