Our glossary for guidance

EU Medical Device Regulation.

On 26 May 2017, this EU regulation became binding in all EU member states and replaces the EU directives within the transition period of four years. The AIMD (90/385/EEC) and MDD (93/42/EEC) were replaced by the MDR (2017/745 EU) on 26 May 2021.

EU Regulation on In Vitro Diagnostic Medical Devices (In Vitro Diagnostics Regulation).

On 26 May 2017, this EU regulation came into binding force in all EU member states and replaces the EU directive within the transition period of five years. The IVDD (98/79/EC) will be replaced by the IVDR (2017/746 EU) on 26 May 2022.

100-percent test is a method that corresponds to the inspection of all units of an inspection lot. A distinction must be made as to whether this measure refers only to a specific test criteria or to the entire specification.

14 Points for Management include

1. Create constancy of purpose toward improvement of product and service, with the aim to become competitive and to stay in business and to provide jobs.
2. Adopt the new philosophy. We are in a new economic age. Western management must awaken to the challenge, must learn their responsibilities, and take on leadership for change.
3. Cease dependence on inspection to achieve quality. Eliminate the need for inspection on a mass basis by building quality into the product in the first place.
4. End the practice of awarding business on the basis of price tag. Instead, minimize total cost. Move toward a single supplier for any one item, on a long-term relationship of loyalty and trust.
5. Improve constantly and forever the system of production and service, to improve quality and productivity, and thus constantly decrease costs.
6. Institute training on the job.
7. Institute leadership. The aim of supervision should be to help people and machines and gadgets to do a better job. Supervision of management is in need of overhaul, as well as supervision of production workers.
8. Drive out fear, so that everyone may work effectively for the company.
9. Break down barriers between departments. People in research, design, sales, and production must work as a team, to foresee problems of production and in use that may be encountered with the product or service.
10. Eliminate slogans, exhortations, and targets for the work force asking for zero defects and new levels of productivity. Such exhortations only create adversarial relationships, as the bulk of the causes of low quality and low productivity belong to the system and thus lie beyond the power of the work force.
11. Eliminate work standards (quotas) on the factory floor. Substitute leadership. Eliminate management by objective. Eliminate management by numbers, numerical goals. Substitute leadership.
12. Remove barriers that rob the hourly worker of his right to pride of workmanship. The responsibility of supervisors must be changed from sheer numbers to quality. Remove barriers that rob people in management and in engineering of their right to pride of workmanship. This means, inter alia, abolishment of the annual or merit rating and of management by objective.
13. Institute a vigorous program of education and self-improvement.
14. Put everybody in the company to work to accomplish the transformation. The transformation is everybody’s job.

Source: Deming, W. Edwards. Out of The Crisis (MIT Press) (pp. 23-24), 1982

The three MU`s are a component of KAIZEN and refer to the three central causes of error

• Muda (waste of resources) (see 7 types of waste)
• Muri (overload related to employees and machines)
• Mura (imbalance or irregular processes)

The 4D report is a document that is used in the processing of internal complaints. This acronym stands for the four underlying process steps (disciplines):

• D1 - Error description
• D2 - Analyse cause(s) of error
• D3 - Determine immediate measures
• D4 - Establish corrective measures

The 4M refer to the original four branches of the Ishikawa diagram, which target possible causes of problems. Thereby the 4M stand for

• Man
• Machine
• Material and
• Method

The 4P marketing matrix is a term from business administration and refers to the four different "policies":

• Product policy
• Pricing policy
• Communication policy
• Distribution policy

The 5 Whys is a method for cause-effect analysis. The purpose of this method is to find the real cause of the problem that has occurred - as well as to safeguard the remedial action that has been identified.

Note: The number of whys is not limited to five! It should be continued until the real cause is found. This can already be achieved after asking three times.

The 5A methodology is a modified version of the 5S method and stands for:

• Sorting out (Aussortieren)
• Tidying up or ergonomically arranged work equipment (Aufräumen bzw. ergonomisch angeordnete Arbeitsmittel)
• Workplace cleanliness (Arbeitsplatzsauberkeit)
• Make arrangement a rule (Anordnung zur Regel machen)
•  Adhere to and improve all points (Alle Punkte einhalten und verbessern)

The 5S methodology is a component of KAIZEN and refers to the five principles for workplace design that are the basis for efficient and error-free work processes:

• Seri (tidy up)
• Seiton (Same place for the same object)
• Seiso (Keeping the workplace continuously clean)
• Seiketsu (standardize work processes)
• Shitsuke (Keep order and cleanliness)

The Six Thinking Hats by Dr. Edward de Bono is a creative technique for problem solving. Each hat represents a different perspective on a particular issue and is useful to prevent narrow thinking.

1. White Hat: Facts
2. Green Hat: Creativity
3. Yellow Hat: Benefits
4. Black Hat: Cautions
5. Red Hat: Feelings
6. Blue Hat: Procrss

The 635 method is a brainwriting technique (a form of creative techniques) and aims to find unusual ideas for problemsolving.
With this method, you can generated up to 108 ideas within 30 minutes (6 participants x 3 ideas x 6 lines).

