Our glossary for guidance - Letter A

ABC analysis is a method from business administration and is also known as programme structure analysis. This method helps to set priorities in a situation analysis. These priorities can be visually represented via a Lorenz curve.

The abscissa denotes the horizontal orientation of a coordinate system.

Mnemonic: The ordinate goes upwards and the abscissa in the other direction.

The term ‘Absorption’ in the context of implantable devices refers to the degradation of a material within the body and the metabolic elimination of the resulting degradation products from the body. It does not apply to those substances that are excreted without modification from the body, e.g. insufflation gases for the abdominal cavity or laparoscopic and endoscopic procedures.

[Definition of term as defined in MDCG 2021-24 No. 3.1.8]

‘Accessory for a medical device’ 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).

[Definition according to (EU) 2017/745 Article 2 No. 2]

‘Accessory for an in vitro diagnostic medical device’ means 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).

[Definition according to (EU) 2017/746 Article 2 No. 4].

‘Accessory’ means an article which, whilst not being an in vitro diagnostic medical device, is intended specifically by its manufacturer to be used together with a device to enable that device to be used in accordance with its intended purpose.

For the purposes of this definition, invasive sampling devices or those which are directly applied to the human body for the purpose of obtaining a specimen within the meaning of Directive 93/42/EEC shall not be considered to be accessories to in vitro diagnostic medical devices.

[Definition according to (98/79/EC) Article 1 No. 2c]

'Accessory' means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device.

[Definition according to (93/42/EEC) Article 1 No. 2b]

The concept act by converting energy includes conversion of energy in the device and/or conversion at the interface between the device and the tissues or in the tissues. Electrodes intended for E.C.G. or E.E.G are normally not considered active devices because they do not normally act by conversion of energy.

[Definition of term as defined in MDCG 2021-24 No. 3.1.5]

Any active medical device, whether used alone or in combination with other medical devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities.

[Definition according to (93/42/EEC) Annex IX No. 1.6]

Active device intended for diagnosis and monitoring means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities. A device is considered to allow direct diagnosis when it provides the diagnosis of the disease or condition in question itself or when it provides decisive information for the diagnosis.

[Definition of term as defined in MDCG 2021-24 No. 3.1.5]

‘Active device intended for diagnosis and monitoring’ means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities.

[Definition according to (EU) 2017/745 Annex VIII Chapter I No. 2.5].

Active device 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.

[Definition of term as defined in MDCG 2021-24 No. 3.1.5]

‘Active device’ 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.

[Definition according to (EU) 2017/745 Article 2 No. 4]

An active implantable medical device is dependent on a power source for operation.

'Active implantable medical device' means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice , and which is intended to remain after the procedure.

[Definition according to (90/385/EEC) Article 1 No. 2c]

'Active medical device' means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity.

[Definition according to (90/385/EEC) Article 1 No. 2b]

Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices.

[Definition according to (93/42/EEC) Annex IX No. 1.4]

Active therapeutic device means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability.

[Definition of term as defined in MDCG 2021-24 No. 3.1.5]

‘Active therapeutic device’ means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability.

[Definition according to (EU) 2017/745 Annex VIII Chapter I No. 2.4]

Any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or handicap.

[Definition according to (93/42/EEC) Annex IX No. 1.5]

An Actor ID is the identifier issued to all actors registered in EUDAMED for their identification in the system. It will be automatically generated by EUDAMED and issued once the registration request is approved by the relevant competent authority.

[Definition according to MDCG 2021-13 rev.1 Terminology]

Value-adding activity on the product or a service

‘Adverse event’ means 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.

[Definition according to (EU) 2017/746 Article 2 No. 60]

‘Adverse event’ 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.

[Definition under (EU) 2017/745 Article 2 No. 57]

Adverse Event (AE)
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. (MDR Article 2(57))
Note:
a. This definition includes events that are anticipated as well as unanticipated events
b. This definition includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.

[Definition of the term according to MDCG 2020-10/1]

The affinity diagram, also called affinity board, belongs to the so-called "New Seven Management Tools N7 or M7". It can be used to organize the outcome of a brainstorming session by structuring ideas or different verbal statements.

‘Agglomerate’, 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.

[Definition according to (EU) 2017/745 Article 2 No. 20]

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

[Definition according to (EU) 2017/745 Article 2 No. 21]

Until 2010: Adolf Grimme Institute, today: Grimme Institute - Society for Media, Education and Culture Ltd.

