05 beo en glossary

A - C

.. means 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);

.. means 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;

.. means 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;

.. for the purposes of the definition of nanomaterial in point (18), means 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;

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

.. means 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;

.. means 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;

.. means 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;

.. means 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;

.. means information concerning safety or performance that is generated from the use of a device and is sourced from the following:

- clinical investigation(s) of the device concerned,

- clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated,

- reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated,

- clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up;

.. means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

.. means 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;

.. means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device;

.. means a document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation;

.. means 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;

.. means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.

.. is the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to:

  1. perform without losing or compromising the ability to perform as intended, and/or
  2. integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or
  3. be used together without conflict/interference or adverse reaction.

.. is the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to:

  1. perform without losing or compromising the ability to perform as intended, and/or
  2. integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or
  3. be used together without conflict/interference or adverse reaction.

.. means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;

.. means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection;

.. means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation;

.. means 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;