MDR Chapter 7 Vigilance Requirements – Reporting of Serious Incidents

MDR Chapter 7 Vigilance Requirements - Reporting of Serious Incidents

Nobody wants a medical device that they manufacture to harm a person or result in death. The important thing is to be able to take action immediately when faced with a serious adverse event and to report the situation to the compotent authorities as quickly as possible so that other people are not affected by this situation. In this article, we’ll try to explain to you “MDR Chapter 7 Vigilance Requirements and Reporting of Serious Incidents”.

Vigilance has always been a crucial part of medical device manufacturing.  This subject now gets all the attention on it with MDR. All you have to do is track well your devices on the market and follow the “serious incident” reporting periods.

For the full regulation please click here.

What is "Serious Incident"?

The definition of “serious incident” is exactly as follows in the MDR:

‘Serious Incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following;

  • the death of a patient, user or other person,
  • the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health,
  • a serious public health threat.


Serious Public Health Threat means an event which could result in imminent risk of death, serious deterioration in a person’s state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time.

Corrective Actions means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation.

Field Safety Corrective Action means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.

Field Safety Notice means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action.

When Should We Report the Incident ?

Serious adverse incidents within 15 days at the latest.

If there is a serious public health threat, immediately and at the latest 2 days.

In case of death or serious deterioration in health, within 10 days at the latest.

What are the points to pay attention to?

  • If the investigations require lot or device change, the Competent Authority shall be notified beforehand.
  • It should be kept in mind that usage errors arising from ergonomic features are included in the definition of adverse event.
  • If field safety corrective action has been initiated on a device sold to 3rd countries and same device is also on sale in EU member countries, the manufacturer reports this situation via EUDAMED.
  • Investigations of serious incidents should include a risk assessment.

When Compotent Authority inform you about MDR Chapter 7 Vigilance Requirements - Reporting of Serious Incidents

If a competent authority gets any serious incident information from healthcare professionals, users or patients, this authority shall inform you about it and take necessary actions. But, in your opinion, you consider that the incident is not a serious incident or is an expected undesirable side-effect, you should provide a explanatory statement. If the competent authority disagrees with you, they may request you to submit a report and to carry out the appropriate follow-up action.

Is there any template for the incident report?

European Comission has published a report template for indicents. You can download this template as imaged below by clicking here.

Manufacturer Incident Report (MIR)

Share This Post :


Related Posts