Vigilance System

A medical device Vigilance System is the observation of serious incidents or adverse events related to medical devices which is a part of Post-market surveillance and reporting such incidents to competent authorities prevents them from recurring.

Information about vigilance is mentioned in articles 87 to 92 of EU-MDR and articles 82 to 87 of IVDR. MEDDEV 2.12-1, Rev. 8 on Guidelines a Medical Devices Vigilance System is also applicable for vigilance systems.

Vigilance reporting for In-vitro diagnostic medical devices (IVD’s) may be more difficult as compared to other devices because IVD’s do not come in contact with the patient. Therefore, it may be difficult to identify the direct harm to the patient. Whether the result of harm is direct or indirect, incidence should be reported.

In the case of potential errors by USERs or third parties, labeling and instructions for use should be carefully reviewed for any possible deficiency. This is mostly true for devices used for self-testing where a medical decision is usually made by the patient. Deficiency or error in the information supplied by the manufacturer that led or could have led to HARM to users, patients, or third parties should be reported.

A manufacturer or its authorized representative must submit an initial incidence report to the Competent Authority for recording and evaluation. Each initial report must be a final report or combination of both initial and final reports in one report, not every incidence required corrective action if any incidence might lead cause of death or it may cause serious problem inpatient or user that led to the withdraw of the medical device into the market by manufacture due to safety concern.

Incident reporting and Field Safety Corrective Action (FSCA)

An Incident Report will be received to the manufacturer through a layperson, a distributor, authorized representative or healthcare professional, or Competent Authority itself. Upon receiving an incident report, the manufacturer must send an initial report to the Competent Authority and the manufacturer has the responsibility to investigate related to the incident reported.

Manufacturers of devices made available on the European market, other than investigational devices, shall report the following aspects to the relevant competent authorities

• any serious incidents related to medical devices that are available on the Union market, except side-effects which are documented in the product information and quantified in the technical documentation and are subject to trend reporting
• any serious incidents related to medical devices that are available on the Union market, except side-effects which are documented in the product information and quantified in the technical documentation and are subject to trend reportings
• Manufacturers shall report any serious incident immediately after they have established the causal relationship between that incident and their medical device or such causal relationship is reasonably possible and not later than 15 days after they become aware of the incident.
• If the event is a serious public health threat manufacturer should provide the corrective action not later than 2 days after the manufacturer becomes aware of the threat.
• If the event of death or an unanticipated serious deterioration in a person’s state of health the report shall be provided immediately after the manufacturer has established or as soon as it suspects a causal relationship between the device and the serious incident but not later than 10 days after the date on which the manufacturer becomes aware of the serious incident.
• For similar serious incidence which has occurred for the same device or device type and for which the root cause has been identified or a field safety corrective action implemented or where the incidents are common and well documented, the manufacturer may provide periodic summary reports instead of individual serious incident reports.
• The report shall be submitted to the Competent Authority through the electronic system.

Field Safety Corrective Action (FSCA)

A Field Safety Corrective Action (FSCA) is an action taken by a manufacturer to reduce a risk related to death or serious collapse concerning health which is associated with the use of a medical device that is already placed on the market. Such actions should be notified via a Field Safety Notice.

The Field Safety Corrective Action (FSCA) may include:

• The return of the medical device to the supplier
• Details of device modification
• Device exchange
• Device destruction

Trend Reporting

Article 88 of EU-MDR and 83 of IVDR have mentioned the requirements of trend reporting, but both articles mentioned different requirements for medical devices and In-vitro diagnostic devices.

A trend reporting is used by the manufacturer when a significant increase in events that are not normally considered to be incidents or that are expected undesirable side- effects that could have a significant impact on the benefit-risk analysis or which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits.

The competent authorities may assess the trend report and require the manufacturer to adopt appropriate measures per this Regulation to ensure the protection of public health and patient safety.

What needs to be reported in Trend reporting?

Manufacturers shall report any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side effects that could have a significant impact on the benefit-risk analysis and which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits using the electronic system.

Electronic system on Medical device Vigilance

Eudamed’s electronic system on Medical device vigilance should enable manufacturers to report serious incidents and other reportable events. It allows them to support the coordination of the evaluation of such incidents and events by competent authorities. The electronic system for market surveillance should be a tool for the exchange of information between competent authorities.

How does Maven help to prepare a Medical device vigilance system?

Maven experts are aware and have expertise in the medical device vigilance system as per MEDDEV 2.12-1 rev, Regulation (EU) 2017/745 & 2017/746, EN ISO 13485:2016. We can help in documentation of the system as a part of technical documentation and make you engage with the information need to collect from the market related to a medical device. Implementing the Medical device vigilance system and exchange of information through an Electronic database called EUDAMED is necessary to ensure public safety.

FAQ: