Swissmedic Updates Hospital Materiovigilance Inspection Checklist for Medical Devices and IVDs
Swissmedic has updated its checklist for materiovigilance inspections in hospitals, covering vigilance requirements for medical devices, including in vitro diagnostic devices (IVDs).
The checklist is dated 10 September 2026, while the document identifies itself as Version 3.1 dated 23 September 2026. 1791440753927 1791440753927
The document is designed to support inspections of hospital materiovigilance systems and is structured around Swissmedic’s Good Practice for Materiovigilance in Hospitals (GPMV-Spital), 2026 edition.
Scope of the Checklist
The checklist applies to all medical devices, including IVDs, used within hospitals and falling within the scope of the Swiss Medical Devices Ordinance (MedDO/MepV) and In Vitro Diagnostic Medical Devices Ordinance (IvDO/IvDV). 1791440753927
It covers four main areas:
quality management systems for materiovigilance;
reporting of serious incidents;
management of Field Safety Notices and Field Safety Corrective Actions;
staff training and materiovigilance knowledge.
Quality Management System for Materiovigilance
Swissmedic expects healthcare institutions to establish a structured quality management framework for materiovigilance.
The checklist verifies whether:
relevant legislation and current vigilance guidance have been identified and applied;
management supports vigilance processes and provides sufficient resources;
quality objectives have been defined;
roles and responsibilities are documented;
materiovigilance processes, documentation and training are integrated into the quality system. 1791440753927
Document Retention Requirements
The checklist places particular emphasis on record retention.
Records and documents generated within the materiovigilance quality management system should be retained for at least 15 years.
Information and relevant documentation relating to medical devices should be retained for 20 years, including UDI information and documentation demonstrating appropriate implementation of FSCA measures. 1791440753927
Integration With Other Vigilance Systems
Hospitals should define interfaces between materiovigilance and other safety systems, including:
pharmacovigilance;
haemovigilance;
radiation protection;
cybersecurity;
critical incident reporting systems (CIRS). 1791440753927
This reflects Swissmedic’s expectation that medical device vigilance should be integrated into the wider hospital safety and governance framework.
Vigilance Contact Person
The checklist requires hospitals to appoint a Vigilance Contact Person and notify Swissmedic accordingly.
Where appropriate, two contact persons may be designated, including one specifically responsible for IVDs.
The designated person should have appropriate medical or technical training, sufficient time to fulfil the role and appropriate arrangements for substitution or backup. 1791440753927
Materiovigilance Committee
Swissmedic also checks whether a hospital has a Materiovigilance Committee capable of supporting decisions in unclear vigilance cases.
The committee may be responsible for:
assessing reporting obligations;
defining internal actions following incidents or FSNs;
contributing to the hospital’s materiovigilance strategy;
monitoring achievement of quality objectives. 1791440753927
Traceability and UDI
Traceability is another key inspection area.
Hospitals should ensure that all medical devices operated or supplied within the institution are recorded and traceable. 1791440753927
For Class III implantable medical devices, the checklist specifically assesses whether:
the UDI is recorded and stored;
UDI recording is performed electronically;
the device can be traced to the individual patient. 1791440753927 1791440753927
Hospitals should also provide implant cards and the additional required information to patients receiving implantable devices. 1791440753927
In-House Medical Devices and IVDs
The checklist also addresses in-house medical devices, including IVDs.
Devices manufactured and used exclusively within the healthcare institution should be recorded and notified to Swissmedic before being placed into service where required. 1791440753927
Reporting Serious Incidents
A major section of the checklist concerns the reporting of serious medical device incidents.
Healthcare professionals should be able to recognise potentially serious incidents and understand their obligation to report them internally to the Vigilance Contact Person. 1791440753927
The Vigilance Contact Person is responsible for reporting serious incidents to Swissmedic, while the healthcare institution should clearly define who reports incidents to the supplier. 1791440753927
Internal Reporting Process
Swissmedic expects the serious incident reporting process to be formally defined within the quality management system.
The internal procedure should address:
the definition of a serious incident;
reporting criteria;
how healthcare professionals report incidents internally;
responsibilities;
reporting deadlines;
management of the affected device;
reporting to Swissmedic and the supplier;
documentation. 1791440753927
The process should also cover point-of-care testing (POCT) and in-house medical devices, including IVDs. 1791440753927
Electronic Incident Reporting System
The checklist expects hospitals to use an internal reporting system for potentially serious incidents.
Swissmedic specifically checks whether this system is:
electronic;
independent from the hospital’s CIRS system. 1791440753927
Serious incidents should be entered into the internal system without delay. 1791440753927
Reporting Deadlines
The checklist explicitly refers to Swissmedic reporting timelines of:
2 days;
10 days;
15 days,
depending on the type and severity of the incident. 1791440753927
Where there is uncertainty as to whether an incident meets the reporting criteria, the checklist expects reporting to both Swissmedic and the supplier. 1791440753927
Management of FSNs and FSCAs
Another major inspection area concerns Field Safety Notices (FSNs) and Field Safety Corrective Actions (FSCAs).
Hospitals should have a defined process covering:
receipt;
analysis;
communication;
implementation;
final verification;
response to FSNs. 1791440753927
Responsibilities for each step and interfaces between departments should also be clearly defined. 1791440753927
Immediate Implementation of FSN Measures
Swissmedic expects all FSNs to be systematically recorded and analysed.
Affected departments, healthcare professionals and, where relevant, patients should be informed.
Measures communicated through an FSN should be implemented and documented without delay. 1791440753927
If implementation must exceptionally be delayed, the hospital should document:
the duration of the delay;
justification;
risk analysis;
responsible decision-makers.
The decision and justification should also be communicated to the FSN sender. 1791440753927
Hospitals Acting as Economic Operators
Where a healthcare institution assumes the role of an economic operator — such as manufacturer, importer, distributor or system/procedure pack producer — the institution must comply with the corresponding obligations under the MedDO or IvDO. 1791440753927
Materiovigilance Training
The final section of the checklist focuses on staff competence and training.
Hospitals should build and maintain staff knowledge through training on:
internal incident reporting;
FSN processes;
regulatory obligations;
recognition of serious incidents;
reporting deadlines;
documentation and archiving. 1791440753927
Internally organised materiovigilance training is expected to be mandatory. 1791440753927
Annual Refresher Training
The checklist also requires traceable records of training participation and an assessment of training effectiveness.
Staff knowledge of materiovigilance should be refreshed annually. 1791440753927
Impact on Swiss Hospitals and Medical Device Stakeholders
For hospitals and other healthcare institutions in Switzerland, the checklist provides a practical view of the areas Swissmedic may examine during a materiovigilance inspection.
Key priorities include:
documented governance and responsibilities;
an effective materiovigilance quality system;
trained Vigilance Contact Persons;
traceability and UDI controls;
clear serious incident reporting procedures;
compliance with reporting deadlines;
systematic FSN and FSCA handling;
integration with other vigilance systems;
adequate document retention;
mandatory and recurring staff training.
For manufacturers and suppliers, the checklist is also relevant because hospitals must maintain effective communication with economic operators during incident investigations and FSCA implementation.
