Definitions

On this website you will find many terms that apply within the European legislation for medical devices. Below you will find an explanation of some of the most important terms.

Medical device: any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of, or compen­sation for, an injury or disability,
• investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
• providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by phar­macological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The following products shall also be deemed to be medical devices:

• devices for the control or support of conception;
• products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

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:

• concerning a physiological or pathological process or state;
• concerning congenital physical or mental impairments;
• concerning the predisposition to a medical condition or a disease;
• to determine the safety and compatibility with potential recipients;
• to predict treatment response or reactions;
• to define or monitoring therapeutic measures.

Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;

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.

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.

General safety and performance requirements: the MDR contains a list of requirements that every medical device must meet. These requirements are called the general safety and performance requirements and can be found in Annex I of the Regulation.

Audit: in the context of the MDR, this is a visit by a Notified Body or competent authority to a manufacturer where the quality management system and technical documentation is assessed.

Intended purpose: the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation.

Competent authority: competent government

CE: Conformité Européenne, or ''in accordance with European legislation''. This marking on a product indicates that the product has been developed and manufactured in accordance with the European rules that apply to it. The CE marking is also referred to as “EC marking” or “EC conformity marking”.

Conformity assessment: the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled.

Declaration of conformity: statement in which the manufacturer of a device declares that the device has been developed according to the MDR.

Manufacturer: a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manu­factured or fully refurbished, and markets that device under its name or trade mark.

Clinical evaluation: 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.

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

Quality management system: system for managing and controlling an organization with regards to quality. It ensures consistent design, development, production, installation and delivery of medical devices that are safe for their intended purpose.

Nanomaterial: a natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm. Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall also be deemed to be nanomaterials.

Standard: document with recognized agreements, specifications or criteria about a product, a service or a method. Standards in themselves do not yet have any legal relevance. They only get this through publication in the Official Journal of the European Union. The publication of these so-called harmonized standards means that the "presumption of conformity" takes effect. The user of the standard may therefore assume that he is behaving according to the law or directive. Harmonized standards allow you to prove that your products or services meet the general safety and performance requirements.

Notified Body: a conformity assessment body designated in accordance with the Regulation. Medical devices other than class I must be assessed by a notified body.

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).

Specimen receptacle: a device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.

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.

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;

Companion diagnostic: a device which is essential for the safe and effective use of a corresponding medicinal product to:

• identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
• 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.

Performance evaluation: an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device.