The objective of the European Medical Device Vigilance System
The overall objective of the European Medical Device Vigilance System is to improve the protection of health and safety of patients, users and others by minimising the potential for reoccurrence of the incident elsewhere. MDR 2017/745 Article 2 – defines an “incident” as any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect.Reporting criteria for an incident is based on the following elements :
- An event has occurred
- The Manufacturer’s device is suspected to be a contributory cause of the incident
- The event led, or might have led to one of the following outcomes
- Death of a patient, USER or other person
- Serious deterioration in state of health of a patient, USER or other person, lead to one of the following outcomes: death or serious deterioration in state of health of a patient, user or other person
Reporting timelines for reportable incidents in Europe are as follows:
Incident Type |
Reporting Timeline |
Serious public health threat |
IMMEDIATELY (without any delay that could be justified) but not later than 2 calendar days after awareness by the MANUFACTURER of this threat. |
Death or UNANTICIPATED serious deterioration in state of health |
IMMEDIATELY (without any delay that could not be justified) after the MANUFACTURER established a link between the device and the event but not later than 10 elapsed calendar days following the date of awareness of the event. |
Others |
IMMEDIATELY after they have established the causal relationship between that incident and their device or that such causal relationship is reasonably possible and not later than 15 days after they become aware of the incident. |