During category C clinical trials, sponsors have various authorisation and reporting obligations towards Swissmedic.
An application for authorisation has to be submitted to Swissmedic in the following cases:
- Changes to the medical device or its administration or use;
- Changes as a result of new preclinical and clinical data that could affect the safety of the device, or.
- Changes regarding the manufacturing of the medical device that could affect its safety.
- Change of sponsor.
The following must be reported to Swissmedic:
- Reportable serious adverse events (SAE), incl. possible serious device deficiencies.
- Safety and protective measures.
- An annual safety report comprising an updated written report and the list of SAEs incl. device deficiencies covered by the report must be submitted.
- Changes to the trial and documents that do not require authorisation.
- Completion, discontinuation or interruption of the trial and final report.
For more detailed information, see section 7 of Information sheet BW510_00_001e_MB.
The procedures and documents prepared to satisfy the reporting obligations must be described in the trial investigation plan and recorded in the case report forms. These documents are reviewed during the Swissmedic authorisation procedure.
Incidents that occur during category A trials (trials not subject to Swissmedic authorisation) are subject to the reporting obligations for materiovigilance.