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What Must Be Reported

Overview​

Manufacturers (and CH REPs acting on their behalf) must report serious incidents and field safety corrective actions (FSCAs) to Swissmedic under MedDO Art. 66–68. These are mandatory reporting obligations — failure to report is an offence under the TPA.

Serious Incidents (Art. 66)​

A serious incident is any malfunction or deterioration in the characteristics or performance of a device made available on the market, any inadequacy in the labelling or IFU, or any use error that — directly or indirectly — has led to, or could lead to:

  • The death of a patient, user, or other person
  • A serious deterioration in health of a patient, user, or other person, including:
    • A life-threatening illness or injury
    • Permanent impairment of a body structure or function
    • Hospitalisation or prolonged hospitalisation
    • Medical or surgical intervention required to prevent life-threatening illness/permanent impairment
    • Chronic disease
    • Foetal distress, foetal death, or congenital physical or mental impairment

A serious incident also includes near-serious incidents that could have led to the above outcomes but for a lucky or chance circumstance.

What Does NOT Need to Be Reported​

  • Device malfunction or deterioration where the device did not reach the patient
  • Technical complaints with no patient safety impact
  • Device defects identified before market placement

FSCAs​

Field safety corrective actions are reported separately from serious incidents — see FSCA Process.

Official Sources​

Disclaimer

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