Clinical Investigations of Medical Devices in Switzerland – Swissmedic Regulatory Framework

Legal Basis and Scope

Clinical investigations of medical devices in Switzerland are governed by the Medical Devices Ordinance (MedDO), the Human Research Act (HRA), and the Clinical Trials Ordinance for Medical Devices (ClinO-MD). These regulations align closely with EU MDR 2017/745 requirements while incorporating Swiss-specific provisions. The framework applies to all clinical investigations involving medical devices intended to generate data for conformity assessment, performance evaluation, or post-market follow-up, with risk-based authorisation requirements. Klinische Prüfungen - Swissmedic

Authorisation Requirements

• Higher-risk investigations (Class IIb implantable, Class III, active devices for diagnosis/therapy) require Swissmedic authorisation in addition to ethics committee approval.
• Lower-risk investigations (most Class I and IIa) require only cantonal ethics committee approval and notification to Swissmedic.
• Investigational use of CE-marked devices outside the intended purpose may require authorisation depending on risk and deviation extent.

Applications must include the clinical investigation plan, investigator brochure, risk-benefit analysis, participant information, insurance coverage, and manufacturing information.

Good Clinical Practice (GCP) and Ethics

All clinical investigations must comply with international GCP standards (ISO 14155) and Swiss HRA principles. Key obligations include:

• Independent ethics committee review and approval.
• Informed consent in a language understandable to participants.
• Adequate participant insurance and compensation provisions.
• Data protection in accordance with Swiss and EU standards (FADP alignment).

Swissmedic may inspect sites and request corrective measures if non-compliance is identified.

Notification and Reporting Obligations

• Serious adverse events and device deficiencies must be reported promptly to Swissmedic and the ethics committee.
• Annual safety reports and progress updates are required for authorised studies.
• End-of-study reports and final results must be submitted, with publication encouraged in line with transparency requirements.

Transitional and Special Provisions

Investigations initiated under the old regime benefit from transitional arrangements. Special pathways exist for:

• Emergency use authorisations.
• Compassionate use / named-patient programmes.
• Investigations combining drugs and devices (coordinated with Swissmedic medicinal products division).

Practical Guidance

Swissmedic provides detailed application forms, checklists, guidance documents, and a dedicated contact point for clinical investigations. The authority also publishes lists of authorised investigations and annual statistics. Early consultation is recommended for complex or high-risk studies to clarify requirements and avoid delays.

This regulatory framework ensures rigorous scientific and ethical standards for clinical investigations in Switzerland, supporting safe innovation and reliable evidence for medical device performance and safety. Full details, forms, timelines, and contact information are available on the Swissmedic clinical investigations page. Klinische Prüfungen - Swissmedic