Clinical Investigations Ordinance (ClinO-MD)
Overview
The Clinical Investigations Ordinance for Medical Devices (ClinO-MD, SR 810.305) governs the conduct of clinical investigations of medical devices in Switzerland. It entered into force in May 2021, aligned with MedDO. ClinO-MD is the Swiss equivalent of EU MDR Annex XV (clinical investigation requirements).
Scope
ClinO-MD applies to:
- First-in-human studies with investigational medical devices
- Studies to generate clinical evidence for conformity assessment purposes
- Post-market clinical investigations (if conducted under the ClinO-MD framework)
- Studies with devices that are CE-marked but used outside their intended purpose
Key Requirements
Sponsor obligations: The sponsor (manufacturer or delegated CRO) is responsible for authorisation application, ethics submission, trial conduct, adverse event reporting, and trial master file maintenance.
Swissmedic authorisation: Required for all clinical investigations. Swissmedic assesses the scientific and safety aspects. Application must be submitted simultaneously with the BASEC ethics submission.
BASEC ethics approval: All clinical investigations require ethics committee approval coordinated through BASEC. Both Swissmedic authorisation and ethics approval must be received before the investigation starts.
Adverse event reporting: SUSADEs (Suspected Unexpected Serious Adverse Device Effects) must be reported to Swissmedic and the ethics committee within defined timeframes (24 hours for life-threatening events).
Official Sources
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