Incident reporting procedure for devices in compliance with the Directive
For devices in compliance with the Directive, the incident reporting procedure previously in use shall be followed, i.e., all adverse events that meet the reporting criteria shall be reported on the MIR form. If the manufacturer has submitted an initial report on the event and, during the course of investigations, the manufacturer concludes that the event that came to its attention does not meet the criteria for an incident report, a final report on the event must also be submitted. In the MIR form, the event shall be classified according to section 1.2.d as “Final (Non-reportable incident)” and the rationale explaining why the event does not meet the criteria for an incident shall be filled out in section 4.2.b of the form.
Incidents are situations that have or might have led to a risk to the health of the patient, user, or other person and that result from the
- malfunction or deterioration in performance
- insufficient labelling
- insufficient or incorrect instructions for use of a medical device.
It is good to note that the situation caused by the device did not have to actually occur, it is enough that this could have happened.
Deadlines for submitting a report to the authorities
- Serious public health threat not later than 2 days after the manufacturer becomes aware of the threat.
- Death or an unanticipated serious deterioration in the state of health not later than 10 days after the date on which the manufacturer becomes aware of the incident
- Other events not later than 30 days of the date when the manufacturer becomes aware of the event.
Corrective actions shall be taken, and field safety notices issued, the same way as with devices in compliance with the Regulation.
Incident reporting procedure for devices in compliance with the Regulations (MDR/IVDR)
The difference between a serious incident and incident is the health hazard that a patient or another person incurred or could have incurred as a result of the incident. 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, any undesirable side effect, 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 (MD Regulation, Article 2, paragraphs 64 and 65).
An incident is classified as serious if it 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.
Deadlines for submitting a report to the authorities
- A serious public health threat shall be reported immediately. and in any event not later than within two days.
- In the event of death or an unanticipated serious deterioration in a person’s state of health, the reporting time is 10 days.
- Other serious incidents shall be reported not later than 15 days after the manufacturer becomes aware of the incident.
Side effects that are classified as incidents can be expected or unexpected. Known side effects, which are described in the product information of the device and quantified in its technical file, shall be reported as a trend report. Unexpected side effects that have not been taken into account in the risk analysis shall be reported either as a serious incident or as a trend report, depending on the consequence of the event.
The reporting shall be carried out using the MIR form.
Incidents and expected side effects (MD Regulation, Article 88) and expected erroneous results (IVD Regulation, Article 83) shall be reported as a trend report. Incidents and expected side effects/erroneous results shall be reported when the manufacturer identifies a statistically significant increase in the frequency or severity of an incident or expected side effect/erroneous results 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/erroneous results shall be specified in the technical file of the device.
The manufacturer shall specify in the post-market surveillance plan the methodology used for determining any statistically significant increase in the frequency or severity of incidents, as well as the period during which observation will be carried out.
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;
- any undesirable side-effect (medical devices);
- 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 (IVD devices).
Expected side effects and expected erroneous results
- Expected side effects shall be reported in the product information and their frequency in the technical documentation
- The number of expected erroneous results is commensurate with the analytical and clinical performance stated for the device in the product information and in the technical file (2017/746 Annex I, 9.1(a) and b(i))
Periodic summary report (PSR)
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 coordinating competent authority. After consulting the competent authorities, the coordinating authority agrees with the manufacturer on the form, content and frequency of presentation of the periodic summary reports.
The current Periodic Summary Report form shall be used for the reporting. When the Eudamed database is ready, the reporting will be carried out though the database and the required data contents shall be updated to comply with the Regulation.
Field safety corrective action
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.
Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD) (pdf), instructions for filling out the form: Helptext
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.