Swissmedic Updates Information Sheet on IVD Performance Studies
Swissmedic has updated its information sheet “Performance studies of IVD”, version 5.4, valid from 8 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 surveillance by Swissmedic.
The information sheet applies to in vitro diagnostic medical devices and accessories, referred to as IVD in the document. It does not cover clinical investigations of medical devices that are not IVD.
Regulatory Framework
The information sheet is valid under the new regulation that came into force on 26 May 2022.
Swissmedic refers to several Swiss legal texts applicable to performance studies of IVD, including the Human Research Act, the Therapeutic Products Act, the Ordinance on Clinical Trials of Medical Devices, the Human Research Ordinance and the Swiss Ordinance on In Vitro Diagnostic Medical Devices.
The document also notes that Swiss requirements refer extensively to the European In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 and related implementing regulations.
ISO 20916 and Study Planning
Swissmedic highlights ISO 20916, which describes principles for clinical performance studies of IVD using specimens from human subjects.
According to the information sheet, sponsors must address compliance with ISO 20916 and disclose any deviations in the clinical performance study plan, the list of standards and the Swissmedic approval application form.
Approval of IVD Performance Studies
The document explains the different study categories and responsible authorities in Switzerland.
It includes a decision tree to help determine whether a performance study must be submitted to Swissmedic, the ethics committee, or both.
For category C interventional performance studies, applications must be submitted to Swissmedic and the ethics committee on the same day. The guidance also covers first submissions, validation, review and approval, shortcomings, fees and submissions affected by confidentiality restrictions.
Swissmedic also describes the conditions under which a simplified review may be requested for certain category C1 or C2 studies involving class A or B IVDs.
Reporting Duties and Surveillance
The information sheet sets out reporting and notification duties during IVD performance studies.
For category C interventional performance studies, the document addresses:
modifications and amendments;
safety and protective measures;
serious adverse events;
device deficiencies;
annual reports;
completion, interruption or premature termination;
reporting timelines and applicable Swissmedic forms.
Swissmedic states that reportable serious adverse events and device deficiencies with serious adverse event potential must be reported to Swissmedic within 7 days.
The document also notes that Swissmedic may conduct inspections and may withdraw or suspend an approval, or make continuation of a study dependent on additional conditions.
Impact on IVD Manufacturers and Sponsors
For IVD manufacturers, sponsors, CROs and investigators conducting performance studies in Switzerland, the updated information sheet reinforces the importance of structured regulatory planning and complete documentation.
Manufacturers and sponsors should pay particular attention to:
correct categorisation of IVD performance studies;
whether Swissmedic approval is required;
alignment with ISO 20916;
preparation of the clinical performance study plan;
applicable standards and GSPR information;
timely submissions to Swissmedic and ethics committees;
SAE and device deficiency reporting;
risk mitigation measures;
quality assurance systems;
requirements for sponsors based outside Switzerland.
For IVD manufacturers developing products for the Swiss market, the document is particularly relevant where performance studies are used to support clinical performance evidence, pre-market evaluation or regulatory submissions.