To use this method you need:

• Equal-sized sheet with three columns and six rows each (18 boxes).
• Each participant (ideally six) formulates three ideas (one per column) in the first row.
• Each sheet is passed clockwise after a time reasonable for the the problem that needs to be solved (approx. 3-5 minutes).
• The next participant takes up the ideas that have already been mentioned and tries to develop them further.

The 6Rs are a lean management tool and aimed at optimal customer orientation:

• the right part or product
• in the right quantity
• at the right time
• at the right place
• in the right quality
• at the right price.

The 6W method uses the well-known "who, what, where, when, how and why" and combines them to a total of 36 questions. Each of the listed 6Ws is questioned six times with the same W.

1. What
2. Why
3. Where
4. Who
5. When
6. Which

The idea of asking six questions to analyse a project or problem comes from a poem by the famous poet Rudyard Kipling. However, the original poem mentioned 5Ws and an H. this is the more common approach than the 6Ws.

The "seven fatal diseases of a management system" described by Deming are:

1. Lack of a fixed organisational purpose
2. Emphasis on short-term profit
3. Annual evaluation, performance review and personal review system
4. High turnover in organisational leadership, jumping from company to company
5. Use of metrics by management - ignoring those that are unknown or unquantifiable
6. Excessive social costs
7. Excessive costs from product liability judgements

Waste in this context refers to the wasting of time or resources and does not create value. In particular there are the following seven types of waste (alternatively: TIMWOOD):

• T – Transport
• I – Inventory
• M – Motion
• W – Waiting
• O – Over-Production
• O – Over-Engineering
• D – Defects

The 8D report is a document that is used in the processing of a complaint. The acronym stands for the eight process steps (disciplines):

• D1 - Assembling the team
• D2 - Describing the problem
• D3 - Determine immediate measures
• D4 - Analyse the cause(s) of the problem
• D5 - Plan corrective action
• D6 - Implement corrective actions
• D7 - Prevent recurrence of error
• D8 - Appreciate the team's performance

The 8D methodology parallels the DMAIC methodology on which Six Sigma is based, with the disciplines D1, D2 and D5 corresponding to the "D" Define process, D3, D5 and D6 to the "I" Improve process, D4 to the "M" Measure or "A" Analyze process and D7 to the "C" Control process.

COUNCIL DIRECTIVE of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices.

Medical Device Directive: COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices.

DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998 on in vitro diagnostic medical devices.

The A3 problem-solving report is a document that is used for problemsolving and decision-making. This report should easily fit on one page. This acronym stands for the format DIN A3, which is the largest format that can be sent by fax. It is based on nine process steps (disciplines):

• D1 – Background and team building
• D2 – Description of the problem (e.g. pairwise comparison)
• D3 – Set goals and targets
• D4a – Root cause analysis (e.g. Ishikawa-diagramm)
• D4b – Root cause analysis (e.g. 5x Whys)
• D5 – Define and implement countermeasures
• D6 – Follow up
• D7 – Ensure successful solution
• D8 – Standartize or modify process
• D9 – Conclusion and break-up of the team

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]

Business-to-Business stands for the communication and trade relationship between at least two organizations.

Business-to-Consumer or Business-to-Client stands für the communication and trade relationship between an organizations and a private individual.

Baka-yoke is the predecessor of poka-yoke and means "foolproof" (baka = fool/idiot and yoke = avoidance), but the term was not very flattering and was renamed poka-yoke by its inventor Shigeo Shingo.

BAM is the acronym for Bundesanstalt für Materialforschung und -prüfung (engl. Federal Institute for Materials Research and Testing)

A defined amount of material, either starting material, intermediate or finished product which is uniform in its properties and has been produced in one process or series of processes.
[vgl. EN 13975:2003]

[Definition according to MDCG 2022-3 No. 3.2]

The BCG matrix developed by the Boston Consulting Group shows the company's average market growth (ordinate) and relative market share (abscissa) within a portfolio matrix.

BDI stands for Bundesverband der Deutschen Industrie (engl.Federation of German Industries)

Shortcut for Beauftragter der Oberesten Leitung (engl. Representative of the Chief Executive)

‘Benefit-risk determination’ 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.

[Definition under (EU) 2017/745 Article 2 No. 24 also corresponds to definition under (EU) 2017/746 Article 2 No. 17]

Abbreviation for the Federal Institute for Drugs and Medical Devices

Short for professional associations (german: Berufsgenossenschaften)

Employer's Liability Insurance Association for the Construction Industry

Employer's Liability Insurance Association for Energy, Textiles, Electrical and Media Products.

Employer's Liability Insurance Association for Raw Materials and the Chemical Industry.

Employer's Liability Insurance Association for Transport and Traffic.

Employer's Liability Insurance Association for Wood and Metal.

Employer's Liability Insurance Association for Trade and Goods Distribution.

Short for corporate health management (german: Betriebliches Gesundheitsmanagement)

Employer's Liability Insurance Association for the Food and Hospitality Industry.

Employer's Liability Insurance Association for Health Services and Welfare

A tissue made of blood cells and blood plasma (fluid). It functions as a transport organ, has regulatory functions and goes to almost all parts of the body via the vascular system.

