GP-004 Vigilance system

Procedure flowchart

Purpose

To establish the methodology to document, evaluate, investigate, and resolve incidents related to the use of our medical devices.

The procedure also describes the steps to be followed in case of notification to Regulatory Authorities (National Competent Authority and Notified Body) is required by regulations (chapter VII (Post-market surveillance, vigilance and Market surveillance) of MDR 2017/745, guidance MEDDEV 2.12-1, guidance MDCG 2023-3).

Scope

All the medical devices that we manufacture.

Definitions and relevant information

• The European Commission web portal dedicated to Market surveillance and vigilance is: https://ec.europa.eu/health/md_sector/market-surveillance-and-vigilance_en
• Abnormal use: Act or omission of an act by the operator or user of a medical device as a result of conduct beyond any means of risk control by the manufacturer.
• Corrective action: Action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation.
• Field safety corrective action (FSCA): Corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident about a device made available on the market.
• Field safety notice (FSN): A communication sent by a manufacturer to users or customers about a field safety corrective action.
• Harm: Physical injury or damage to the health of people, or damage to property or the environment.
• Immediately: For purposes of this procedure, immediately means without any delay that could not be justified.
• Incident: 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 and any undesirable side-effect.
• Serious incident: any incident that directly or indirectly led, might have led or might lead to any of the following:
  • 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;
• MIR: Manufacturer incidence report
• NCA: National Competent Authority
• NB: Notified Body
• Periodic summary report (PSR): An alternative reporting regime that is agreed upon between the manufacturer and the National Competent Authority for reporting similar incidents with the same device or device type in a consolidated way where the root cause is known or an FSCA has been implemented.
• Serious public health threat: An event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time.
• Trend reporting: A reporting type used by the manufacturer when a significant increase in events not normally considered to be incidents occurred and for which pre-defined trigger levels are used to determine the threshold for reporting.
• Unanticipated: A deterioration in state of health is considered unanticipated if the condition leading to the event was not considered in a risk analysis.
• Use error: Act or omission of an act, that has a different result to that intended by the manufacturer or expected by the operator of the medical device.
• User: Any health care professional or lay person who uses a device.

Responsibilities

JD-005

To detect and evaluate incidents or potential incidents coming from customer complaints, non-conformity or any other post-market surveillance activities. To make the pertinent communications to the competent authority and, if it is necessary, to withdraw the products from the market.

All team members

Notify the JD-005 about the existence of possible incidents for their correct analysis, control and pertinent communication to the competent authority, clients and users.

Inputs

Customer complaints and non-conformities related to AI LABS GROUP SL products.

Outputs

• Manufacturer incidence report (MIR)
• PSR
• FSCA
• FSN
• T-006-003 CAPA report
• T-004-001 Withdrawal record

Development

Receipt of notification of an incident

Potential incidents may be raised through a number or channels, ranging from telephone or email communications with customers to non-conformities detected internally.

Initially, all communications coming from customers are registered at the tickets management form according to GP-014 Feedback and complaints procedure.

When an employee becomes aware of an issue, they communicate the issue to the JD-004 and JD-005, who receive and evaluate the information, and decide first whether it corresponds to a customer complaint.

All communications that can lead to potential incidents will be investigated as explained in the next section.

Investigation and evaluation of incidents

We follow the process described in the flowchart. For further detail, the process can be described as follows:

