Malfunction

Malfunctions matter most in vigilance. Under FDA's Medical Device Reporting rule (21 CFR 803), a malfunction is reportable when the device or a similar one would be likely to cause or contribute to a death or serious injury if it happened again. In the EU, a malfunction becomes reportable when it led, or might have led, to a serious incident.

Malfunction means the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. The intended performance of a device refers to the intended use for which the device is labeled or marketed, as defined in § 801.4 of this chapter.

21 CFR, 803.3

failure of an investigational medical device (3.29) to perform in accordance with its intended purpose when used in accordance with the instructions for use or CIP, or IB

ISO 14155:2020, clause 3.33

See also the following definition of a ‘malfunction’ provided in EN ISO 14155:2020: ‘A malfunction is a failure of a device to perform in accordance with its intended purpose when used in accordance with the manufacturer’s instructions for use or to meet its performance specifications’.

MDCG 2023-3 Rev.2, Question 3, footnote 12 (quoting EN ISO 14155:2020)

Any failure of an device for performance study to perform in accordance with its intended use when used in accordance with the instructions for use or performance study plan. See ISO 20916 section 3.27.

MDCG 2024-4, Section 4.12

21 CFR 803 ties intended performance to the labeling and counts every labeling claim as a performance specification. The ISO 14155 wording quoted in MDCG 2023-3 refers to failure to perform according to the intended purpose when used as instructed, and MDCG 2024-4 applies the same idea to devices for performance study, adding the performance study plan.