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)

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

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

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)

Custom-made device

Any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices.

Reference: MDR Article 2(3)

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)

Falsified device

Any device with a false presentation of its identity and/or of its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights.

Reference: MDR Article 2(9); IVDR Article 2(10)

Generic device group

A set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics.

Reference: MDR Article 2(7); IVDR Article 2(8)

Implantable device

Any device, including those that are partially or wholly absorbed, which is intended: — to be totally introduced into the human body, or — to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device.

Reference: MDR Article 2(5)

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)

Invasive device

Any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.

Reference: MDR Article 2(6)

Investigational device

A device that is assessed in a clinical investigation.

Reference: MDR 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)

MDSW — Medical device software

Software intended to be used, alone or in combination, for a medical purpose as set out in the definition of a medical device. Guidance distinguishes software that drives or influences a hardware device from software with an independent medical purpose, which is a device in its own right.

Reference: MDCG 2019-11