Combined Drug-Device Clinical Studies in Switzerland – Swissmedic Coordination Process

Regulatory Context

Clinical studies involving both a medicinal product and a medical device (drug-device combination studies) fall under the scope of the Therapeutic Products Act (TPA). Depending on the primary mode of action and study design, different regulatory pathways apply:

• Studies primarily evaluating the medicinal product (drug-led) are assessed under the Clinical Trials Ordinance (ClinO).
• Studies primarily evaluating the medical device (device-led) follow the Clinical Trials Ordinance for Medical Devices (ClinO-MD).
• When both components are substantially investigated, a coordinated procedure is required to avoid duplicate assessments and ensure consistent requirements.

Swissmedic's medicinal products and medical devices divisions collaborate to provide a single point of contact and harmonised decisions. Kombinierte Studien - Swissmedic

When Coordination is Required

Coordination applies when the study protocol investigates:

• Both the pharmacological properties of the medicinal product and the performance/safety of the device.
• Interactions between the drug and device components.
• Use of an integral drug-device combination product where both aspects are critical.

If the device is only an administration aid (e.g., syringe for injection) with no independent performance claims, the study is typically handled solely under ClinO without coordination.

Application and Submission Process

• Single Application Portal: Submit via the Swissmedic e-Business portal (medicinal products or medical devices section, depending on primary focus).
• Joint Dossier: Include all required elements for both regulations (e.g., IMPD for drug, CIP for device, investigator brochure covering both components).
• Risk-Based Routing: The applicant indicates the primary focus; Swissmedic may re-route or confirm the coordination need during validation.
• Timelines: Combined assessment follows the longer of the ClinO or ClinO-MD timelines, with parallel ethics committee review.

Assessment and Authorisation

• Joint Review: Medicinal products division evaluates drug-related aspects (quality, non-clinical, clinical data); medical devices division assesses device performance, risk management, and usability.
• Harmonised Decisions: Swissmedic issues a coordinated authorisation/approval decision, ensuring consistent conditions (e.g., labelling, safety reporting).
• Ethics Committee: Cantonal ethics committee approval remains required in parallel.

Reporting and Safety Obligations

• Adverse events and device deficiencies are reported according to the applicable ordinance (ClinO for drug-led, ClinO-MD for device-led).
• Serious incidents involving the combination are notified to both divisions.
• Annual safety reports and end-of-study reports cover both components.

Practical Advice

Applicants should contact Swissmedic early (pre-submission meeting recommended) to clarify classification, primary pathway, and dossier requirements. Swissmedic publishes guidance on borderline cases, submission checklists, and examples of combined studies. This coordinated approach reduces administrative burden while maintaining high standards for safety and scientific validity.

The process supports innovative combination products in Switzerland, facilitating efficient development and market access for advanced therapies. Detailed requirements, contact points, and application guidance are available on the Swissmedic combined studies page. Kombinierte Studien - Swissmedic