Swissmedic Updates Guidance on Combined Studies Involving Medicines and Medical Devices
Swissmedic has updated its information sheet “Combined studies”, identified as BW600_00_017.
Version 4.0 is valid from 28 September 2026 and is intended for sponsors, contract research organisations and investigators conducting studies that combine medicinal products or advanced therapy medicinal products with medical devices or in vitro diagnostic medical devices. 1790741926165
The latest revision adds a specific clarification concerning amendments affecting the medical device or IVD aspect of a combined study. 1790741926165
What Is a Combined Study?
Swissmedic uses the term “combined study” for studies involving:
a clinical trial of a medicinal product or ATMP in parallel with an interventional IVD performance study;
a clinical trial of a medicinal product or ATMP in parallel with a clinical investigation of a medical device. 1790741926165
The term is not yet formally defined in Swiss or European legislation, but is used operationally in the information sheet.
Examples of Combined Studies
Swissmedic gives several examples of studies that may require a combined study approval procedure, including:
an unlicensed ATMP used with a non-CE-marked drug pump;
a non-CE-marked IVD used to identify a biomarker determining patient selection for an unlicensed medicinal product;
implantation of a non-CE-marked hydrocephalus shunt together with off-label use of an antiemetic medicinal product. 1790741926165
These examples illustrate how medicinal product and device regulatory requirements can apply simultaneously within a single research project.
One Coordinated Swissmedic Process
The process overview on page 3 shows that Swissmedic aims to coordinate the different regulatory aspects of a combined study.
The model includes:
one study documentation package;
synchronised review of medical device and medicinal product aspects;
one consolidated Swissmedic request for further information;
one sponsor response covering relevant questions;
one Swissmedic decision containing both device and medicinal product aspects. 1790741926165
Swissmedic also operates a Single Point of Contact (SPoC) through the Medical Devices Clinical Investigations unit for administrative and procedural matters.
Applicable Regulatory Frameworks
Combined studies must comply simultaneously with the legal and technical requirements applicable to both sides of the study.
Swissmedic refers to:
ClinO;
ClinO-MD;
Regulation (EU) 536/2014;
MDR;
IVDR;
ICH GCP;
ISO 14155;
ISO 20916. 1790741926165
Where requirements differ between the applicable frameworks, Swissmedic states that the requirements of both regulatory regimes must be fulfilled.
Which Combined Studies Require Swissmedic Approval?
Swissmedic states that approval as a combined study is required where a study combines:
a Category B or C clinical trial of a medicinal product or ATMP; and
a Category C clinical investigation of a medical device or performance study of an IVD. 1790741926165
Sponsors should contact the cantonal ethics committee where there is uncertainty about categorisation.
Parallel Submission to Swissmedic and Ethics Committee
A key procedural requirement is that combined studies must be submitted in parallel to Swissmedic and the responsible cantonal ethics committee on the same day. 1790741926165
For Swissmedic, the sponsor submits one eDok package through the eGov Service eMessage portal to the SPoC.
Different delivery types apply depending on whether the combined study includes a medical device or an IVD. 1790741926165
Submission Package Structure
The eDok structure separates the device and medicinal product aspects.
Swissmedic specifies that:
folders 00.00–17.00 contain the MD or IVD documentation;
folder 18.00 contains the MP or ATMP documentation. 1790741926165
Sponsors are also instructed not to add, delete or rename folders in the standardised structure.
Incomplete Applications Are Not Accepted
Swissmedic notes that incomplete combined study submissions will not be accepted.
Examples include situations where:
required preclinical analytical performance testing for an IVD is not yet available;
an investigator’s brochure for a non-CE-marked medical device is missing. 1790741926165
Where one part of a project is ready before another, sponsors may instead consider sequential initiation.
Sequential Initiation of a Project
The guidance explains how studies may begin before all components are ready.
Where only one regulatory aspect is complete, sponsors may first seek approval for that component and later transition to a combined study once the second component becomes ready. 1790741926165
Swissmedic makes clear that it is not possible to submit an application for a combined study containing only part of the required documentation.
Review and Approval
The relevant Swissmedic experts assess the medicinal product and device aspects of the combined study.
Swissmedic may issue RFIs during review. However, under ClinO-MD, Swissmedic can only issue its final approval once the responsible cantonal ethics committee has approved the project. 1790741926165
The final Swissmedic approval letter includes both:
approval of the MP/ATMP clinical trial;
approval of the MD/IVD clinical investigation or performance study.
Confidential Documentation
The guidance also provides a specific procedure where some documents cannot be accessed by the main applicant because of confidentiality restrictions.
Such documents may be submitted separately, but the main cover letter must identify the affected documents and anticipated additional submissions.
