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Updated January 28, 2022

Template: SOP Vigilance

Sven Piechottka
ISO 13485

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SOP Vigilance

ISO 13485:2016 Section Document Section
8.2.3 All
Medical Device Regulation Document Section
Art. 87 All

Regulatory references: check MEDDEV 2.12./1 for guidance on this topic. As a German manufacturer, you are also subject to national law which lays out more specific requirements (note that in preparation for MDR, the Medizinproduktegesetz (MPG) was replaced by the Medizinprodukte-Durchführungsgesetz (MPDG) and the Medizinprodukte-EU-Anpassungsverordnung (MPEUAnpV) replaced the old Medizinprodukte-Sicherheitsplanverordnung (MPSV)).


This SOP describes how we handle (potential) incidents. Specifically, it outlines how we follow the requirements for the reporting of and necessary immediate action for adverse events.

General Considerations

Reportable Incident

Any incident that our organization becomes aware of is reportable, if one of our medical devices could be its cause and if it fulfills the definition of an incident as outlined in this process. Potential incidents are assessed based on our respective template form for incident assessment [reference document ID here].

A medical device incident is defined as “any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, user or other person or to a serious deterioration in their state of health” (see MEDDEV 2.12./1). Examples are (non-exclusively):

A serious deterioration in state of health includes at least one of the following:

Note that: not all incidents lead to death or serious deterioration in health. The non-occurrence of such a result might have been due to fortunate circumstances or to the intervention of healthcare personnel. It is sufficient that: (a) an incident associated with a device happened, and (b) the incident was such that, if it occurred again, it might lead to death or serious deterioration in health.

Field Safety Corrective Action (FSCA)

A field safety corrective action (FSCA) is an action taken to reduce a risk of death or serious deterioration in the state of health associated with a device that is already placed on the market. Such actions, whether related to direct or indirect harm, should be reported and informed about via a field safety notice. FSCAs can include (non-exclusively):

Reporting Timescale

All report times refer to when the national responsible authority must first be notified. In case of uncertainty whether the incident has to be reported or not, it is reported within the above deadlines.

Responsible Authorities

Incidents are reported to the authority of the country in which the reportable incident occurred:





Other national authorities:

More contact data can be found under this link on the website of the European Commission.

FSCA is reported to the authorities in the countries in which the FSCA is carried out, including incidents which occurred outside of the European Economic Area (EEA) but resulted in a recall within European countries.

In parallel to reporting incidents to responsible authorities, our Notified Body is informed where applicable in respect to the applied conformity assessment procedure.

Process Steps

1. Documentation, Investigation and Evaluation of Incidents

Any employee of the company that obtains knowledge of an event with a potentially negative impact on the state of health shall immediately notify the Person Responsible for Regulatory Compliance (PRRC) to initiate this process.

In a first step, the PRRC investigates the root causes of the event to determine if there is a causal relationship between the use of the medical device and the event. The investigation is documented as a CAPA. If there is no causal relationship, the event is not considered a reportable incident.

If there is a relationship, the PRRC secondly evaluates if the event qualifies as a reportable incident by filling out our template form for incident assessment [reference document ID here].

In the case of uncertainty, the event is reported as a reportable incident.

Person Responsible for Regulatory Compliance (MDSO / PRRC)
Input Output
Event with a potentially negative impact on the state of health Completed investigation and evaluation of the event

2. Reporting of Incidents

Within the applicable reporting timescale (see general considerations above), the PRRC informs the responsible national authority about the event using respective reporting forms. S/he compiles and provides a report with all information required and available at the time.

If applicable, a copy of the report is sent to the Notified Body involved in the conformity assessment procedure of the device.

Person Responsible for Regulatory Compliance (MDSO / PRRC)
Input Output
Completed investigation and evaluation of the incident Completed reporting to authorities (and Notified Body)

3. Decision on Immediate Action (FSCA)

Based on a risk and root cause analysis of the event, the PRRC decides if FSCAs are required to reduce existing risks. Before actions are taken, we inform users / customers about such as part of a field safety notice (FSN).

The FSN is written in the language of the respective country and must at minimum include:

All FSCA is documented as part of the CAPA. A copy of the FSN shall be archived. Customers confirm the receipt of FSNs as well as the implementation of recommended actions. If a customer does not respond, at least three attempts for delivery should be made. It is also documented as part of the CAPA if all attempts to inform a customer were unsuccessful.

You may want to consider a separate process regarding the handling of non-conforming products. This process would entail labeling instructions for respective product code and instructions for employees handling those products.

Person Responsible for Regulatory Compliance (MDSO / PRRC)
Input Output
Risks resulting from incident Implemented FSCA, including FSN

4. Verification and Evaluation of Effectiveness

The effectiveness of implemented FSCA is evaluated as part of the CAPA. As soon as the CAPA is closed, a final report is sent to the responsible authorities to verify that all actions taken are deemed sufficient for completion.

All incident records shall be archived as part of the QMS.

Person Responsible for Regulatory Compliance (MDSO / PRRC)
Input Output
Implementation of FSCA Final incident report and closed CAPA

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