The liquid intercellular substance in the blood.

Acronym for the Federal Ministry of Economics and Technology.

Any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.

[Definition of term as defined in MDCG 2021-24 No. 3.1.4]

Any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.

[Definition according to (93/42/EEC) Annex IX No. 1.2]

‘Body orifice’ means any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.

[Definition according to (EU) 2017/745 Annex VIII Chapter I No. 2.1]

Bottom-up is a direction of a process. Within management theory, this refers to an emphatically motivating and collegial style of leadership in order to be able to use the abilities of all employees.

Brainstorming is a method of collecting ideas developed by Alex F. Osborn and was further developed by Charles Hutchison Clark. It is important to allow all ideas to be collected without evaluation and also to allow cross-fertilisation of ideas.

Brainwriting is a variation of brainstorming for groups to allow ideas to flow in a creative atmosphere, for example through the 6-3-5 method or mindmapping.

Abbreviation for employee suggestion scheme

Cause Effect Diagram

Cause and effect matrix or prioritisation matrix.

Café to Go is a creativity technique and describes how the collective knowledge of a group (8-20 participants in larger groups) can be used to solve interdisciplinary problems in a structured, targeted and fast way. In different groups, ideas and problems are written directly on the tablecloths at small, individual tables. The groups change tables and work out further ideas, taking into account the existing notes, until a consensus is reached.

‘Calibrator’ means a measurement reference material used in the calibration of a device.

[Definition according to (EU) 2017/746 Article 2 No. 55].

CAPA is an acronym for Corrective Actions and Preventive Actions and is used to sustainably correct a defect and prevent its recurrence. The CAPA process is thus the equivalent of the 8D report, which is used in different industries (8D report e.g. automotive and CAPA e.g. medical devices industry).

‘CE marking of conformity’ or ‘CE marking’ 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.

[Definition under (EU) 2017/745 Article 2 No. 43 also corresponds to definition under (EU) 2017/746 Article 2 No. 35]

Symbol “CE” marked on the product, demonstrating that the product satisfies the applicable EU requirements.

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

CE Marking on a product to signify that it meets the legal requirements to be sold on the extended Single Market in the European Economic Area (EEA).

[Definition of the term according to MDCG 2021-6 Abbreviations]

Shortcut for Clinical Evaluation Assessment Report.

[Definition of the term according to MDCG 2020-13 Acronyms]

Shortcut for Clinical Evaluation Consultation Procedure.

[Definition of the term according to MDCG 2020-13 Acronyms]

U-shaped arrangement of the machines according to their actual process sequence for optimised routes and flexible use of labour to be able to compensate for fluctuations in the process.

European Committee for Standardisation

European Committee for Electrotechnical Standardization

Central circulatory system means the following blood vessels:

• arteriae pulmonales
• arteriae cerebrales
• truncus brachiocephalicus
• aorta ascendens
• aorta descendens bis zur bifurcatio aortae
• arteriae coronariae
• venae pulmonales
• vena cava superior
• arteria carotis communis
• arteria carotis externa
• arcus aortae
• arteria carotis interna
• venae cordis
• vena cava inferior

[Definition of term as defined in MDCG 2021-24 No. 3.1.4]

For the purposes of this Directive, 'central circulatory system' means the following vessels:

• arteriae pulmonales,
• aorta ascendens,
• arteriae coronariae,
• arteria carotis communis,
• arteria carotis externa,
• arteria carotis interna,
• arteriae cerebrales,
• truncus brachicephalicus,
• venae cordis,
• venae pulmonales,
• vena cava superior,
• vena cava inferior.

[Definition according to (93/42/EEC) Annex IX No. 1.7]

‘Central circulatory system’ means the following blood vessels:

• arteriae pulmonales
• arteriae cerebrales
• truncus brachiocephalicus
• aorta ascendens
• aorta descendens bis zur bifurcatio aortae
• arteriae coronariae
• venae pulmonales
• vena cava superior
• arteria carotis communis
• arteria carotis externa
• arcus aortae
• arteria carotis interna
• venae cordis
• vena cava inferior

[Definition according to (EU) 2017/745 Annex VIII Chapter I No. 2.6]

Central nervous system means the brain, meninges and spinal cord.

[Definition of term as defined in MDCG 2021-24 No. 3.1.4]

For the purposes of this Directive, 'central nervous system' means brain, meninges and spinal cord.

[Definition according to (93/42/EEC) Annex IX No. 1.8]

‘Central nervous system’ means the brain, meninges and spinal cord.

[Definition according to (EU) 2017/745 Annex VIII Chapter I No. 2.7].

Shortcut for Clinical Evaluation Report.

[Definition of the term according to MDCG 2020-13 Acronyms]

3rd party audit by an independent external auditor e.g., by an approved certification body.

Reference material, accompanied by a certificate, one or more whose property values are certified by a procedure which establishes its traceability to an accurate realization of the unit in which the property values are expressed, and for which each certified value is accompanied by an uncertainty at a stated level of confidence.

