EU MDR Vigilance Reporting
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
Vigilance reporting is the EU MDR system requiring manufacturers to report serious incidents and field safety corrective actions involving their devices to the competent authorities of affected member states, and to submit periodic trend reports for statistically significant increases in the frequency or severity of otherwise non-reportable incidents, so authorities can detect emerging device risks across the EU market.
A serious incident — a malfunction or deterioration that led, or might have led, to death, serious deterioration in health, or a serious public health threat — must be reported through EUDAMED (or, until it is fully functional, national systems) within tight timelines: as short as two days for a serious public health threat, ten days for death or unanticipated serious deterioration, and fifteen days for other serious incidents.
Trend reporting captures the pattern MDR does not otherwise catch: incidents that are individually minor and non-reportable but whose frequency or severity is rising in a statistically or clinically significant way. A Field Safety Corrective Action — a recall, a field correction, or an advisory notice — must be accompanied by a Field Safety Notice to affected users and reported to the relevant authorities.
- —Covers serious incidents, trend reports, and Field Safety Corrective Actions
- —Reporting timelines run from 2 days (public health threat) to 15 days (other serious incidents)
- —Reports route through EUDAMED once fully operational, national systems in the interim
- —A FSCA requires a Field Safety Notice to affected users
EU MDR 2017/745 Articles 87–92; MDCG 2023-3 (vigilance reporting timelines guidance)
Frequently asked questions
What is EU MDR Vigilance Reporting?
Vigilance reporting is the EU MDR system requiring manufacturers to report serious incidents and field safety corrective actions involving their devices to the competent authorities of affected member states, and to submit periodic trend reports for statistically significant increases in the frequency or severity of otherwise non-reportable incidents, so authorities can detect emerging device risks across the EU market.
Which regulations cover EU MDR Vigilance Reporting?
EU MDR 2017/745 Articles 87–92; MDCG 2023-3 (vigilance reporting timelines guidance)