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MEDDEV 2.12-1 rev 6

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Medical Device Vigilance System

Vigilance means to be watchful of the possible danger or difficulties. The Medical Device Vigilance System is designed to collect information on post-market incidents or adverse events related to medical devices and, where appropriate, to distribute or disseminate such information to prevent adverse events from recurring.

 

It is intended to ease a direct, early, and harmonized implementation of Field Safety Corrective Actions (FSCA) across the European member states where the device is in use.

Medical Device Vigilance System

Importance of Medical Device Vigilance Reporting

Vigilance is discussed as one of the main topics in Chapter VII of the EU MDR and IVDR, articles 87 – 92 and 82-87 respectively comprise of the Vigilance system. The guidance applicable for the same is Meddev 2.12-1, Rev 8. It is also a requirement under EN ISO 13485, Clause 8.2.3 (Reporting to Regulatory Authority).

 

This indicates that medical device manufacturers must have a dedicated system in place for the management of vigilance activities.

 

It is the manufacturer’s or the EAR’s obligation that they should notify the Competent Authority in case of any deterioration in the characteristics and performance of the medical device or any inadequacy in the instructions for use which might lead to or which has caused the death or the serious deterioration of the state of health of a patient or user as well the safety reasons that led to the withdrawal of the medical device from the market by the manufacturer.

Incident Reporting System

An Incident Report will be received to the manufacturer through a layperson, a distributer or healthcare professional or from the Competent Authority itself. Upon receiving an incident report, the manufacturer must first send an initial report to the Competent Authority after which the manufacturer has an obligation to investigate, in relation to the incident reported.

 

 

The investigation may lead the manufacturer to undertake a risk assessment and conduct Field Safety Corrective Action (FSCA) via a Field Safety Notice (FSN) to the users without any delay. After which a Final Report is sent to the Competent Authority with the description of the corrective actions taken in addition to safety alert to the users. In the event, if the manufacturer has not taken any action against the incident report, they must provide a justification in the Final Report submitted to the Competent Authority.

All the reporting should take place electronically.

 

A MedDev Medical Device Vigilance System Report should be submitted to the relevant authorities under these criteria:

  • An event has occurred;
  • The device is considered to be a contributory cause of any incident;
  • The event led or might have led to the death of a patient, user, or another person or serious injury or deterioration of the health of the patient, the user, or another person.

Trend Reporting

US FDA Approval

Trend Reporting is the manufacturer’s reporting through an electronic system when there is a statistically significant increase in the frequency or severity of incidents that are non-serious incidents or are expected to have undesirable side-effects that could have a significant impact on the benefit-risk assessment.

 

This may have led to or may result in risks to patients, users, or other people’s health or safety that are unacceptable when weighed against the intended benefits.

 

These incidents should be clearly identified and recorded in the manufacturer’s IFU, clinically well recognized and well documented in the technical documentation with an appropriate risk assessment, and clinically acceptable in terms of individual patient benefit.

Field Safety Corrective Action (FSCA)

US FDA Approval

The manufacturer’s measure to reduce the risk of serious health deterioration or death associated with the use of an already commercialized medical device. Such actions, whether linked to direct or indirect harm, must be reported and notified to the users through the Field Safety Notice (FSN).

What to be Reported?

US FDA Approval

  • Device-specific Reports – The deterioration or malfunction of medical devices that lead to or might lead to death or serious deterioration of the state of health,
  • FSCA Reports – The medical device that has been subjected to FSCA such as medical device return, modification, etc.
  • Use Errors – User errors that may lead to death or serious health deterioration needs to be reported.
  • Periodic Summary Reporting – Some incidents are appropriate for reporting using periodic summary reporting.
  • Trend Reporting – A reporting type used when there is a statistical 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 may have led to or may result in risks to patients, users or other people’s health or safety that are unacceptable when weighed against the intended benefits.