1. We receive a customer complaint or we detect internally a non-conformity that may be classified as an incident. This information is immediately forwarded to JD-005 and JD-004 for their further evaluation. During the initial evaluation of the incident, the JD-005 must assess whether it is a potential incident or a confirmed incident. This evaluation is based on the criteria established in the following section of this procedure. At the same time, the necessary data about the event to establish a correct evaluation will be collected, registering all the relevant information in T-006-001 Non-conformity report or in the customer complaint in Hubspot. Internally, all the information and documentation that may be relevant to assess the scope and the risk of the event will be collected: serial numbers, location of the affected products, etc. If there is a well-founded suspicion that the event is a potential incident or a confirmed incident, the JD-005 will convene a meeting with the JD-001, JD-003 and JD-004.
2. If, after the evaluation of the event, the event is not considered as an incident, we will follow the process described in GP-006 Non-conformities, Corrective and preventive actions and in GP-014 Feedback and complaints to treat the event accordingly.
3. When it is confirmed that the event is an incident, JD-005 will perform a further evaluation of the incident to understand whether the incident is a serious incident and therefore it needs to be communicated to the Regulatory Authorities (National Competent Authority and Notified Body) according to the timelines defined further in this procedure. For this initial evaluation, we may need to get in contact with the user to access the device suspected to have contributed to the incident with the purpose of performing an investigation and test as soon as possible. If the manufacturer gains access to the device, and our initial assessment involves altering the device in a way that may affect the subsequent analysis, before proceeding, the manufacturer will inform the NCA through the Manufacturer Incident Report (MIR) using the format provided by the Guidance MEDDEV 2.12-1 rev.8 Vigilance system, Annex III: Report form from the manufacturer to the national competent authority.
4. Depending on the conclusions derived from the evaluation of the finding, it will proceed or not to notify the incident to the AEMPS and the NCA of the country where a finding is detected, and the corresponding Notified Body.
5. The JD-005 will notify the authorities, through the MIR, about the initial information collected. Each initial incident report will require a final report (including the final information collected and the actions related if they are finally needed). This report will be updated with any notice from the authorities and the investigation evolution. In the case of AEMPS it will be done electronically in https://sede.aemps.gob.es.
6. In case of an incident that is not deemed to be serious, we will address the incident by defining actions to be implemented to avoid the recurrence of the same issue according to the procedure GP-006 Non-conformities, Corrective and preventive actions and we will monitor the number of incidents and any trends according to the post-market activity of trend reporting described in GP-007 Post-market surveillance.

Criteria to notify an incident to the national competent authorities

The NCA will be notified when the incident is classified as a serious incident.

The criteria to be met in order to classify the incident as serious incident are the following:

• An event has occurred and it can be qualified as an incident.
• The product is suspected to have contributed to the cause of the incident.
• The event led or could lead to:
  • Patient, user or another person's death.
  • Serious deterioration of the health status of the patient, user or another person, such as:
    • Injury or illness with a threat to life.
    • Permanent deterioration of a bodily function or permanent damage of a body structure.
    • Process that requires medical or surgical intervention to avoid the permanent deterioration of a bodily function or the permanent damage of a body structure.
    • Fetal distress, fetal death or any congenital abnormality or birth defects.

Not all incidents end in death or a serious deterioration of the state of health. The fact that these do not occur may be due to other fortunate circumstances or the intervention of health personnel. As a general principle, in case of doubt about the notification of an incident, the incident will be notified.

Conditions where reporting under the medical device vigilance system is not usually required

Unless one of these scenarios leads to a serious incident as detailed above, notification of the following incidents will not be required:

• Defects discovered by the user before using a product.
• Events produced by the patient's conditions. In this case, data must be provided showing that the product has worked as planned and did not cause nor contribute to the death or serious deterioration of the patient's health status.
• Expiration of the useful lifetime or expiration of the medical device.
• Correct performance of the product against a fault.
• Foreseeable and expected side effects.
• Negligible probability of death or serious deterioration of the state of health. In case of occurrence, the incident will be notified, and a new risk assessment will have to be established.

Incidents which occurred outside the EEA, Switzerland and Turkey that do not lead to a Field Safety Corrective Action (FSCA) relevant to these geographic areas do not need to be reported. Incidents which occurred outside the EEA, Switzerland and Turkey that led to a FSCA relevant to the above-mentioned geographical areas must be reported as a FSCA.

Trend report

When a notable increase or trend is identified in those incidents that are generally excluded from the obligation to be notified according to the mentioned criteria in the previous section of this procedure, a notification must be sent to the AEMPS or other NCA in third member states, using the format for the Trend report provided by the Guidance MEDDEV 2.12-1 rev.8 Vigilance system, Annex VII: Manufacturer's trend report form.

