NIST GCR 01-815
A Guide to the EU Medical Device Directive

Malfunction Or Deterioration In The Characteristics and/or Performance Of A Device.

Malfunction or deterioration is a failure of a device to perform in accordance with its intended purpose when used in accordance with the manufacturer's instructions.

Note: A device that shows no malfunction or deterioration, but nevertheless has a characteristic that could lead to an incident, should be reported as a "Near Incident."

Inaccuracies in the instruction leaflet or instructions for use include omissions and deficiencies.

Note: An example of an omission is a failure to warn of a side effect that may be produced by the device working within specification; an example of a deficiency is a lack of clarity which leads, or could lead to, an injury.

Omissions do not include the absence of information that should generally be known by the intended user.

Any inaccuracy in the instructions which caused, or could cause, misuse or incorrect maintenance or adjustment should be reported.

2. Timescale For The Initial Reporting Of An Incident Or Near Incident

The times given below are the maximum elapsed times for determining the relevant facts and making an initial report.

The time runs from the manufacturer (or his distributor or Authorized Representative) first being informed of the incident, to the relevant Competent Authority receiving the notification from the manufacturer.

INCIDENTS: 10 DAYS

NEAR INCIDENTS: 30 DAYS

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