Vigilance Data Collection and Monitoring

Key Requirements

• Reporting of Serious Incidents and Field Safety Corrective Actions: Under Article 87 of the EU MDR and the clarifications provided in MDCG 2023-3 Rev. 2, Manufacturers must report qualifying serious incidents involving devices made available on the EU market and field safety corrective actions undertaken in the EU or, under the applicable conditions, in third countries. Serious incident reporting includes incidents that have led, might have led, or might lead to death, serious deterioration in a person's state of health, or a serious public health threat, as defined under the EU MDR. Expected undesirable side-effects that meet the specific conditions of Article 87(1)(a) are subject to trend reporting rather than individual serious incident reporting. Field safety corrective action (FSCA) refers to a corrective action taken by a manufacturer for technical or clinical reasons to prevent or reduce the risk of a serious incident associated with a device made available on the market. Examples may include device recall, modification, exchange, software updates, or specific user recommendations, depending on the circumstances. Manufacturers must submit vigilance reports through the applicable electronic reporting system in accordance with the MDR and applicable reporting arrangements. The reporting deadlines based on the severity and nature of the event:

Serious Incident Reporting Timelines

Where necessary, manufacturers may submit an initial report with incomplete information and provide a follow-up report containing the additional findings. If the manufacturer is uncertain whether an incident is reportable, Article 87(7) requires reporting within the timeframe.

• Trend Reporting: Under Article 88, Trend reporting enables manufacturers to identify statistically significant increases in the frequency or severity of incidents that are not serious incidents, including expected undesirable side-effects, where these could significantly affect the benefit–risk analysis and result in unacceptable risks to patients, users, or other persons. Manufacturers must establish and document the methodology used to identify such increases, including the observation period, statistical approach, and criteria for assessing changes in incident frequency or severity. These arrangements must be addressed in the post-market surveillance plan. Trend reporting supports the early detection of emerging safety signals and enables manufacturers to initiate appropriate risk assessment, investigation, and corrective or preventive measures when warranted.
• Investigation of Serious Incidents and Field Safety Corrective Actions: In accordance with Article 89, Following the reporting of a serious incident, manufacturers must promptly investigate the event and the device concerned. The investigation should be proportionate to the nature and severity of the incident and include an assessment of the associated risks and the need for corrective action. The investigation typically involves:
• Collecting and reviewing available incident information and device history.
• Evaluating the potential causal relationship between the device and the incident.
• Investigating the root cause, where possible.
• Assessing the severity, probability, detectability, and potential consequences of the identified failure or hazard.
• Determining whether an FSCA or other corrective action is necessary.
• Evaluating the effectiveness of the measures implemented.
• Documenting the investigation, conclusions, and corrective actions in the final report.

Manufacturers must cooperate with the relevant competent authorities and the notified body. They must not alter the device or an affected batch sample in a way that could compromise subsequent investigation without first informing the competent authorities, as required by Article 89(1).

The manufacturer shall prepare the Field Safety Corrective Action (FSCA) documentation (FSCA Form), including details of the affected devices, the reason for the corrective action, associated risks, and measures implemented to eliminate or reduce those risks. The manufacturer shall communicate the action to affected users through a Field Safety Notice (FSN) without undue delay, clearly identifying the affected devices, explaining the reason for the action and associated risks, and specifying the actions required of users. The FSN content should remain consistent across Member States unless duly justified by specific circumstances. Except in urgent circumstances, the manufacturer shall submit the draft FSN to the evaluating Competent Authority for review and comments before finalisation, allowing 48 hours (two weekdays) for comments unless a shorter period is required by the circumstances. The final FSN and related documentation shall be transmitted to the relevant Competent Authorities in accordance with Article 89 of Regulation (EU) 2017/745 and the applicable vigilance procedures.

• Analysis of Vigilance Data: Article 90 provides for the monitoring of vigilance data to identify trends, patterns, and safety signals that may indicate new risks or changes in the frequency of known risks. The analysis supports the identification of previously unrecognised hazards, changes in the occurrence or severity of known adverse events, and circumstances that could affect the device's benefit–risk determination. Where new risks are identified or an anticipated risk changes significantly and adversely affects the benefit–risk determination, the manufacturer or authorised representative, as applicable, must take the necessary corrective actions. Vigilance findings should also inform the manufacturer's risk management process, PMS activities, clinical evaluation, and relevant technical documentation.
• Electronic System for Vigilance and Post-Market Surveillance: Article 92 establishes the electronic system for the collection and processing of vigilance and post-market surveillance information. The system supports the exchange of information between manufacturers, competent authorities, the European Commission, and notified bodies, as applicable. The information covered includes:
• Serious incident reports and final investigation reports.
• Field safety corrective action reports.
• Periodic summary reports, where permitted.
• Trend reports.
• Periodic Safety Update Reports (PSURs).
• Field Safety Notices.
• Relevant information exchanged between competent authorities.

Applicable reporting channels and electronic systems must be used in accordance with the MDR and the relevant implementation arrangements. The availability and use of specific electronic reporting functions should be verified against the current regulatory implementation status.

How Does Vigilance Support the Quality Management System?

Vigilance is closely linked to the manufacturer's PMS system, risk management process, clinical evaluation, and corrective and preventive action (CAPA) system.

Information obtained from serious incident investigations, trend reports, customer complaints, and FSCAs should be evaluated to determine whether changes are required to:

• The device risk management file and benefit–risk assessment.
• Clinical evaluation and PMCF activities.
• Product design, manufacturing processes, or inspection controls.
• Labelling, instructions for use, warnings, and precautions.
• PMS plans, procedures, and reporting criteria.
• Corrective and preventive actions and their effectiveness checks.

This integration ensures that post-market safety information is systematically evaluated and translated into appropriate regulatory, clinical, and quality-related actions.

MEDREG support medical device and IVD manufacturers in establishing and maintaining vigilance systems in accordance with EU MDR 2017/745 and IVDR 2017/746 to ensure timely incident reporting, effective risk management, and continued patient safety.