All medical device manufacturers are required to have an effective system for the review and evaluation of customer complaints. The European Commission guidance MEDDEV 2.12/1 revision 8, describes the steps involved in the notification and evaluation of Incidents and field Safety Corrective Actions (FSCA’s) concerning medical devices collectively referred to as the Medical Device Vigilance System. This article details an important guide for you to navigate through the European Medical Device Vigilance System.
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 are 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 the state of health of a patient, USER or other person, leads to one of the following outcomes: death or serious deterioration in the state of health of a patient, user or other person
Once a manufacturer becomes aware of the fact that an event has occurred and that event involved one of its medical devices, the medical device manufacturer must determine whether the event constitutes an incident.
*Note – In cases where doubt exists about whether an event constitutes a reportable incident or not, there should be a pre-disposition to report rather than not report.
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 |
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. |
The manufacturer or authorised representative is responsible for submitting the initial incident report (DocsRoom – European Commission (europa.eu) and subsequent follow-up, or final reports. A final report will be required in each case except where the initial and final report are combined into one report. Reports at a minimum should be submitted to the national competent authority in the country of occurrence of the incident and the associated Notified Body where applicable.
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