MDCG 2019-16 - Post-Market Surveillance and Vigilance

MDCG 2019-16 is a guidance document from the Medical Device Coordination Group (MDCG), which is a group of experts established by the European Commission to provide guidance on the implementation of EU medical device regulations. The document provides guidance on post-market surveillance (PMS) and vigilance activities for medical device manufacturers and authorized representatives.

Post-market surveillance is the ongoing monitoring of the safety and performance of medical devices after they have been placed on the market. It is a key element of the EU's regulatory framework for medical devices and is intended to ensure the continued safety and performance of devices that are already in use.

Vigilance is the process of monitoring, collecting, assessing, and reporting adverse events related to medical devices. Manufacturers and authorized representatives are responsible for monitoring the devices they place on the market, and for reporting any incidents that could compromise the safety or performance of the device to the appropriate regulatory authorities.

The guidance in MDCG 2019-16 provides recommendations on how manufacturers and authorized representatives can fulfill their responsibilities for PMS and vigilance, including:

  • Developing and implementing a PMS plan that describes the activities and procedures that will be used to monitor the safety and performance of their devices
  • Establishing a system for collecting, assessing, and reporting adverse events related to their devices
  • Ensuring that the necessary resources are available to carry out PMS and vigilance activities
  • Keeping records of PMS and vigilance activities, including any incidents that have been reported

The guidance also includes information on how to report adverse events, how to evaluate the significance of an incident, and how to decide on appropriate corrective and preventive action in the event of an adverse event.

In short, the MDCG 2019-16 is a guidance from EU which provides the manufacturers and authorized representative of Medical Devices the standard on how to conduct the Post-Market Surveillance (PMS) and Vigilance activities for their devices in EU market. It is intended to ensure the safety and performance of Medical Devices which are already in use, and to ensure companies are following their legal obligations.