[Definition according to MDCG 2022-2 No. 4, also corresponds to WHO TGS-8 definition: Quality control for in vitro diagnostic medical devices for WHO prequalification]

Measurement method which has been certified to show appropriate trueness and precision for its intended purpose and has been officially defined as reference method by a competent body.

[Definition according to MDCG 2022-2 No. 4, also corresponds to WHO TGS-8 definition: Quality control for in vitro diagnostic medical devices for WHO prequalification]

Christian Trade Union Federation of Germany

The Continuous Improvement Process (CIP) is usually equated with the Japanese KAIZEN, since CIP is also about continuous improvement in small steps to make companies competitive. CIP refers to product, process and service quality.

Shortcut for Clinical Investigation Plan.

[Definition of term as per MDCG 2021-6 Abbreviations and MDCG 2020-13 Acronyms]

Clinical investigation identification number, generated by Eudamed for clinical investigations under the Medical Device Directives.

[Definition of terms according to MDCG 2019-9 Abbreviations]

Devices intended to be used for blood grouping, or to determine foeto-maternal blood group incompatibility, or for tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration, are classified as class C, except when intended to determine any of the following markers:

• ABO system [A (ABO1), B (ABO2), AB (ABO3)];
• Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)];
• Kell system [Kel1 (K)];
• Kidd system [JK1 (Jka), JK2 (Jkb)];
• Duffy system [FY1 (Fya), FY2 (Fyb)]

Note: Please see MDCG 2020-167 (Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746) for examples of devices falling in Class D.

[Definition according to MDCG 2022-3 No. 3.1, also corresponds to definition under (EU) 2017/746 Annex VIII Section 2 Rule 2]

The IVDR refers to class D devices in rules 1 and 2 of Annex VIII as follows: Devices intended to be used for the following purposes are classified as class D:

• detection of the presence of, or exposure to, a transmissible agent in blood, blood components, cells, tissues or organs, or in any of their derivatives, in order to assess their suitability for transfusion, transplantation or cell administration;
• detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation;
• determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management.

[Definition according to MDCG 2022-3 No. 3.1, also complies to definition under (EU) 2017/746 Article 47(I) & Annex VIII Section 2 Rule 1]

‘Clinical benefit’ means the positive impact of a device related to its function, such as that of screening, monitoring, diagnosis or aid to diagnosis of patients, or a positive impact on patient management or public health.

[Definition according to (EU) 2017/746 Article 2 No. 37]

The positive impact of a device related to its function, such as that of screening, monitoring, diagnosis or aid to diagnosis of patients, or a positive impact on patient management or public health.

Note: It should be recognized that the concept of clinical benefit for in vitro diagnostic medical devices is fundamentally different from that which applies in the case of pharmaceuticals or of therapeutic medical devices, since the benefit of in vitro diagnostic medical devices lies in providing accurate medical information on patients, where appropriate, assessed against medical information obtained through the use of other diagnostic options and technologies, whereas the final clinical outcome for the patient is dependent on further diagnostic and/or therapeutic options which could be available.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 (37) and recital 64]

‘Clinical benefit’ 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.

[Definition according to (EU) 2017/745 Article 2 No. 53]

‘Clinical data’ 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.

[Definition according to (EU) 2017/745 Article 2 No. 48]

‘Clinical evaluation’ 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.

[Definition according to (EU) 2017/745 Article 2 No. 44]

‘Clinical evidence’ means clinical data and performance 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;

[Definition according to (EU) 2017/746 Article 2 No. 36]

Clinical data and performance 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.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 36]

‘Clinical evidence’ 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.

[Definition according to (EU) 2017/745 Article 2 No. 51]

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

[Definition according to (EU) 2017/745 Article 2 No. 47]

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

[Definition according to (EU) 2017/745 Article 2 No. 45]

‘Clinical performance’ means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user.

[Definition according to (EU) 2017/746 Article 2 No. 41]

The ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 41] ]

‘Clinical performance’ 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.

[Definition according to (EU) 2017/745 Article 2 No. 52]

Canadian Medical Devices Conformity Assessment System.

Carcinogenic, Mutagenic or toxic to Reproduction.

[Definition of terms according to MDCG 2019-9 Abbreviations]

CNX analysis is an abbreviation for Constant-Noise-Exchangeable-Analyze, which examines the identified causes for their ability to change.

A person or organization commissioning an audit appoints an auditor or a team of auditors to conduct audits within its own organization or outside its own organization (but on a contractual basis).

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.

[Definition according to MDCG 2022-3 No. 3.3, also corresponds to definition under (EU) 2017/746 Article 2 No. 74]

‘Common specifications’ (CS) 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.

[Definition under (EU) 2017/745 Article 2 No. 71 also corresponds to definition under (EU) 2017/746 Article 2 No. 74]

‘Companion diagnostic’ means 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.

[Definition according to (EU) 2017/746 Article 2 No. 7].

Company-Wide Quality Control (CWQC) corresponds to today's Total Quality Control (TQC). This is mainly based on the TQM model, but differs from it in its strong employee orientation and the distribution of quality tasks throughout the company (decentralisation of quality tasks).

