🇨🇭Switzerland Medical Device Regulations

Swiss Database on Medical Devices

Swiss medical device database. Voluntary registration from August 2025; mandatory registration from July 1, 2026. Transition period until December 31, 2026.

Amended Ordinance on In Vitro Diagnostic Medical Devices

Incorporates EU IVD transition timelines into Swiss law. Simplified designation for non-self-testing IVDs now indefinite from January 1, 2025.

Ordinance on In Vitro Diagnostic Medical Devices

Swiss ordinance for IVD medical devices aligned with EU IVDR. Establishes classification (Class A, B, C, D), performance evaluation, and transition timelines aligned with EU.

Medical Devices Ordinance

Core Swiss ordinance for medical devices aligned with EU MDR. Establishes classification (Class I, IIa, IIb, III), conformity assessment, Swiss Rep requirements, and CHRN marking.

Medical Device Classification Rules

Classification follows EU MDR rules. Devices categorized into Class I, IIa, IIb, III based on intended purpose and risk. Different conformity assessment procedures apply per class.

Ordinance on Clinical Trials with Medical Devices

Requirements for clinical trials with medical devices in Switzerland. Aligned with EU MDR clinical investigation requirements and Human Research Act.

Swiss Authorized Representative Requirements

Foreign manufacturers must appoint a Swiss Authorized Representative (Swiss Rep) to place medical devices on Swiss market. Swiss Rep assumes regulatory responsibilities.

Materiovigilance and Incident Reporting

Manufacturers must report serious incidents and field safety corrective actions to Swissmedic. Post-market surveillance system required under Article 56 MedDO.

Conformity Certificates and Validity

Conformity certificates valid for maximum 5 years. Extended following re-assessment. Recognized conformity assessment bodies must be designated.

Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act)

Primary Swiss law governing therapeutic products including medical devices. Establishes Swissmedic authority, market surveillance, and penalty provisions.