Swissmedic Publishes Swiss Good Practice for IVD Materiovigilance
Swissmedic, together with the Swiss Union of Laboratory Medicine (SULM) and the Foederatio Analyticorum Medicinalium Helveticorum (FAMH), has developed the Swiss Good Practice for Materiovigilance in In-Vitro Diagnostics, GPMV-IVD.
The document is version 1.00 of 2026 and is titled “Schweizerische Gute Praxis der Materiovigilance in der In-vitro-Diagnostik (GPMV-IVD)”.
Purpose of the Guidance
The GPMV-IVD is intended to support professionals in laboratories, hospitals and point-of-care testing (POCT)settings in their daily work with in-vitro diagnostics.
The foreword explains that the document helps users understand how serious incidents involving IVDs should be identified, assessed and reported, and how Field Safety Corrective Actions (FSCA) can be implemented efficiently.
The document combines binding legal requirements with practical recommendations, clearly distinguishing what must be followed from good-practice support tools.
Patient Safety Focus
The guidance places patient safety at the centre of IVD materiovigilance.
It notes that even small irregularities can have significant consequences and that reporting helps identify systematic risks early, improve processes and strengthen diagnostic quality over time.
Swissmedic receives reports, analyses serious incidents and supports the implementation of FSCA. The document emphasizes that complete and timely reports from healthcare institutions are essential for this oversight role.
Scope and Target Audience
The GPMV-IVD is addressed to professionals involved in the laboratory order-handling process, including POCT.
It explains IVD materiovigilance and aims to facilitate compliance with legal requirements.
The guidance is primarily aimed at laboratories, including hospital laboratories, medical contract laboratories, blood donation service laboratories and other diagnostic laboratories. It also covers IVD use in POCT performed near or directly at the patient.
Legal Basis
The GPMV-IVD was developed on the basis of the Swiss Ordinance on In-Vitro Diagnostics, IvDV, in connection with the EU In Vitro Diagnostic Medical Devices Regulation, EU IVDR.
The document states that users must follow the currently valid laws and ordinances and ensure they are using the latest version published by Swissmedic.
The guidance applies to Switzerland and Liechtenstein under the relevant customs union context.
Serious Incident Reporting
The guidance explains that healthcare professionals are legally required to report serious incidents involving IVDs to two recipients: Swissmedic and the supplier.
The report to Swissmedic creates the basis for regulatory oversight, while the supplier and manufacturer pathway supports root cause analysis and corrective actions.
The GPMV-IVD also states that serious incidents must be reported even if the affected IVD is no longer available to the manufacturer for root cause analysis.
Reporting Process
The reporting process should be defined within the healthcare institution.
The guidance explains that, in hospitals, the medical device vigilance contact person is responsible for reporting to Swissmedic. Reports to Swissmedic are made using the Swissmedic user reporting form, and all patient data must be anonymised for data protection reasons.
For reports to Swissmedic, the document highlights the importance of including product information such as trade name, product type, model or catalogue number, serial or lot number, full UDI where applicable, product availability and confirmation that the supplier has been informed.
Reporting Timelines
The GPMV-IVD sets out the applicable reporting deadlines for serious incidents.
Reports must be submitted without delay once the professional identifies or suspects a causal link between the product and the serious incident. The deadlines are:
immediately, and no later than 2 days, when there is a serious public health threat;
immediately, and no later than 10 days, for serious incidents that led to death or an unforeseen serious deterioration in health;
immediately, and no later than 15 days, for all other serious incidents.
Field Safety Corrective Actions and Field Safety Notices
The guidance explains that a Field Safety Corrective Action, FSCA, is a manufacturer action taken for technical or medical reasons to prevent or reduce the risk of a serious incident involving products placed on the market.
A Field Safety Notice, FSN, is the communication used by the manufacturer to inform affected users or customers about an FSCA.
The document states that healthcare institutions are strongly encouraged to review and implement the measures described in an FSN when they are affected. Failure to implement FSN measures may, depending on the situation, breach due diligence or maintenance obligations.
QMS Integration
The GPMV-IVD places strong emphasis on integrating materiovigilance into a quality management system, QMS.
The guidance states that hospitals and hospital laboratories must implement materiovigilance within an established QMS, while other laboratories are strongly encouraged to do so.
It also recommends that all laboratories establish processes for reporting serious incidents and managing FSNs, even where certain IvDV requirements are legally mandatory only for hospitals.
Materiovigilance Concept
The document provides an example structure for a materiovigilance concept.
Suggested elements include definitions, roles and responsibilities, interfaces, reporting system, reporting timelines, handling of FSNs, training concept, documentation of incidents and FSNs, and record retention.
This supports laboratories in building internal processes that are clear, documented and aligned with legal and practical expectations.
Product Traceability
Traceability is presented as an integral part of the QMS.
The guidance explains that traceability should make it possible to identify when and by whom a product was ordered, who the manufacturer is, which supplier provided it, relevant product data such as catalogue number, serial number, lot number, UDI and software or firmware version, where the product is stored, and by whom and when it was used for a patient.
The document also states that healthcare institutions must record and store the UDI of acquired products, preferably electronically.
Documentation and Training
The guidance explains that documentation should include serious and non-serious incidents, the assessment of reportability, the decision not to report where applicable, the dates on which Swissmedic and the supplier were informed, and feedback from the manufacturer’s investigation.
The GPMV-IVD also recommends a training concept to ensure relevant personnel can identify incidents and serious incidents, understand reporting procedures and manage FSNs. Training should cover topics such as what qualifies as an IVD, what materiovigilance is, what a serious incident is, reporting criteria, internal reporting channels, affected product storage and the Swissmedic reporting form.
Impact on Laboratories and IVD Stakeholders
For laboratories, hospitals, POCT settings and quality teams in Switzerland and Liechtenstein, the GPMV-IVD is an important practical reference for implementing IVD materiovigilance.
Stakeholders should pay particular attention to:
identification of IVDs and in-house IVDs;
serious incident criteria;
reporting to Swissmedic and suppliers;
reporting timelines;
anonymisation of patient data;
product information and UDI capture;
internal reporting workflows;
FSCA and FSN handling;
QMS integration;
product traceability;
staff training;
documentation and record retention;
roles and responsibilities within laboratories and hospitals.
For organisations using IVDs, the key message is that materiovigilance is not only a reporting obligation. It is a patient safety process that depends on timely reporting, complete product data, clear internal responsibilities, effective FSN implementation and strong integration into the laboratory QMS.
