Background to Field Safety Notices for medical devices

Under European legislation, manufacturers or their European representatives, are obliged to inform all relevant Competent Authorities (i.e. MHRA in the UK) concerning any systematic recall (field safety corrective action¹) of devices being undertaken for technical or medical reasons connected with the characteristics or performance of a device, where death or serious injury might result. Manufacturers use Field Safety Notices² (sometimes called Dear Doctor Letters or Advisory Notices) to tell their customers about field safety corrective actions that they are undertaking.

MHRA assesses and updates the status of these FSCAs and their associated Field Safety Notices as their investigations progress.

The three status options are:

  • This FSCA is currently being assessed by MHRA – further advice may be issued later
  • MHRA has assessed this FSCA and does not intend to issue further advice
  • MHRA has assessed this FSCA and has issued further advice (links to the relevant advice will be provided)

These webpages provide a new central source of public safety information about medical devices known to be on the UK market. They will cover a more comprehensive set of safety issues than MHRA has previously made available. We will continue to monitor progress with the FSCA via feedback from the manufacturer or their representative. We recommend that all MDLOs and other regular users of these webpages register to receive e-mail alerts for all new FSNs and status updates.

Only those FSCAs that result in Medical Device Alerts (together with any necessary supplementary material) will be distributed via the Safety Alert Broadcast system and require separate feedback on action taken within the health service.

The following definitions are taken from the current draft MEDDEV 2.12-1 rev 5 - GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM, June 2006

1- 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.

NOTE 1:

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 serious deterioration in state of health or death 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.

NOTE 2: This guideline uses the definition of FSCA as synonym for recall mentioned in Article 10(1), paragraph 1b) of the Medical Devices Directive (external link) and Article 11 In Vitro Diagnostic Medical Devices Directive (external link) since there is no harmonised definition of recall.

2 - Field Safety Notice (FSN)

A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action

FSCA and FSN Forms

Forms for manufacturer’s or their authorised representative to use to submit Field Safety Corrective Action reports and Field Safety Notices are provided on our devices reporting section.


Page last modified: 07 February 2008