Glossary · EU medical devices: MDR
Vigilance (MDR and IVDR)
Also known as: Medical device vigilance, Serious incident reporting, Field safety corrective action (FSCA), Field safety notice (FSN)
Under the EU Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, vigilance is the system for reporting and analyzing serious incidents and field safety corrective actions concerning devices made available on the EU market. Manufacturers report serious incidents to the competent authorities within fixed deadlines, investigate them and inform users of corrective actions through field safety notices.
- EU
- MDR
- IVDR
In one sentence
Vigilance under MDR Art. 87 and IVDR Art. 82: reporting serious incidents and field safety corrective actions to authorities within 2, 10 or 15 days.
Example
A manufacturer learns that a glucose meter showed falsely low readings, which led to a hospital admission. It reports the serious incident within 15 days, starts a field safety corrective action and sends a field safety notice to users.
How it applies
- Deadlines: A serious incident is reported immediately after the manufacturer has established a causal relationship or its reasonable possibility, and not later than 15 days after awareness. A serious public health threat: not later than 2 days. Death or an unanticipated serious deterioration in health: not later than 10 days.
- Field safety corrective actions: Recalls, modifications, software updates or changed instructions taken for safety reasons are reported before they are carried out, except in urgent cases, and communicated to users through a field safety notice.
- Trend reporting: Statistically significant increases in non-serious incidents or expected side effects are reported under Article 88 MDR.
- Reporting route: Reports go to the competent authority of the member state where the incident occurred, in future through the vigilance module of EUDAMED; check which modules are mandatory and use the national routes until then. MDCG 2023-3 explains the vigilance terms.
- Other operators: Importers, distributors and health professionals pass on complaints and suspected incidents; see economic operators.
- Technical documentation: Incident investigations update the risk file and are summarized in the PSUR or PMS report. Field safety notices are controlled documents with their own version history.
Incident vs. serious incident
An incident is any malfunction or deterioration in the characteristics or performance of a device, any inadequacy in the information supplied by the manufacturer, or an undesirable side effect. A serious incident is one that directly or indirectly led, might have led or might lead to death, a serious deterioration in health or a serious public health threat. Only serious incidents trigger the individual reporting deadlines; other incidents count toward trends.
Compared with the USA
FDA Medical Device Reporting (21 CFR Part 803) requires manufacturers to report deaths, serious injuries and certain malfunctions within 30 calendar days, and within 5 work days where remedial action is needed to prevent an unreasonable risk of substantial harm. Corrections and removals are reported separately.