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
Enhanced Swissmedic scrutiny applies. Additional documentation required: comprehensive pre-clinical data supporting safety basis for first human use; risk management file specifically addressing first-in-human risks; detailed safety monitoring plan with predefined stopping rules. Engage Swissmedic early in the planning process.
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.