This acronym stands for Arbeitsplatzgrenzwert (engl. limit value for workplaces)

AIDA stands for

• Attention
• Interest
• Desire
• Action

Acronym for German Medicines Act.

Are designed for use during anaesthesia with an anaesthetic breathing system (See e.g. EN ISO 80601-2-13:2012). Ventilators for critical care are usually invasive, which enables the ventilator machine to provide lung support for inspiration and expiration through tracheal intubation. However, most critical care ventilators allow non-invasive ventilation modes for critical care patients as well. Ventilators for non-critical care are usually non-invasive and therefore provide air pressure support to natural breathing through e.g. a facemask. Ventilators may offer different types of additional complementary functions that include:

• High flow oxygen supply (nasal high flow therapy);
• Monitoring systems;
• Nebulisation systems.

[Definition according to MDCG 2020-9 No. 2.1]

A substance or material; something that identifies or that is used to identify; a factor that establishes the nature of an entity or event; constituent of a sample with a measurable property.

[Definition according to MDCG 2020-16 rev.1 No. 2]
 

‘Analytical performance’ means the ability of a device to correctly detect or measure a particular analyte.

[Definition according to (EU) 2017/746 Article 2 No. 40].

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

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 40]

The capability of the method to distinguish between two close concentrations of the target marker/analyte.
Source: Iteration from several sources

[Definition according to MDCG 2022-2 No. 4]

The ability of an assay to measure in a sample a particular target measurand in the presence of for example other analyte/marker, matrix, interfering substances/organisms or cross-reactive species/agents.
Source: Iteration from several sources

[Definition according to MDCG 2022-2 No. 4]

Andon is to a tool of "visual management" and is used to make problems visible (on display panels) e.g. on production lines, in order to show a direct link between the colour displayed and the problem status.

(e.g. green = OK - no problem; orange = problem detected - can be solved within time, problem solution requested; red = not OK - problem cannot be solved within time - belt stop required).

Antibrainstorming is the opposite of brainstorming and deals with the negative view of what could go wrong.

ARD is a humorous acronym for "Alle reden darüber" (engl. Everybody is talking about it)

ASO is an acronym for the german work and social regulation.

ASQ stands for American Society for Quality

ASR is an outdated acronym for the workplace guidelines, which have been renamed the "Technical Rules for Workplaces".

An audit is a random check of the fulfilment of requirements and specifications. An audit often takes place within the framework of a quality management system.

The catalogue of measures is a collection of all findings together with standard points and, if applicable, recommendations for corrective measures.
The findings listed in the catalogue of measures often serve as a basis for the upcoming audit.

The audit follow-up concerns the weighting of all findings as well as the evaluation of the entire audit, i.e. whether the auditee passed or failed the audit. The follow-up also includes the documentation of the audit and the writing of the audit report together with the catalogue of measures.

The significance of a professional audit depends to a large extent on the preparation for the audit, but also on the questioning technique and the experience of the auditor. In order to objectify the audit, audits are often conducted according to company-specific or auditor-specific questionnaires.

An audit questionnaire serves as a guideline for the auditor. These questionnaires are often company-specific or auditor-specific (institution-specific). If necessary, they have an annually changing focus in order to determine the degree of implementation of the company-specific goals or standard-related goals.

The audit report is the result of an audit and should include the following points:

• Reason for the audit
• Audited area
• Process owner
• Audit participants
• Catalogue of measures with justification
• In the case of deviations, reference to applicable documents
• Audit result

(No points should be listed in the audit report that were not already dealt with during the audit or in the final discussion)

The result of an audit is usually announced in the final audit meeting and later documented in the audit report together with the corresponding findings in the catalogue of measures.

An auditor is a trained person who performs an audit and checks how the management system(s) in companies and organizations comply with the requirements of the relevant standards by questioning, observing and listening.

A general distinction is made between an internal and an external auditor.

The auditor examines and analyzes the organizational structures and work processes (according to the specification documents), checks and ensures compliance with external and internal company regulations, guidelines and instructions and / or translates the audit results into practical recommendations.

an organisation that legally represents a manufacturer in the EU, when the manufacturer is based outside the EU.

[Definition according to COVID-19 IVD-QA Abbreviations and Terms]

‘Authorised representative’ means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this Directive.

[Definition according to (98/79/EC) Article 1 No. 2g]

‘Authorised representative’ 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.

[Definition under (EU) 2017/745 Article 2 No. 32 also corresponds to definition under (EU) 2017/746 Article 2 No. 25]