EU Issues Device Vigilance Guidance
The European Commission issued new guidance to clarify when devicemakers operating in the EU need to issue Field Safety Corrective Actions and how they should prepare Field Safety Notices under the new EU Medical Device Directives.
The guidance clarifies existing definitions and introduces a new manufacturer incident report and a new template for field safety notices. It also introduces device-specific vigilance guidance and provides more detail on coordinating vigilance activities with regulators.
Under the new EU regulations, devicemakers must maintain procedures to review post-market experience to ensure appropriate corrective actions are carried out, and they are required to report incidents and recalls to their national authorities.