In order to help medical devices manufacturer in their obligations regarding vigilance, the European Commission published a guidance to complement the current guidelines on medical devices vigilance system, MEDDEV 2.12-1 rev 8, 2013.
The new guidance clarifies the definition of a Field Safety Corrective Action (FSCA) to highlight that both the nature of the action and the reason behind it will define an action as a FSCA. It also modifies the definition of a Field Safety Notice (FSN) to clarify the target audience. Further clarifications are given regarding the implementation of a FSCA and the content of a FSN.
The document highlights that a new version of the Manufacturer’s Incident Report (MIR) is available since January 2019. This new form introduces a new structure and new fields that will be mandatory under the EU Medical Device Regulation (MDR)/In Vitro medical Device Regulation (IVDR) such as International Medical Device Regulators Forum (IMDRF) terminology, trend data, Single Registration Number (SRN) and Unique Device Identifier (UDI).
The Commission also wants to remind that some device specific vigilance guidance have been developed in the past years to help manufacturers of some specific devices (devices for cardiac ablation and coronary stents at the moment) to classify incidents and suggest method for reporting, and that they should be used in addition to the MEDDEV guidance.
Finally, the guidance clarifies when Competent Authorities should determine a Single Coordinating National Competent Authority or establish a vigilance taskforce, and how dissemination and exchange of information (via a National Competent Authority Report, NCAR) is done between CA using Eudamed (for EEA member States) or using IMDRF NCAR exchange for wider international communication.
All European Commission guidance and report forms regarding medical device vigilance system please click here.