Clinical Investigation Pathways
Standard Clinical Investigation (ClinO-MD)
The primary pathway. Requires Swissmedic authorisation + BASEC ethics approval before commencement. See Clinical Investigations (ClinO-MD).
First-in-Human Studies First-in-human investigations receive enhanced Swissmedic scrutiny. In addition to standard ClinO-MD requirements, applicants must submit: (1) comprehensive pre-clinical data supporting the safety basis for first human use; (2) a risk management file specifically addressing first-in-human risks, including analysis of vulnerable patient populations and monitoring of specific endpoints; and (3) a detailed safety monitoring plan with predefined stopping rules based on cumulative safety outcomes. Early engagement with Swissmedic during protocol development is strongly recommended to align expectations on safety data requirements and monitoring thresholds.
Expanded Access Within a Trial
Trial participants may continue receiving the investigational device after the formal protocol ends if: the investigation has demonstrated clinical benefit; the participant continues to need the device; the manufacturer continues to supply it; Swissmedic and ethics committee have been notified of the expanded access arrangement.
Compassionate Use of Investigational Devices
A patient who does not meet investigation inclusion criteria but has a serious unmet need may access an investigational device under TPA Art. 9 para. 4. This requires a separate compassionate use application to Swissmedic — it is not automatically covered by the investigation authorisation. The investigation sponsor and the treating physician must be involved.
Official Sources
AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.