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

(a) perform without losing or compromising the ability to perform as intended, and/or

(b) integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or

(c) be used together without conflict/interference or adverse reaction.

[Definition under (EU) 2017/745 Article 2 No. 25 also corresponds to definition under (EU) 2017/746 Article 2 No. 18]

a government body that implements and enforces legislation, in this case in the field of in vitro diagnostic medical devices.

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

A compliance audit deals with conformity with internal regulations, guidelines (e.g. antitrust law, etc.) and external directives, regulations and laws, etc.

CON is an English acronym and stands for "Consultancy or contracted".

Is a device intended to be used for the confirmation of a reactive result from a first line assay.

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

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

[Definition under (EU) 2017/745 Article 2 No. 41 also corresponds to definition under (EU) 2017/746 Article 2 No. 33]

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

[Definition under (EU) 2017/745 Article 2 No. 40 also corresponds to definition under (EU) 2017/746 Article 2 No. 32]

See control charts (where chart stands for diagram, not a map).

A quality management tool to make processes visible.

‘Control material’ means a substance, material or article intended by its manufacturer to be used to verify the performance characteristics of a device.

[Definition according to (EU) 2017/746 Article 2 No. 56]

Cost of Poor Quality

Core processes include all value-adding processes (e.g. service, production, etc.).

Corporate governance or principles of corporate management represent the legal and factual regulatory framework for the management and supervision of companies. This serves the welfare of the relevant stakeholders.

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

[Definition under (EU) 2017/745 Article 2 No. 67 also corresponds to definition under (EU) 2017/746 Article 2 No. 70]

The correlation diagram graphically represents the target value (value that is to be influenced) and the control value (value that can be influenced) and shows pairs of values - which may reveal correlations.

shortcut for ‘common specifications’ as defined in the MDR.

[Definition of terms according to MDCG 2019-9 Abbreviations]

CTB is an acronym and stands for "Critical to Business".

CTC is an acronym and stands for "Critical to Customer".

CTQ is an acronym and stands for "Critical to Quality".

'Custom-made device' means any active implantable medical device specifically made in accordance with a medical specialist's written prescription which gives, under his responsibility, specific design characteristics and is intended to be used only for an individual named patient.

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

'Custom-made device' means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. The abovementioned prescription may also be made out by any other person authorized by virtue of his professional qualifications to do so. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user are not considered to be custom-made devices.

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

’Custom-made device’ 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.

[Definition according to (EU) 2017/745 Article 2 No. 3]

2nd party audit, usually conducted by the management representative or a similarly trained person at the customer's or supplier's premises.

Heartbeat of production - indicates the beat at which the customer calls off his goods on average.

The Company-Wide Quality Control; corresponds to today's TQC and is mainly based on the TQM model, but differs from it in its strong employee orientation and the quality tasks distributed throughout the company (decentralisation of quality tasks).

The time that a machine or an employee needs to completely execute its process (e.g. depositing the last good part to depositing the new good part).

The Deutsche Akkreditierungsstelle GmbH is the national accreditation body of the Federal Republic of Germany, based in Berlin. As an independent organization, it assesses, confirms, and monitors the professional competence of laboratories, certification, and inspection bodies. In accordance with Regulation (EC) No. 765/2008 and the Accreditation Body Act (AkkStelleG), it acts in the public interest as the sole service provider for accreditation in Germany.

The German Accreditation Council (DAR) was the umbrella organisation of the German accreditation bodies and was merged into the DAkkS on 01.01.2010.

However, this should not be confused with the Accreditation Council (Foundation for the Accreditation of Study Programmes in Germany). The latter has the legal mandate to ensure the quality of studies and teaching through the accreditation of study programmes.

German Civil Service Association

A decision tree visualises decision rules through the hierarchical, sequential representation of decisions. The consequences in each decision are based on the following situations and help to evaluate decisions and show new starting points for further alternative actions. Note the probability of occurrence to make the decision tree manageable.

William Edwards Deming was an American physicist and statistician whose work earned him the status of a pioneer in quality management. These included the 14 points of a management programme, the Seven Deadly Diseases of a Management System, Deming's Chain Reaction and the Red Bead Experiment.

In Deming's Chain Reaction only hard facts matter. In this case, it is about the costs incurred and not about the corporate image. This method starts with certain basic attitudes:

• a) Everyone is part of the total quality.
• b) Every employee stands for quality in his or her field of activity.
• c) Quality is not only a technique, but also a state of mind.

The chain of reactions has 8 described reactions:

1. Quality improvement, thereby
2. Productivity improvement, thereby
3. Cost reduction in the production of the product, thereby
4. Price reduction, thereby
5. Increase in market share, thereby
6. Securing the position of the company, thereby
7. Securing jobs and ultimately
8. Securing the profit

Derivative means a non-cellular substance extracted from human or animal tissue or cells through a manufacturing process. The final substance used for manufacturing of the device in this case does not contain any cells or tissues.

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

‘Derivative’ means a ‘non-cellular substance’ extracted from human or animal tissue or cells through a manufacturing process. The final substance used for manufacturing of the device in this case does not contain any cells or tissues.

