Materiovigilance: reporting medical device incidents
Materiovigilance governs reporting on medical devices. The legal basis is Art. 66 MedDO, which adopts the deadlines of Art. 87 EU MDR: two days for a serious public health threat, ten days for a death or serious deterioration in health, fifteen days for other serious incidents.
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What is a serious incident?
An incident is a malfunction, a deterioration in the characteristics or performance of a device, a use error caused by ergonomic features, or inadequate information supplied by the manufacturer. It is serious if it led or might lead, directly or indirectly, to death, to a serious deterioration in health or to a serious public health threat.
Who reports what?
Materiovigilance has two reporting paths. Professional users and operators report incidents to the manufacturer or its Swiss authorised representative and to Swissmedic. Manufacturers, representatives, importers and distributors report as economic operators, on the short deadlines and with a duty to capture trends and corrective actions.
| Who | What | Deadline | Where |
|---|---|---|---|
| Professional, hospital, operator | Serious incident | Without delay | Manufacturer or CH-REP and Swissmedic |
| Manufacturer, CH-REP | Serious public health threat | 2 days | Swissmedic |
| Manufacturer, CH-REP | Death or serious deterioration in health | 10 days | Swissmedic |
| Manufacturer, CH-REP | Other serious incidents | 15 days | Swissmedic |
| Manufacturer, CH-REP | Field safety corrective action (FSCA) | Before implementation | Swissmedic |
| Patient | Incident | No deadline | Point of supply, or Swissmedic |
Two days means calendar days
The two day deadline for a serious public health threat runs over the weekend. Without on-call cover, a Friday case loses the deadline. Put the triage decision and the reachability of the responsible person in writing.
FSCA and field safety notice
A field safety corrective action, FSCA, is any action a manufacturer takes for technical or medical reasons to reduce the risk of a device already placed on the market: recall, exchange, retrofit, software update or changed instructions for use. The accompanying customer letter is the field safety notice.
- Assess the risk and define the action, with a rationale and the affected serial or batch numbers.
- File the FSCA notification with Swissmedic, as a rule before implementing it in the market.
- Draft the field safety notice, in the necessary national languages and pitched at its audience.
- Implement the action and track the responses from users.
- Verify effectiveness and close the action on the record.
The role of the Swiss authorised representative
A manufacturer without a Swiss establishment needs a Swiss authorised representative, the CH-REP. The CH-REP is the Swissmedic contact point, keeps the technical documentation available and is built into vigilance. In practice materiovigilance often fails at the interface between manufacturer and CH-REP: without a contractual reporting chain and access to the incident data the CH-REP cannot fulfil the role.
An incident in hospital: what to do immediately
The first minutes decide whether the case stays explainable. Secure the device in the state it was in: do not clean, repair, reprocess or discard it. Document settings, alarms, consumables and ambient conditions, and record the serial or batch number.
- Quarantine the device, unchanged and labelled
- Record the serial or batch number, the UDI and the software version
- Photograph the settings, alarms and error messages
- Retain the consumables and accessories involved
- Inform your internal materiovigilance contact person
- Trigger the report to the manufacturer or CH-REP and to Swissmedic
Drawing the line against medicinal pharmacovigilance
With combination products the allocation is not always obvious. A prefilled pen containing an active substance is a medicinal product; an injection device without one is a medical device. If the pen fails mechanically and the patient therefore receives no dose, both systems are involved: report the lack of effect as a medicinal case and the technical failure as an incident, and cross-reference each in the other.
Frequently asked questions
Where is Swiss materiovigilance regulated?
In the Medical Devices Ordinance MedDO (SR 812.213), in particular Art. 66, which refers to Art. 87 of EU Regulation 2017/745 for the reporting deadlines. For in vitro diagnostics the IvDO applies, referring to Art. 82 of EU Regulation 2017/746.
Do users have to report every incident?
The duty covers serious incidents. Minor malfunctions without a health risk go to the manufacturer as a complaint, which then has to evaluate them in its trend analysis. When in doubt, report: triage is the manufacturer's and Swissmedic's job.
What is a trend report?
A trend report captures a statistically significant increase in non-serious incidents or expected side effects that would not be individually reportable. The manufacturer has to set thresholds for it and document the evaluation.
Does a foreign manufacturer need a Swiss vigilance contact person?
The Swiss authorised representative is the regulatory contact point and has to be built into the vigilance processes. Hospitals and operators additionally name an internal materiovigilance contact person who collects and forwards reports.
May we keep using the device after an incident?
The item involved has to be quarantined and taken out of use until the manufacturer has examined it. Whether identical devices may continue in use depends on the risk assessment and on any FSCA.
Do you need an RPPV in Switzerland?
We act as the qualified person responsible for pharmacovigilance, run case processing and write the PSURs for your Swiss authorisations.