Analytical performance

The ability of a device to correctly detect or measure a particular analyte.

Reference: IVDR Article 2(40)

Compatibility

The ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to: (a) perform without losing or compromising the ability to perform as intended, and/or (b) integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or (c) be used together without conflict/interference or adverse reaction. Under the IVDR: the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to: (a) perform without losing or compromising the ability to perform as intended, and/or (b) integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or (c) be used together without conflict/interference or adverse reaction; 02017R0746 — EN — 10.01.2025 — 005.001 — 6.

Reference: MDR Article 2(25); IVDR Article 2(18)

Diagnostic specificity

The ability of a device to recognise the absence of a target marker associated with a particular disease or condition.

Reference: IVDR Article 2(49)

Diagnostic sensitivity

The ability of a device to identify the presence of a target marker associated with a particular disease or condition.

Reference: IVDR Article 2(50)

Indication — Indication for use

The clinical condition to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled by the device. Distinct from intended purpose, which describes the effect of the device: every device has an intended purpose, but not every device has an indication.

Reference: MDCG 2020-6

Intended use

Not defined in the MDR, which defines intended purpose instead. Guidance treats the two as carrying the same meaning, so a device file may use either term provided it does so consistently.

Reference: MDCG 2020-6

Intended purpose

The use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation. Under the IVDR: the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements or as specified by the manufacturer in the performance evaluation.

Reference: MDR Article 2(12); IVDR Article 2(12)

Interoperability

The ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to: (a) exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data, and/or (b) communicate with each other, and/or (c) work together as intended.

Reference: MDR Article 2(26); IVDR Article 2(19)

Likelihood ratio

The likelihood of a given result arising in an individual with the target clinical condition or physiological state compared to the likelihood of the same result arising in an individual without that clinical condition or physiological state.

Reference: IVDR Article 2(54)

Negative predictive value

The ability of a device to separate true negative results from false negative results for a given attribute in a given population; 02017R0746 — EN — 10.01.2025 — 005.001 — 9.

Reference: IVDR Article 2(53)

Performance of a device

The ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting that intended purpose.

Reference: IVDR Article 2(39)

Performance

The ability of a device to achieve its intended purpose as stated by the manufacturer.

Reference: MDR Article 2(22)

Positive predictive value

The ability of a device to separate true positive results from false positive results for a given attribute in a given population.

Reference: IVDR Article 2(52)

Predictive value

The probability that a person with a positive device test result has a given condition under investigation, or that a person with a negative device test result does not have a given condition.

Reference: IVDR Article 2(51)

Scientific validity of an analyte

The association of an analyte with a clinical condition or a physiological state.

Reference: IVDR Article 2(38)