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SOP Vigilance

Use this SOP Vigilance template to guide the identification, investigation, documentation, and reporting of serious incidents and field safety corrective actions (FSCA) for medical devices, ensuring compliance with EU vigilance reporting requirements. Complete this document whenever a potential or confirmed serious incident, FSCA, or related safety concern arises, to fulfill mandatory timelines for notifying competent authorities and maintaining a robust quality management system. This SOP is essential for timely regulatory reporting, risk mitigation, and maintaining product safety in the post-market phase.
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SOP Vigilance

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1. Purpose

This document describes the processes for handling of serious safety events related to company products and corresponding field safety corrective action (FSCA). Also described are procedures for reporting requirements to competent authorities as needed.

2. Scope

User / field feedback and complaint handling is captured in SOP Feedback and Complaint Management, corrective and preventive actions (CAPAs) are captured in SOP Corrective and Preventive Action, and trend reporting is captured in SOP Post-Market Surveillance.

3. Definitions

When describing incidents, serious incidents, and related terms, reference is made to applicable regulations and internal processes. All definitions align with regulatory expectations and are documented in the quality management system.

4. Reporting

The following shall be reported to the relevant competent authorities in accordance with voluptas saepe .

  • Any serious incident involving devices made available on the Union market, except expected side-effects which are clearly documented in the product information and quantified in the technical documentation.
  • Any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country.

When considering if a complaint is related to an issue with the device, the following criteria should be considered relevant (MDCG 2023-3):

  • a malfunction or deterioration in its characteristic or performance;
  • an inadequacy in the information provided by the manufacturer; or
  • an undesirable side-effect.

4.1 Timeline for Reporting

In general, the period for reporting shall take into account the severity of the serious incident. Definitions for the events are provided in the definitions section (Section 2) above.

To ensure timely reporting, an initial report that is incomplete can be provided in lieu of a complete report which should be submitted when possible to complete the report. If there is uncertainty about whether an incident is reportable, a report shall still be submitted in accordance with the required time frames.

A flow chart for reporting from MDCG 2023-3 is provided for reference as Figure 1.

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Figure 1

The 'evaluating competent authority' is the national competent authority of the Member State responsible for the assessment of the risks arising from reported serious incident that occur within its territory, and/or of the adequacy of FSCAs envisaged or undertaken, within its territory, by the manufacturer (fugit quia). Most commonly, the evaluating competent authority corresponds to the following agencies for each type of event.

  • Serious incidents: the competent authority of the Member State in which the
    serious incident occurred.
  • FSCA(s): the competent authority(ies) of the Member State(s) in which the FSCA is being or is to be undertaken (e.g. Member States in which the devices affected by the FSCA are made available).
  • The competent authority in the Member State in which the manufacturer or its authorized representative has its registered place of business must always be informed of the FSCA, even if it is not amongst the Member States in which the FSCA is being or is to be undertaken.

4.2 Field Safety Corrective Action (FSCA)

A FSCA is a corrective action taken by a manufacturer for technical or medical reasons to either prevent or reduce the risk of a serious incident, which is associated with a device that is made available on the market. FSCAs are communicated/transmitted to users or customers of the device through a field safety notice (FSN).

A FSCA may include but are not necessarily limited to:

  • the return of a device to the supplier or a recall,
  • a device exchange,
  • a device modification,
  • retrofit by purchaser of manufacturer's modification or design change,
  • a device destruction,
  • advice given by manufacturer regarding the use of the device, such as additional information on maintenance, cleaning instructions, and training and/or the follow-up of patients, users or others,
  • recommended inspections/examination by device user (e.g. regular professional checks of proper functioning in a testing setting),
  • changes of software/firmware in the device, including device update (e.g. version
    rollback).

4.3 Field Safety Notice

The FSN is edited in an official Union language or languages determined by the Member State in which the field safety corrective action is taken. Except in cases of urgency, the content of the draft field safety notice shall be submitted to the evaluating competent authority to allow it to make comments. Unless duly justified by the situation of the individual Member State (e.g. a translation error in the instructions for use that appears only in certain languages and therefore affects only specific countries), the content of the FSN must be consistent in all Member States.

The FSN should contain the following information:

  • Relevant unique device identification (UDI) numbers
  • Single registration number (SRN) of the manufacturer that has undertaken the FSCA
  • Explanation of the reasons for the FSCA with reference to the device malfunction and associated risks to patients, users, or other relevant persons. It shall clearly indicate all the actions taken by the users.

FSNs shall be completed according to the process presented in this SOP using the Field Safety Notice Template.

