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Clinical Investigations (ClinO-MD)

Overview​

Clinical investigations of medical devices in Switzerland are governed by ClinO-MD (SR 810.305) — the Clinical Investigations Ordinance for Medical Devices. Clinical investigations require both Swissmedic authorisation and ethics committee approval via BASEC before they can commence.

When a Clinical Investigation is Required​

Clinical investigations are required when: clinical data from equivalent devices is unavailable or insufficient; the device is novel or incorporates new technologies; higher-risk device classes (Class III, implantable) require investigation-generated clinical data; the intended use differs significantly from existing clinical evidence.

Regulatory Framework​

ClinO-MD (SR 810.305) defines: investigation sponsor and investigator obligations; investigational device exemption conditions; adverse event reporting during investigations; documentation and record-keeping requirements; early termination and suspension procedures.

MedDO Art. 40–53 provides the framework authorisation requirements for clinical investigations.

Authorisation Process​

  1. Sponsor submits application to Swissmedic and simultaneously submits to BASEC for ethics (via Swissmedic's VISTA portal or by post) (Basler Ausschuss für Ethik in der Humanforschung) or the relevant regional ethics committee review. Parallel submission does not mean concurrent approval — both are independent processes.
  2. Swissmedic assesses the safety and technical aspects; issues authorisation or requests additional information
  3. BASEC coordinates ethics committee review across Switzerland's regional ethics committees
  4. Both authorisations must be received before the investigation commences
  5. Investigational devices may be supplied without full market registration during an approved investigation

Ongoing Obligations During Investigation​

  • Report suspected unexpected serious adverse device effects (SUSADEs) to Swissmedic and ethics committee promptly
  • Submit annual safety reports
  • Maintain investigation master file
  • Notify Swissmedic and ethics committee of protocol amendments requiring approval