Accessory for a medical device

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

Reference: MDR Article 2(2)

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)

Active device

Any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device.

Reference: MDR 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)

Agglomerate

For the purposes of the definition of nanomaterial in point (18), a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components.

Reference: MDR Article 2(20)

Aggregate

For the purposes of the definition of nanomaterial in point (18), a particle comprising of strongly bound or fused particles.

Reference: MDR Article 2(21)

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

AIMDD — Active Implantable Medical Devices Directive 90/385/EEC

The directive that governed active implantable devices such as pacemakers and implantable defibrillators before the MDR, repealed by the MDR subject to transitional provisions.

Reference: MDR Article 122

Analytical performance

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

Reference: IVDR Article 2(40)

Annex XVI products — Products without an intended medical purpose

Groups of products brought within the MDR despite having no medical purpose, including coloured contact lenses, products for liposuction or lipoplasty, dermal fillers, equipment for high-intensity electromagnetic radiation such as lasers used cosmetically, and brain stimulation equipment.

Reference: MDR Article 1(2) and Annex XVI

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

BtX — Breakthrough device

A device introducing a high degree of novelty in its technology, the related clinical procedure, or its application in clinical practice, and expected to deliver a significant positive clinical impact for a life-threatening or irreversibly debilitating disease — either against available alternatives and the state of the art, or by meeting an unmet medical need. A guidance concept rather than a defined legal status.

Reference: MDCG 2025-9

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)

CDP — Clinical development plan

The part of the clinical evaluation plan setting out the progression of clinical investigations, from exploratory work such as first-in-human or feasibility studies through to confirmatory investigations, together with the milestones and acceptance criteria along the way.

Reference: MDR Annex XIV Part A point 1(a)

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)