Medical Devices

Adverse incidents

Incident reports

Regulation (EU) 2017/745 and (EU) 2017/746 define:

Incident means 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 harm as a consequence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device;

Serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat.

An adverse incident that is required to be reported to the Agency for Medicinal Products and Medical Devices must meet the following criteria for reporting:

1. Occurrence of an incident

• A device that fails or is losing its ability to achieve its intended purpose,
• A deterioration in the characteristics of the device that is related to manufacturing errors,
• A use error due to the ergonomic features of the device,
• Any inadequacy in the information supplied by the manufacturer,
• Unclear instructions in the labelling or the manufacturer’s instructions for use,
• Incorrect labelling,
• Undesirable side-effects,
• Harm to a person resulting from a medical decision, action taken, or not taken, based on incorrect information or result(s) provided by the device.

2. The incident directly or indirectly led, might have led, or might lead to any of the outcomes of a serious incident

• 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.**

* A serious deterioration in the state of health of a patient, user or other person can include:

1. a life-threatening illness or injury,
2. temporary or permanent impairment of a body structure or a body function,
3. a condition necessitating hospitalisation or prolongation of existing hospitalisation,
4. medical or surgical intervention to prevent I or II, examples of this can be:
   1. professional medical care or additional unplanned medical treatment,
   2. a clinically relevant increase in the duration of a surgical procedure.
5. a chronic disease,
6. foetal distress, foetal death or any congenital abnormality (including congenital physical or mental impairment) or birth defects.

** A serious public health threat as defined in Article 2(66) MDR/Article 2(69) IVDR should in the context of this document be understood as events that would include:

1. the possibility of multiple deaths occurring at short intervals,
2. events that are of significant and unexpected nature, such that they become alarming as a potential public health hazard.

3. Causal relationship between the serious incident and the manufacturer's device has been established, is reasonably possible or suspected

In assessing the potential link between their device and the serious incident, the manufacturer should take account of factors such as:

• clinical or medical plausibility,
• the opinion of healthcare professionals,
• the results of the manufacturer’s own preliminary assessment,
• known information provided in the technical documentation and evidence of previous similar serious incidents,
• other relevant evidence held by the manufacturer.

The reporting timelines for the manufacturers are the following:

• any serious incident that did not involve a death or an unanticipated serious deterioration in a person's state of health must be reported immediately, and no later than 15 days after the awareness date of the serious incident,
• a serious public health threat must be reported immediately, and not later than 2 days after the manufacturer becomes aware of that threat,
• death or an unanticipated serious deterioration in a person's state of health must be reported immediately and no later than 10 days after the awareness date of the serious incident.

The forms for reporting an adverse incident can be found here.