[Definition according to (EU) 2017/745 Article 2 No. 17]

A design FMEA (D-FMEA), also called a construction FMEA (K-FMEA), examines the influences and potential failure modes during the manufacturing and assembly of a product. The method refers in particular to the systematic errors within the design phase.

Means the indirect detection of an agent (present or past exposure). By detecting the presence of surrogate markers, such as antibodies against components of the agent.

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

Means the direct detection of the agent, by detecting

• the presence of the agent itself (e.g. bacterial, viral, fungal, parasitic, protozoal agents), or
• the presence of structural components derived from the agent, such as antigens or nucleic acids.

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

A deviation is at least one non-compliance with a part of requirement for management systems. This deviation raises significant doubts about the ability of the management system - the audited organization - to achieve the intended objectives. As soon as the auditor identifies deviations, they are discussed at the final meeting and a time schedule is set for their resolution.

‘Device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or performance of a device for performance study, including malfunction, use errors or inadequacy in information supplied by the manufacturer.

[Definition according to (EU) 2017/746 Article 2 No. 62]

Any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer.

[Definition of the term according to MDCG 2020-10/1, also corresponds to definition under (EU) 2017/745 Article 2 No. 59]

‘Device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer.

[Definition under (EU) 2017/745 Article 2 No. 59]

‘Device for near-patient testing’ means 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.

[Definition according to (EU) 2017/746 Article 2 No. 6].

‘Device for performance evaluation’ means any device intended by the manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analyses or in other appropriate environments outside his own premises.

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

‘Device for performance study’ means 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.

[Definition according to (EU) 2017/746 Article 2 No. 45].

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.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 45]

‘Device for self-testing’ means any device intended by the manufacturer to be able to be used by lay persons in a home environment.

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

‘Device for self-testing’ means 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.

[Definition according to (EU) 2017/746 Article 2 No. 5].

'Device intended for clinical investigation' means any active implantable medical device intended for use by a specialist doctor when conducting investigations in an adequate human clinical environment.

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

'Device intended for clinical investigation' means any device intended for use by a duly qualified medical practitioner when conducting investigations as referred to in Section 2.1 of Annex X in an adequate human clinical environment. For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorized to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner.

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

'Device used for in vitro diagnosis' means any device which is a reagent, reagent product, kit, instrument, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of samples derived from the human body with a view to providing information on the physiological state, state of health or disease, or congenital abnormality thereof.

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

Are used for the measurement of the analyte (measurand) levels for the purpose of adjusting treatments/interventions as required. Devices for monitoring include the following:

• Devices which are used to assess whether an analyte remains within physiological levels or within an established therapeutic drug range. These types of devices are designed to evaluate an individual’s current state.
• Devices which are used for serial measurement, whereby multiple determinations are taken over time. These types of devices are typically used for the detection/assessment of disease progression/regression, disease recurrence, minimum residual disease, response/resistance to therapy, and/or adverse effects due to therapy. These types of devices are designed to evaluate changes in an individual’s state.

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

Are used to detect the presence of or the predisposition to a disease, disorder or other physiological state in a specimen from an individual, embryo or foetus not demonstrating clinically evident symptoms. Depending on the nature of the condition and the targeted patient population, screening devices may be used routinely or may be restricted to "at risk" patients. This also includes (for example) devices intended to assess the suitability of blood, blood components, cells, tissues or organs, or in any of their derivatives for transfusion, transplantation or cell administration, with respect to transmissible agents.

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

Means 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.

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

Design for Six Sigma.

The German Trade Union Confederation is the largest umbrella organisation of German trade unions.

DGQ is an acronym and stands for Deutsche Gesellschaft für Qualität e.V. (German Society for Quality).

‘Diagnostic sensitivity’ means the ability of a device to identify the presence of a target marker associated with a particular disease or condition.

[Definition according to (EU) 2017/746 Article 2 No. 50]

The ability of a device to identify the presence of a target marker associated with a particular disease or condition.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 50]

’Diagnostic specificity’ means the ability of a device to recognise the absence of a target marker associated with a particular disease or condition.

[Definition according to (EU) 2017/746 Article 2 No. 49].

The ability of a device to recognise the absence of a target marker associated with a particular disease or condition.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 49]

Differentiation generally means the appearance of differences.

The acronym stands for German Chamber of Industry and Commerce.

German Institute for Standardisation or Deutsches Institut für Normung e.V.

DIN standards are standards adopted by the German Institute for Standardisation and are valid throughout Germany.

a natural or legal person making devices available in the Union, other than the manufacturer or the importer.

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

‘Distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.

[Definition under (EU) 2017/745 Article 2 No. 34 also corresponds to definition under (EU) 2017/746 Article 2 No. 27]

Stands for the Six Sigma phase model for the development of products or processes (Define, Measure, Analyse, Design, Verify).

Stands for the standardised Six Sigma phase model

• Define
• Measure
• Analyse
• Improve
• Control

Acronym for German Medical Devices Information and Database System.

Until EUDAMED is fully functional, all medical devices and in vitro diagnostics as well as responsible persons and authorised representatives in Germany should be registered here. This national database belongs to the Federal Institute for Drugs and Medical Devices (BfArM).

