Swissmedic Updates Information Sheet on Performance Studies of IVD
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 Swissmedic surveillance activities.
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.
Scope and Regulatory Framework
Swissmedic explains that the information sheet is valid under the new regulation that came into force on 26 May 2022.
The document refers to Swiss legal requirements, 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.
It also notes that Swiss requirements extensively refer to the European In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 and relevant implementing regulations.
ISO 20916 and Study Planning
The information sheet highlights ISO 20916, which describes principles for clinical performance studies of IVD using specimens from human subjects.
According to Swissmedic, 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
Swissmedic explains the different categories of IVD performance studies and the responsible authorities.
The document includes a decision tree to help determine whether a 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. Swissmedic also describes the process for first submissions, validation, review, approval, shortcomings, fees and confidentiality restrictions.
The document also includes information on simplified review, which may be available for certain category C1 or C2 studies involving class A or B IVDs, provided specific conditions are met.
Reporting Duties and Surveillance
The information sheet sets out reporting and notification duties during performance studies.
For category C interventional performance studies, the document addresses:
substantial and non-substantial modifications;
safety and protective measures;
serious adverse events;
device deficiencies;
annual reports;
completion, interruption or premature termination of studies;
reporting timelines and 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 the 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 early regulatory planning and complete submissions.
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;
documentation of applicable standards and GSPR information;
timely submission to Swissmedic and ethics committees;
reporting duties for SAEs and device deficiencies;
risk mitigation measures and 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, regulatory submissions or pre-market evaluation.