4.4 Competent Authorities

As described above, incidents are reported to the national competent authority of the Member State responsible for the assessment of the risks arising from reported serious incident that occur within its territory, and/or of the adequacy of FSCAs envisaged or undertaken, within its territory.

A list of vigilance contact points is provided on the following website: Contacts - European Commission

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

5. Documentation Procedures

5.1 Vigilance Event Qualification

Input to the vigilance process may arrive through multiple input channels and is handled primarily through SOP Feedback and Complaint Management and SOP Post-Market Surveillance. Input channels are checked regularly according to the procedures in the place for each process for data acquisition, data analysis, and data reporting. Inputs can come from the following sources or others as needed.

  • Internal employees
  • Negative product events (See SOP Feedback and Complaint Management)
  • Device users, patients, or healthcare professionals (See SOP Feedback and Complaint Management)
  • Competent authorities
  • Economic operators
  • Routine monitoring procedures (See SOP Post-Market Surveillance)

Any employee of the company that obtains knowledge of an incident that could be potentially relevant to reporting according to this SOP shall notify the quality team who should, in turn, notify the Person Responsible for Regulatory Compliance (PRRC) immediately.

Events are considered relevant for vigilance if they may be a reportable event according to this SOP in section 3. If considered relevant, an investigation of the causal relationship of the event is determined in the next step (Section 4.2). Any corrective and preventive action shall be executed according to SOP Corrective and Preventive Action in response to the event.

If the quality team determines that the event may be reportable, an incident assessment form shall be created in order to document the final decision.

5.2 Investigation of Causal Relationship

After identifying the qualifying vigilance event, the quality team 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.

As mentioned above, when considering if a complaint is related to an issue with the device, the following criteria should be considered relevant (MDCG 2023-3):

  • a malfunction or deterioration in its characteristic or performance;
  • an inadequacy in the information provided by the manufacturer; or
  • an undesirable side-effect

An Incident Assessment form shall be completed in order to document the decision as to whether the incident was determined to be causal or not.

5.2.1 No Causal Relationship Determined

If it is determined that no causal relationship exists, the event is not considered a reportable serious incident. In such cases, the quality team proceeds with steps to assess if FSCA is still required (See Section 5.5).

For non-reportable incidents, an explanatory statement must be documented in the incident assessment form. Incidents that are not evaluated as reportable serious incidents must still be documented and considered in other quality management system processes.

5.2.2 Causal Relationship Determined

If it is determined that a casual relationship exists between the event and the device, the quality team evaluates if the event qualifies as a reportable serious incident by
filling out the incident assessment form. In the case of uncertainty, the event is always reported as a serious incident.

For reportable incidents, steps are taken to notify the required competent authorities within the applicable time frame as described in this SOP.

5.3 Reporting to Authorities

For reportable incidents, the quality team shall inform the PRRC of the incident who should inform the competent national authority about the event using required reporting forms respective to that competent authority. The PRRC compiles and provides a report with all information required. If applicable, a copy of the report is sent to the Notified Body involved in the conformity assessment procedure of the device.

Generally, the competent national authority must be informed:

  • Of any serious incidents with the organization's own medical devices
  • Of any field safety corrective action (FSCA) initiated by the organization (e.g. in response to serious incidents with comparable devices of other manufacturers)
  • Of any statistically significant increase in the frequency or severity of non-serious incidents or expected undesirable side-effects that could impact the benefit-risk-profile of the device (i.e., which have led or may lead to risks to the health or safety of patients, users or others that are unacceptable when weighed against the intended benefits. See quibusdam atque and SOP Post-Market Surveillance).

5.4 Initiate Field Safety Corrective Action

The quality team and PRRC shall determine the root cause of the incident and risks associated with it to determine if a FSCA is required. If it is determined that an FSCA is required, an FSN shall be drafted by the PRRC and quality team according to the FSN template. The FSCA is communicated without undue delay according to the requirements described above.

Customers should be informed of the FSN which shall contain at minimum the criteria described in Section 3.3.

A copy of the FSN shall be archived. Customers confirm the receipt of FSNs as well as the implementation of recommended actions. If any customers are unable to be reached or are blocked from communication for any reason, these details shall be captured as part of the CAPA as applicable.

All FSCA are documented as part of a CAPA according to SOP Corrective and Preventive Action and must be reported to competent national authorities. Handling of non-conforming products are governed by SOP Non-conforming Products

5.5 Verification and Evaluation of Effectiveness

The effectiveness of implemented FSCAs is evaluated as part of the CAPA. The closed CAPA will be documented according to SOP Corrective and Preventive Action and the FSN is provided to the competent authorities verify that all actions taken are deemed sufficient for any issues or events that initiated the FSCA.

All incident records are maintained within the QMS.

Mapping of Requirements

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