Design of Experiment, statistical experimental design.

Defects per million opportunities.

Defects per Unit

German Association for the Certification of Management Systems.

German Gas and Water Association.

‘Economic operator’ means a manufacturer, an authorised representative, an importer or a distributor.

[Definition according to (EU) 2017/746 Article 2 No. 28]

‘Economic operator’ means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3).

[Definition according to (EU) 2017/745 Article 2 No. 35]

Effectiveness is a measure of goal achievement (effectiveness, quality of goal achievement, etc.) and emphasises the operational side of the use of resources.

Control question: "Are the right things being done"?

The effective and efficient implementation of a measure

Efficiency is a measure of cost-effectiveness (cost-benefit reaction) and emphasises the economic side of the use of resources.

Control question: "Are things being done right"?

The EFQM model is a quality management system of total quality management and was developed by the EFQM. This model aims at successful business management (Business Excellence), which enables a holistic view of organisations.

The "eh da costs" are a funny reference to costs that are not taken into account in the calculation, as they are incurred anyway.

The EKUV analysis stands for "Eliminate, Combine, Convert, Simplify" and is an analysis that is used for set-up time optimisation (see also SMED). It is a systematic approach to drastically reduce set-up time.

EMA is the abbreviation for the European Medicines Agency. It is a specialised agency of the European Union for human, veterinary and herbal medicinal products for human use.

An unborn refers to stages in human development after zygote formation. A zygote is considered an embryo in particular from the period of conception to approximately the eighth week, and considered a foetus following this period until birth.
Samples from the embryo or foetus include samples from the embryonic/foetal membranes, fluids and excretions, the umbilical cord, and maternal samples (e.g. blood) containing embryonic/foetal material to be examined.

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

The employee suggestion scheme is part of idea management and is an employee-involving (participative) optimisation system with the aim of using the suggestions and ideas of all employees within an organisation for its benefit.

Employer's Liability Insurance Association (german: Berufsgenossenschaften, BG) are self-governing bodies according to §31 SGB IV. Since 01.01.2011 there have been nine industrial trade associations:

• BG Bau (construction)
• BGHW
• BG ETEM
• VBG
• BG RCI
• BG Verkehr (transport)
• BGN
• BGHM
• BGW

European standards are standards from one of the three European committees

• CEN; Committee for Standardisation
• ETSI; Committee for Telecommunications Standards
• CENELEC; Committee for Electrotechnical Standardisation

EPEI is an acronym for "Every Part Every Interval" and describes a key figure that provides information on whether all products can be manufactured and set up within the desired time interval.

‘Ethics committee’ means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations.

[Definition under (EU) 2017/745 Article 2 No. 56 also corresponds to definition under (EU) 2017/746 Article 2 No. 59]

A European Union reference laboratory designated according to Article 100 of the IVDR.

[Definition according to MDCG 2022-3 No. 3.4]

European Union.

[Definition of terms according to MDCG 2019-9 Abbreviations]

European Databank on Medical Devices

European database on medical devices.

[Definition of term as per MDCG 2021-08 Acronyms, MDCG 2021-28 Acronyms, MDCG 2020-13 Acronyms and MDCG 2019-9 Abbreviations]

Railway and Transport Union.

An external auditor conducts a 3rd party audit. The auditor is an employee of an independent body.

The failure rate provides an objective measure of the reliability of a system by determining the number of failures - related to a specific type of failure and within a defined period of time.

A result where the device incorrectly indicates that the specimen tested negative for the condition, attribute or property under analysis.

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

‘Falsified device’ means 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.

[Definition under (EU) 2017/745 Article 2 No. 9 also corresponds to definition under (EU) 2017/746 Article 2 No. 10]

The fault record card uses attributive tests, i.e. only the number of faulty parts is recorded on the fault record card (no measured values). Thus, only an evaluation of the number of defects can be given.

First-Come First-Served storage method refers to a possible structure within a queue of goods or documents.

FDA is the abbreviation for the US Food and Drug Administration. It controls the safety and efficacy of human and veterinary medicines, biological and medical products, food and radiation-emitting devices. This applies to products produced in the USA as well as imported products.

‘Field safety corrective action’ means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.

[Definition under (EU) 2017/745 Article 2 No. 68 also corresponds to definition under (EU) 2017/746 Article 2 No. 71]

‘Field safety notice’ means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action.

[Definition under (EU) 2017/745 Article 2 No. 69 also corresponds to definition under (EU) 2017/746 Article 2 No. 72]

First In – First Out refers to a possible structure within a queue of goods or documents.

Is a device intended to be used to detect a marker or analyte  and which may be followed by a confirmatory assay. Devices intended to be used solely to monitor a previously determined marker or analyte are not considered first-line assays.

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

FMEA stands for Failure Mode and Effects Analysis. Like FMECA (Failure Mode and Effecty Critical Analysis), FMEA is an analytical method (reliability technique) for identifying potential weaknesses, evaluating them and introducing appropriate measures, as well as evaluating them until they are within the tolerance range.

The formal principle is applied in project management to translate imponderables and risks into calculable processes.

