| Regulations | Document Section |
|---|---|
| Medical Device Regulation Art. 87 and 89 | All |
| Medical Device Directive Art. 10 | All |
| ISO 13485:2016 Section 8.2.3 | All |
| MPDG, MPEUAnpV, MEDDEV 2.12/1 rev. 8 | All |
This template is used to assess whether an event with a potentially negative impact on the state of health constitutes a serious and reportable incident.
| General Information | |
|---|---|
| Description of Event: | <Describe e.g. the cause that led to the event, the relationship between device and event, urgency of required actions> |
| Report Date and Time: | |
| Affected Medical Device: | <Enter UDI here> |
| Incident Assessment: | The event is a reportable incident: ( ) Yes ( ) No |
| Action Planned: | <Describe FSCA> |
The following criteria are based on the MEDDEV 2.12/1 rev. 8 guidance document. Any event which meets all three criteria listed below is considered a serious incident and must be reported to the competent national authorities.
For correct understanding, keep in mind that the template form below can be also used to document appropriately why an event was NOT considered a reportable incident!
Criterion: An event has occurred that could be considered a serious and reportable incident.
| Applicable? | ( ) Yes ( ) No |
| Explanation: | <if no, describe why this is not applicable> |
| Category of event |
Examples of possible event categories are as follows. For more examples, see MEDDEV 2.12/1 rev. 8 guidance.
- Technical failure mode leading to unexpected behavior of a medical device
- Incorrect product claims (marketing material, instructions for use, labeling)
- New hazard-related use scenario occurred, i.e. usability problem
Note: The incident assessment must also consider information resulting from testing, reading the instructions for use or scientific data that indicate implications as outlined in step 3 below.
Criterion: A (direct or indirect) causal relationship is suspected between the device and the event.
| Applicable? | ( ) Yes ( ) No |
| Explanation: | <if no, describe why this is not applicable> |
Note: When assessing the relationship between the device and event the Person Responsible for Regulatory Compliance must take the following points into consideration:
From a risk management perspective, this decision should be made conservatively, i.e. if the situation is complex and/or potentially caused by multiple medical devices, the PRRC should have a tendency to assess this as “applicable” even if the matter still remains unclear.
Criterion: The event led, or might have led, to one of the following outcomes:
| Applicable? | ( ) Yes ( ) No |
| Explanation: | <if no, describe why this is not applicable> |
| Outcome: | ( ) death of a patient, user or other person ( ) serious deterioration in state of health of a patient, user or other person ( ) serious public health threat |
A serious deterioration in state of health results in at least one of the following:
Please note: Serious incidents may also include events where serious medical consequences have not occurred yet but could occur in the future under similar circumstances. If you are unsure, check the intended use of the device to assess whether the event should be excluded based on its (counter-)indications.
| Guidance Document | Explanation |
|---|---|
| Intended Purpose See MEDDEV 2.12/1, section 4.6 ‘Definitions’; See MDD Article 1.2 paragraph (g) |
The use for which the device is intended according to the data supplied by the manufacturer on the labeling, in the instructions for use and/or in promotional materials. |
| Incident See MEDDEV 2.12/1, section 4.6 ‘Definitions’ and annex I for examples |
Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health. |
| Direct or Indirect Harm See MEDDEV 2.12/1, section 4.6 ‘Definitions’ |
A physical injury or damage to the health of people, or damage to
property or the environment.In the majority of cases, diagnostic devices
will, due to their intended use, not directly lead to physical injury or
damage to health of people. These devices are more likely to lead to
indirect harm. Harm may then occur as a consequence of the medical
decision, action taken/not taken on the basis of information or
result(s) provided by the device or as a consequence of the treatment of
cells or organs outside of the human body that will later be transferred
to a patient. Examples of indirect harm include misdiagnosis, delayed diagnosis, delayed treatment, inappropriate treatment, absence of treatment transfusion of inappropriate materials. Indirect harm may be caused by imprecise results, inadequate quality controls, inadequate calibration, false positive or false negative results. |
| Field Safety Corrective Actions See MEDDEV 2.12/1, section 4.6 ‘Definitions’ |
FSCA is an action taken by a manufacturer to reduce a risk of death
or serious deterioration in the state of health associated with the use
of a medical device that is already placed on the market. Such actions,
whether associated with direct or indirect harm, should be reported and
should be notified via a field safety notice. FSCA may include: the return of a device to the supplier; device modification; device exchange; device destruction; advice given by manufacturer regarding the use of the device and/or the follow-up of patients, users or others (e.g. where the device is no longer on the market or has been withdrawn but could still possibly be in use). Manufacturers can as part of ongoing quality assurance identify a failure of a device to perform according to the characteristics specified in the information for use provided by the manufacturer. If the failure might lead to or might have led to death or serious deterioration in the state of health associated with the use of a medical device and has an impact on a product that has already been placed on the market the manufacturer must initiate a FSCA. Examples of failure modes may include software anomalies (e.g. incorrect correlation between patient sample and the obtained result, invalid controls or invalid calibrations). A device modification can include: - Permanent or temporary changes to the labeling or instructions for use (for example: advice for revised quality control procedures such as use of third party controls, more frequent calibration or modification of control values). - Software upgrades following the identification of a fault in the software version already in the market. This should be reported regardless of whether the software update is being implemented by customers, field service engineers or by remote access. Advice given by the manufacturer may include modifications to the clinical management of patients or samples to address a risk of death or a serious deterioration in state of health related to the characteristics of the device. For diagnostic devices, corrective action taking the form of the recall of patients or patient samples for retesting or the review of previous results constitutes FSCA. |
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