Guide to Field Safety Corrective Actions for Medical Devices and In-vitro Diagnostic Medical Devices
01 August 2012
The Irish Medicines Board (IMB) is the Competent Authority (CA) in Ireland for medical devices. This guide outlines how to achieve an effective interface between the legal manufacturers or their authorised representatives and the IMB in the event of a field safety corrective action (FSCA) for a medical device, active implantable medical device or an in-vitro diagnostic medical device and associated accessories. It aims to describe what an FSCA is and clarifies the role played by the legal manufacturer or authorised representative and by the IMB in ensuring that an efficient and effective FSCA is carried out.
This guide has been updated.
Guide to Field Safety Corrective Actions for Medical Devices and In-vitro Diagnostic Medical Devices
A version of the guide with changes tracked is attached below.
Guide to Field Safety Corrective Actions for Medical Devices and In-vitro Diagnostic Medical Devices with changes tracked