In the case of the AEMPS it will be done electronically in the: https://sede.aemps.gob.es/PSCH/PS/vigilancia_ps.html

The report has been defined to actively control the trends of incidents related to our products according to the procedure GP-007 Post-market surveillance.

Notification to Regulatory Authorities

If it is considered that the incident meets the notification criteria, and therefore it is classified as a serious incident:

• The JD-005 will send an initial MIR to the AEMPS or other NCA in third member states for its registration and evaluation. Each initial report will lead to a final report, although if it is considered convenient they can be merged into one. Not all the incident reports will result in corrective actions. The initial report will be made according to the format shown on the MIR. In the case of the AEMPS it will be done electronically at: https://sede.aemps.gob.es/PSCH/PS/vigilancia_ps.html
• The results of the investigation and any action taken will be summarized in a final report detailing the actions undertaken, such as:
  • absence of measures,
  • additional control of the products in use,
  • preventive actions in future productions and field safety corrective actions.

This report will be sent to the AEMPS and to the corresponding NCA, waiting for a response and/or recommendations. The AEMPS and/or the NCA will disseminate the information they consider necessary to prevent future incidents, also communicating it to the Notified Body.

The format of the final report will be given by the MIR.

• The JD-005 is also in charge of notifying the Notified Body by means of the dedicated channel (BSI group submission and vigilance webpage).

Incidents occurred in Spain

The incidents that occurred in Spain will be managed through the telematic sending application of the Sistema de Vigilancia de Productos Sanitarios.

Alternatively, they will be sent by email (psvigilancia@aemps.es) following the timelines established in this procedure. If the investigation exceeds the period established in the initial report, a follow-up report must be submitted to the AEMPS.

Other contact details

• Agencia Española de Medicamentos y Productos Sanitarios
• Tel: +34918225274
• Fax: +34918225289
• Street: C/ Campezo 1, Edificio 8, 28022 Madrid
• Website: http://www.aemps.gob.es/

Incidents occurred in other member states

Depending on the country where the serious incident occurs, the applicable regulatory authority (NCA) should be searched: http://ec.europa.eu/growth/sectors/medical-devices/contacts_en.

Although the commercialization will take place in Spain, we are also responsible for the products commercialized abroad. If incidents are detected in third countries, we will notify the authorities of these countries to facilitate the investigation of possible incidents. The MIR will be sent to the NCA of the applicable country.

Timelines for initial communication of incidents

As soon as we become aware of an incident attributable to our products, we must contact the NCA in accordance with the following timelines:

• Serious incident: immediately after causal relationship is established/causal relationship is reasonably possible between the device and serious incident and no later than 15 calendar days.
• Serious threat to public health: immediately after we become aware of the threat and no later than 2 calendar days.
• Death or unanticipated serious deterioration in a person's state of health: immediately after established/suspected causal relationship between the device and serious incident and no later than 10 calendar days.

The Notified Body will also be notified following these timelines.

Investigation of serious incidents

In this step, the JD-005 will collect any useful information to investigate the root cause of the incident to define actions to address it.

The process described in GP-006 Non-conformities, Corrective and preventive actions will be followed to document the analysis and identification of necessary actions and, once the investigation and the required actions are implemented, the JD-005 will send the final report about the incident to the applicable NCA.

The JD-005 will also assess whether the incident introduces new risks or modifies existing risks and if the incident has any impacts on the clinical evaluation of the medical device.

One of the possible outputs of the incident's investigation is to implement a Field Safety Corrective Action (FSCA), as described in the section below.

Field Safety Corrective Action (FSCA)

A field safety corrective action (FSCA) is a corrective action taken 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.

The FSCA may require:

• the withdrawal of the product from the market (return of the medical device to the supplier).
• a device modification
• a device exchange
• a device destruction
• advice given by the 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
• changes of software/firmware in the device, including device updates.

