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)

Adverse event

Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device. Under the IVDR: any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a performance study, whether or not related to the device for performance study.

Reference: MDR Article 2(57); IVDR Article 2(60)

AIDC — Automatic identification and data capture

A technology used to automatically capture data. AIDC technologies include bar codes, smart cards, biometrics and RFID.

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1

Analytical performance

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

Reference: IVDR Article 2(40)

Authorised representative

Any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation.

Reference: MDR Article 2(32); IVDR Article 2(25)

Basic UDI-DI — Basic UDI device identifier

The primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1

Benefit-risk determination

The analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer.

Reference: MDR Article 2(24); IVDR Article 2(17)

Borderline product

A product whose regulatory status is unclear — whether it is a device, a medicinal product, a cosmetic, a biocide or something else. Member States may ask the Commission to determine the status of a specific product or group of products by implementing act, after consulting the MDCG.

Reference: MDR Article 4; IVDR Article 3

CA — Competent authority

The national authority designated by a Member State to apply the regulations: designating and monitoring notified bodies, running market surveillance and vigilance, and authorising clinical investigations or performance studies. Each Member State has its own, and they act independently of one another.

Reference: MDR Article 101; IVDR Article 96

Calibrator

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

Reference: IVDR Article 2(55)

CAPA — Corrective and preventive action

The quality system process for investigating problems, eliminating their causes and preventing recurrence. Corrective action is defined in both regulations; the combined CAPA term comes from quality management practice rather than from the regulations themselves.

Reference: MDR Article 2(67); IVDR Article 2(70)

CE marking — CE marking of conformity

A marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing.

Reference: MDR Article 2(43); IVDR Article 2(35)

Classification — Classification of devices

The rules that assign a device to a risk class, which then determines the conformity assessment route and the level of notified body involvement. Under the MDR devices fall into classes I, IIa, IIb and III according to the rules in Annex VIII. Under the IVDR devices fall into classes A, B, C and D under a different Annex VIII rule set.

Reference: MDR Article 51 and Annex VIII; IVDR Article 47 and Annex VIII

Clinical performance

The ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer. Under the IVDR: the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user; 02017R0746 — EN — 10.01.2025 — 005.001 — 8.

Reference: MDR Article 2(52); IVDR Article 2(41)

Clinical benefit

The positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health. Under the IVDR: the positive impact of a device related to its function, such as that of screening, monitoring, diagnosis or aid to diagnosis of patients, or a positive impact on patient management or public health.

Reference: MDR Article 2(53); IVDR Article 2(37)

Clinical evidence

Clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer. Under the IVDR: clinical data and performance evaluation results, pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer.

Reference: MDR Article 2(51); IVDR Article 2(36)

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)

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)

Configuration

A combination of items of equipment, as specified by the manufacturer, that operate together as a device to achieve an intended purpose. The combination of items may be modified, adjusted or customized to meet specific needs. Configurations include inter alia: — gantries, tubes, tables, consoles and other items of equipment that can be configured/combined to deliver an intended function in computed tomography. — ventilators, breathing circuits, vaporizers combined to deliver an intended function in anaesthesia.

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1

Configurable device

A device that consists of several components which can be assembled by the manufacturer in multiple configurations. Those individual components may be devices in themselves. Configurable devices include computed tomography (CT) systems, ultrasound systems, anaesthesia systems, physiological Monitoring systems, radiology information systems (RIS).

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1