Swissmedic only begins the formal review once all parts of the submission have been received and the file is complete. 1790741926165
Amendments to Combined Studies
Modifications may affect:
the MP/ATMP aspect;
the MD/IVD aspect;
both aspects.
Where both are affected, they may be submitted together in one eDok and Swissmedic can approve them in a single letter. 1790741926165
For urgent and non-urgent changes, Swissmedic prefers separate applications where one modification needs to be implemented earlier.
New Clarification in Version 4.0
The main change in version 4.0 concerns the assessment of amendments affecting the medical device or IVD aspect.
Swissmedic clarifies that this assessment should not be limited only to changes to the device itself, its CE marking or newly identified device-related risks.
Sponsors should also consider whether changes to elements such as:
informed consent documents;
study sites;
eligibility criteria;
follow-up assessments;
endpoints;
other study elements
may affect the MD or IVD aspect of the combined study. 1790741926165
This is the key substantive update highlighted in the version history. 1790741926165
One Amendment Across Multiple Studies
Where the same investigational medicinal product or ATMP is used in several combined studies, the guidance allows certain identical amendments to be submitted together, provided the sponsor and Swiss representative are the same across the affected studies.
Depending on the situation, sponsors may submit either:
one consolidated eDok;
separate eDoks for each combined study. 1790741926165 1790741926165
Swissmedic notes that it will only charge once for review where the applicable conditions for a consolidated amendment are fulfilled.
When an Existing Study Becomes a Combined Study
An existing clinical trial may need to transition to the combined-study procedure.
Examples include:
a medical device or IVD losing conformity;
addition of a non-conforming device or IVD to a medicinal product trial;
addition of an unlicensed medicinal product or ATMP to an existing device investigation or IVD performance study. 1790741926165 1790741926165
In these cases, the study documentation must be updated to reflect both regulatory aspects.
Reporting Duties
Combined studies are subject to the reporting requirements applicable to both medicinal product and medical device clinical research.
Swissmedic states that:
ClinO reporting requirements apply to MP/ATMP aspects;
ClinO-MD reporting requirements apply to MD/IVD aspects;
the applicable timelines and definitions for both frameworks must be respected. 1790741926165
Because the two aspects may have different durations, some reporting obligations may end before the entire combined study is completed.
Annual Reports and DSURs
Sponsors may submit:
separate annual reports for each study aspect; or
one combined annual report.
Where one report is used, it must contain the necessary information for both regulatory components. 1790741926165
Completion, Termination or Interruption
Where all aspects of the study end, sponsors must notify Swissmedic and submit the appropriate final documentation.
A final report is generally due within one year after completion.
For a temporary halt or premature termination relating to the MD/IVD aspect, the final report is due within three months. 1790741926165
When Only One Aspect Ends
Where one regulatory aspect ends before the other, the remaining component continues as a standard medicinal product trial or device/IVD study.
Swissmedic does not issue a new approval letter solely because one aspect has ended.
The project nevertheless remains classified as a combined study until all sponsor reporting obligations for the completed component have been fulfilled. 1790741926165
Adverse Events and Device Deficiencies
Sponsors must apply seriousness criteria under both the medicinal product and device frameworks.
Swissmedic requires reporting procedures for both clinical trial types to be followed. 1790741926165
The guidance contains additional considerations for companion diagnostics (CDx).
These include handling of adverse events, device deficiencies, sample quality issues, re-testing, changes to relatedness assessments and corrective or preventive actions. 1790741926165
Safety Measures
Safety-related submissions include:
premature termination or temporary halt for safety reasons;
safety and protective measures;
urgent safety measures.
Sponsors must identify which aspect of the combined study is affected — MP/ATMP, MD/IVD or multiple. 1790741926165
Separate procedures remain applicable for SUSAR reporting and certain ATMP-related safety events.
Impact on Sponsors and Clinical Research Organisations
For sponsors, CROs, investigators and regulatory teams managing combined studies in Switzerland, version 4.0 reinforces the need for close coordination between medicinal product and device regulatory workstreams.
Stakeholders should pay particular attention to:
correct classification of combined studies;
same-day parallel submission to Swissmedic and the ethics committee;
use of the Swissmedic SPoC;
complete eDok preparation;
distinction between MP/ATMP and MD/IVD aspects;
sequential initiation strategies;
confidentiality procedures;
coordinated amendments;
the broader assessment of whether an amendment affects the MD/IVD aspect;
dual reporting obligations;
CDx-specific safety reporting;
management of study completion where different aspects end at different times.
The central compliance message is that combined studies should be managed as an integrated project while simultaneously satisfying the full regulatory requirements applicable to both medicinal products and medical devices or IVDs.
