Hi, I can't find the term Field Corrective Action in either 93/2/EC MDD or
MEDDEV 2-12-1. Can you point to the appropriate clause?
Regarding Field Safety Corrective Actions (FSCA) Section 5.4.4.1 of the Meddev, does say:
"The MANUFACTURER should issue a notification (see below) to the Competent Authorities of all countries affected at the same time and also to the National Competent Authority responsible for the MANUFACTURER or AUTHORISED REPRESENTATIVE"
also
"MANUFACTURERs should also include a copy of the FIELD SAFETY NOTICE to the Competent Authorities along with the notification. This should be done before or at the same time as FSCA is being issued."