Serious incidents are any incidents that directly or indirectly led, might have led or might lead to
- 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 incidents must be reported no later than 15 days after the manufacturer becomes aware of the incident. In the event of death, the reporting time is 10 days. In the event of a serious public health threat, the reporting shall be carried out immediately.
An incident means, in respect of a device made available on the market,
- any malfunction or deterioration in its characteristics or performance;
- use-error due to its ergonomic features;
- any inadequacy in the information supplied by the manufacturer;
- undesirable side-effect.
- indicated in the instructions for use;
- the frequency is indicated in technical documentation.
Incidents and expected side effects shall be reported when the manufacturer identifies a statistically significant increase in the frequency or severity of an incident or expected side effect and, in addition, the adverse event could have a significant impact on the benefit-risk analysis. A significant increase in the frequency of an incident or expected side effect shall be specified in the technical file of the device.
For similar serious incidents that occur with the same device or device type, the manufacturer may provide periodic summary reports instead of individual serious incident reports. This is subject to the precondition that the root cause has been identified, a field safety corrective action has been implemented, or the incidents are common and well documented. Periodic summary reporting shall be agreed upon with the competent authority. In the agreement, the format, content and frequency of the reporting shall also be specified.
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. The manufacturer shall ensure that the field safety corrective actions taken are immediately communicated to the users of the device concerned by means of a field safety notice (FSN). If the case is not urgent, a draft of the field safety notice shall be submitted to the competent authority for prior inspection.
Trend report (available in 2021)
Periodic summary report (will be deployed in connection with the deployment of Eudamed)
The notice shall be sent by e-mail to email@example.com. The notice can also be sent by fax at +358 29 522 3002 or by post.
An incident report shall be submitted using the address:
Finnish Medicines Agency (Fimea)
PO Box 55
FI-00034 Helsinki, Finland
In urgent cases, the reporting may be made by telephone at +358 29 522 3341, but a written report shall also always be filed without delay.