Accessory for an in vitro diagnostic medical device

An article which, whilst not being itself an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable the in vitro diagnostic medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the in vitro diagnostic medical device(s) in terms of its/their intended purpose(s).

Reference: IVDR Article 2(4)

Analytical performance

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

Reference: IVDR Article 2(40)

Calibrator

A measurement reference material used in the calibration of a device.

Reference: IVDR Article 2(55)

Companion diagnostic

A device which is essential for the safe and effective use of a corresponding medicinal product to: (a) identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or (b) identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product.

Reference: IVDR Article 2(7)

Control material

A substance, material or article intended by its manufacturer to be used to verify the performance characteristics of a device.

Reference: IVDR Article 2(56)

Device for near-patient testing

Any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional.

Reference: IVDR Article 2(6)

Device for performance study

A device intended by the manufacturer to be used in a performance study. A device intended to be used for research purposes, without any medical objective, shall not be deemed to be a device for performance study.

Reference: IVDR Article 2(45)

Device for self-testing

Any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services.

Reference: IVDR Article 2(5)

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)

EURL — European Union reference laboratory

A laboratory designated under the IVDR to verify the performance of class D devices and check batches, and to provide scientific and technical assistance to the Commission and Member States. There is no direct MDR equivalent.

Reference: IVDR Article 100

In vitro diagnostic medical device

Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following: (a) concerning a physiological or pathological process or state; (b) concerning congenital physical or mental impairments; (c) concerning the predisposition to a medical condition or a disease; (1) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery (OJ L 157, 9.6.2006, p. 24). 02017R0746 — EN — 10.01.2025 — 005.001 — 4 (d) to determine the safety and compatibility with potential recipients; (e) to predict treatment response or reactions; (f) to define or monitoring therapeutic measures. Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices.

Reference: IVDR Article 2(2)

Interventional clinical performance study

A clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment.

Reference: IVDR Article 2(46)

Kit

A set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof.

Reference: IVDR Article 2(11)

LDT — Laboratory developed test

An IVD developed and used within a single laboratory rather than placed on the market. In the EU these fall under the health institution exemption in IVDR Article 5(5) rather than being a separate regulatory category, so the exemption conditions determine what is permitted.

Reference: IVDR Article 5(5)

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)

PEP — Performance evaluation plan

The plan setting out how scientific validity, analytical performance and clinical performance will be demonstrated for an IVD, including the intended purpose, the analyte or marker concerned, the characteristics to be evaluated and the acceptance criteria.

Reference: IVDR Annex XIII Part A point 1.1

PER — Performance evaluation report

The document in which the manufacturer assesses the scientific validity, analytical performance and clinical performance reports together, and states the clinical evidence supporting the intended purpose. It sits in the technical documentation alongside the performance evaluation plan.

Reference: IVDR Annex XIII Part A point 1.3.2

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)