MEDDEV 2.12-1 rev 6: GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM

EUROPEAN COMMISSION DG ENTERPRISE AND INDUSTRY

December 2009

FIELD SAFETY CORRECTIVE ACTION (FSCA)

A Field Safety Corrective Action is an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market. Such actions should be notified via a Field Safety Notice.

The FSCA may include

• the return of a medical device to the supplier;
• device modification;
• device exchange;
• device destruction;
• retrofit by purchaser of manufacturer's modification or design change;
• advice given by manufacturer regarding the use of the device (e.g. where the device is no longer on the market or has been withdrawn but could still possibly be in use e.g. implants or change in analytical sensitivity or specificity for diagnostic devices)

A device modification can include:

• permanent or temporary changes to the labelling or instructions for use;
• software upgrades including those carried out by remote access;
• modification to the clinical management of patients to address a risk of death or serious deterioration in state of health related specifically to the characteristics of the device. For example:
  • For implantable devices it is often clinically unjustifiable to explant the device. Corrective action taking the form of special patient follow-up, irrespective of whether any affected un-implanted devices remain available for return, constitutes FSCA.
  • For any diagnostic device (e.g. IVD, imaging equipment or devices) the recall of patients for retesting or the retest or review of previous results constitutes FSCA.
  • advice relating to a change in the way the device is used e.g. IVD manufacturer advises revised quality control procedure -use of third party controls or more frequent calibration or modification of control values for IVDs.