Swissmedic Updates Information Sheet on IVD Performance Studies

Swissmedic has updated its information sheet “Performance studies of IVD”, version 5.5, valid from 10 July 2026.

The document is intended for sponsors of performance studies of in vitro diagnostic medical devices, contract research organisations and investigators.

It provides guidance on the approval process, sponsor reporting requirements and Swissmedic surveillance activities for IVD performance studies in Switzerland.

Scope of the Information Sheet

The information sheet applies to in vitro diagnostic medical devices and accessories, referred to as IVDs in the document.

Swissmedic clarifies that the document does not cover clinical investigations of medical devices that are not IVDs. For those studies, Swissmedic refers to a separate information sheet on clinical investigations of medical devices.

The document also refers sponsors to specific guidance for combined studies where an interventional IVD performance study and a clinical trial of a medicinal product or ATMP are conducted in parallel.

Legal Framework and ISO 20916

The information sheet summarises the Swiss legal framework applicable to IVD performance studies, including the Human Research Act, the Therapeutic Products Act, the Ordinance on Clinical Trials of Medical Devices and related Swiss ordinances.

Swissmedic also highlights the relevance of European requirements under the IVDR, as well as implementing regulations such as common specifications for certain Class D IVDs.

The document places particular emphasis on ISO 20916, which describes principles for clinical performance studies using specimens from human subjects. Sponsors are expected to address compliance with the standard and disclose any deviations in the clinical performance study plan, list of standards and Swissmedic approval application form.

Study Categories and Approval Requirements

Swissmedic explains the categorisation of IVD performance studies and the responsible authorities.

The document distinguishes between studies where an IVD is only used during a research project and studies where the IVD itself is under investigation.

For certain studies, submission to the ethics committee may be sufficient. However, Category C interventional performance studies may require approval from both Swissmedic and the ethics committee, including situations involving non-CE-marked IVDs, off-label use or prohibited IVDs.

The document also includes a decision tree to help determine whether submission to Swissmedic is required.

Swissmedic Review, Fees and Surveillance

For Category C interventional performance studies, Swissmedic describes the first submission process, validation, content review, approval and possible shortcomings.

The information sheet notes that Swissmedic may request additional information during or after the review and can only approve a performance study after ethics committee approval.

The flat-rate fees listed include CHF 5,000 for a regular review, CHF 1,500 for a simplified review and CHF 1,000 for a substantial modification. Additional work may be charged at CHF 270 per hour.

Swissmedic may also carry out inspections, covering performance studies of all ClinO-MD categories and all companies, institutions and persons involved.

Reporting Duties During Performance Studies

The information sheet sets out reporting and notification duties during IVD performance studies.

For Category C interventional performance studies, the document covers:

• substantial and non-substantial modifications;

• safety and protective measures;

• serious adverse events and device deficiencies;

• annual reporting;

• completion, interruption or premature termination of studies;

• final reports and lay summaries;

• radiation incidents, where applicable.

The document highlights specific timelines, including 7 days for reportable serious adverse events and device deficiencies with SAE potential, 24 hours for safety-related temporary halt or premature termination, and 15 days for notification of study completion in Switzerland.

SAE Reporting and Device Deficiencies

Swissmedic provides detailed guidance on the recording and reporting of adverse events and device deficiencies.

Sponsors must ensure that adverse events and device deficiencies are fully recorded and that case report forms collect the information needed to meet reporting obligations.

The document also notes that internationally standardised IMDRF Adverse Event Terminology is recommended for describing adverse events and device issues.

Impact on IVD Manufacturers and Sponsors

For IVD manufacturers, sponsors and CROs conducting performance studies in Switzerland, the updated information sheet reinforces the importance of early planning, correct study categorisation and robust quality systems.

Manufacturers and sponsors should pay particular attention to:

• determining whether Swissmedic approval is required;

• correct categorisation of Category A and Category C performance studies;

• ISO 20916 compliance and documented deviations;

• preparation of complete approval submissions;

• GSPR and standards documentation;

• SAE and device deficiency reporting processes;

• safety measures and risk mitigation planning;

• annual reporting and final report timelines;

• data retention requirements;

• Swiss agent requirements for sponsors based abroad.

For IVD manufacturers and study sponsors, the document highlights that Swiss performance study requirements involve both regulatory approval and ongoing operational compliance throughout the study lifecycle.