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. Life-threatening events must be reported within 24 hours; other serious adverse events must be reported within 7 calendar days. Expedited reporting may be required in certain circumstances.

Official Sources

• ClinO-MD (SR 810.305) — Fedlex (EN)
• Swissmedic — Clinical investigations
• BASEC — Ethics review

Disclaimer

AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.

Key Requirements

Timelines

Swissmedic typically assesses clinical investigation applications within 30 days of a complete submission. BASEC ethics committee review timelines vary by committee but typically require 4–6 weeks. Both approvals must be obtained before the investigation can commence. Sponsors should coordinate applications to both Swissmedic and BASEC simultaneously to allow parallel review.