A FSCA must be communicated/transmitted without undue delay for the attention of users or customers of the device in question through a field safety notice (FSN).

For the notification of a FSCA to the applicable NCA, we will use the template provided in the guidance MEDDEV 2.12-1 rev.8 Vigilance system, Annex IV: Report form for Field Safety Corrective Action.

Device traceability and customer list

When the decision to start a FSCA is taken, the JD-005 will identify all devices (and their versions) affected by the action and all the impacted customers/distributors in order to be able to notify them, without undue delay, by means of the field safety notice (FSN).

Field Safety Notice (FSN)

Before sending a FSN to the clients and users, a copy will be sent to the AEMPS and/or the NCA for its assessment. After approval, the JD-005 will inform the clients and the users of the corrective measures adopted by means of the FSN.

The communication will be made at the same time the FSCA is established. The FSN must be issued on paper or by electronic means, always with AI LABS GROUP SL letterhead, and must be written in Spanish and any other official language in third member states impacted by the field safety corrective action.

For its drafting, we will use the template provided in the guidance MEDDEV 2.12-1 rev.8 Vigilance system, Annex V: Template for a Field Safety Notice.

To proceed with FSCA, the following steps will be followed:

• Send the FSN to the affected users: FSN will be sent by email, registered letter or burofax depending on the alert situation.
• As it is a cloud software, in case of withdrawal of the product from the market, it is necessary to withdraw the software from the cloud, and users will no longer have access to the product.
• The JD-001 will decide if the product is paid or replaced, informing the JD-005, who will inform the AEMPS &/or NCA of the closure of the FSCA.
• Follow up with customers to have the confirmation that they received the notice and the actions stated in the FSN have been taken (in case any actions from users are required).
• The JD-005 will issue the report (MIR) in which all the actions related to the FSCA will be recorded, including a balance between the products recovered and delivered.

Withdrawal simulation

Every year a simulation of withdrawal from the market exercise will be carried out to verify the effectiveness of the instruction SP-004-001 Product withdrawal and will be documented in a dedicated report or through its integration in the T-004-001 Withdrawal record.

The JD-004 is responsible for determining the realization of this verification and it starts through the requesting of the traceability of a random device as it is described in the Procedure GP-016 Traceability and identification.

From the simulated notification of the UDI number &/or software license number, it is possible to find the location of the device. This verification is used to ensure that traceability is correct and the activities described in the vigilance system for notification of the incident are pertinent and correctly established to be carried out as fast as possible. This simulation will be notified to the affected people at least one day before by written media for its planning.

This process is recorded in the T-004-001 Withdrawal record and the conclusions are documented in the T-007-003 Periodic Safety Updated Report PSUR.

In the cases in which it is necessary to take action to improve the process described in this procedure, we will open a T-006-001 Non-conformity report as it is described in the procedure GP-006 Non-conformity. Corrective and preventive actions.

Interaction with other procedures

When an incident is received and classified as such, we will evaluate the risks associated with it:

• if it is a new risk, we will add it to the R-TF-013-002 Risk management record and evaluate it according to the process defined in the procedure GP-013 Risk management;
• if it is an existing risk, we will reevaluate the existing risks in terms of probability and severity scores, and mitigation measures.

We will also analyse whether the clinical evaluation of the affected medical device requires updates following the incident.

The procedures to be followed are:

• GP-007 Post-market surveillance
• GP-013 Risk management
• GP-015 Clinical evaluation

Associated documents

• GP-006 Non-conformity, Corrective and preventive actions
• GP-007 Post-market surveillance
• GP-014 Feedback and complaints
• GP-013 Risk management
• GP-015 Clinical evaluation
• GP-016 Traceability and identification
• SP-004-001 Product withdrawal
• T-004-001 Withdrawal record
• T-006-001 Non-conformity report
• T-006-003 CAPA record
• T-007-003 Periodic Safety Updated Report PSUR
• T-014-002 Complaints

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

• Author: Team members involved
• Reviewer: JD-003
• Approver: JD-004