An unborn refers to stages in human development after zygote formation. A zygote is considered an embryo in particular from the period of conception to approximately the eighth week, and considered a foetus following this period until birth.
Samples from the embryo or foetus include samples from the embryonic/foetal membranes, fluids and excretions, the umbilical cord, and maternal samples (e.g. blood) containing embryonic/foetal material to be examined.

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

FPA is an acronym for "First / Internal Party Audit".

First Passed Yield = Rolled Throughput Yield

Shortcut for Field Safety Corrective Action.

[Definition of terms according to MDCG 2019-9 Abbreviations]

Shortcut for Field Safety Notice.

[Definition of terms according to MDCG 2019-9 Abbreviations]

‘Fully refurbishing’, for the purposes of the definition of manufacturer, means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device.

[Definition under (EU) 2017/745 Article 2 No. 31 also corresponds to definition under (EU) 2017/746 Article 2 No. 24]

Measurement capability study

GAMP stands for Good Automated Manufacturing Practice and is the guideline for the validation of computerised systems in the pharmaceutical industry, both for manufacturers and suppliers.

GAP stands for "Good Agricultural Practices" and deals in particular with agricultural land use and animal husbandry. Not to be confused with the GAP audit (measurement of the difference between actual and target values of a quality management system).

A GAP audit or delta audit is a review conducted to determine whether a company meets the regulatory requirements in the medical device industry. It identifies potential gaps where the organisation is not in compliance with the required standards or regulations.

A GAP audit usually consists of the following steps:

• Preliminary meeting to clarify the objectives of the delta audit.
• Process analysis: Consideration of the actual state.
• Comparison of the analysis with the target state, identification of the gap(s)
• Proposing measures for change
• Implementing the measures, concluding the GAP audit in an audit report.

These audits enable those responsible to react to changes before they take effect. In addition, the necessary measures are identified and implemented in a targeted manner.

GCLP stands for "Good Clinical Laboratory Practice" and defines the requirements and rules for testing laboratories for preclinical and clinical studies.

GCP stands for "Good Clinical Practice" and refers to international ethical and scientific aspects and rules for conducting clinical studies.

Police Union, in german: Gewerkschaft der Polizei.

Japanese for "place of action"

Tour to find potential for optimisation.

Japanese for "See for yourself at the scene of the action".

‘Generic device group’ means 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.

[Definition under (EU) 2017/745 Article 2 No. 7 also corresponds to definition under (EU) 2017/746 Article 2 No. 8]

Union for Education and Science.

GLP stands for "Good Laboratory Practice" and defines the organisational procedures and the conditions under which tests are planned, carried out and monitored.

GMP stands for "Good Manufacturing Practice". This refers to guidelines for quality assurance of production processes and their environment - in the production of medicinal products, active ingredients, cosmetics, food and feed.

The GMP requirements are divided into Part 1 and Part 2, along with the corresponding applicable annexes.

GMV is a humorous abbreviation and stands for "common sense".

Gross means the total salary of a value.

Acronym for Good Storage Practice. This forms the guideline for the storage of pharmaceuticals. This regulation applies not only to manufacturers of pharmaceuticals, but also to importers, contract manufacturers and distributors, among others.

Shortcut for General safety and performance requirements.

[Definition of the term according to MDCG 2021-28 Acronyms]

GVP stands for "Good Pharmacovigilance Practice" and deals with the systematic monitoring of the safety of finished medicinal products for human and veterinary use. The aim here is to incidentally detect, assess and understand adverse effects and to initiate the appropriate measures to minimise risk.

GxP refers to all valid guidelines of "good working practice". These guidelines are used in particular in the medical, pharmaceutical and pharmaceutical industry.

The "G" stands for Good and the "P" stands for Practice, the "x" in the middle is replaced by the abbreviation of the corresponding area of validity.

The HACCP principles are the basis for drawing up an appropriate HACCP plan:

1. carry out a hazard analysis.
2. determine the critical points (CCP)
3. define critical limits
4. establish a monitoring system for the critical points
5. define corrective actions if the monitoring system shows that one or more critical point(s) are not under control
6. establish verification procedures to confirm that the HACCP system is operating successfully
7. establish documentation covering all operations and records in accordance with the principles and their application.

Self-reflection - examining one's own approach, processes and behaviour.

Reflection meetings (created through the combination of Hansei and Kaizen).

A hardware FMEA (HW FMEA for short) examines the risks in the field of hardware and electronics.

‘Harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;

[Definition under (EU) 2017/745 Article 2 No. 70 also corresponds to definition under (EU) 2017/746 Article 2 No. 73]

‘Health institution’ means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health;

[Definition under (EU) 2017/745 Article 2 No. 36 also corresponds to definition under (EU) 2017/746 Article 2 No. 29]

This involves smoothing capacity utilisation and levelling out production to minimise the "whip effect" of order fluctuations.

Abbreviation for Highest In - First Out. The goods with the highest value are taken out first. It refers to a possible structure within a queue of goods or documents.

The histogram is a graphical evaluation / visualisation of a distribution function (frequency/time).

Intended for use in the home healthcare environment; intended for use by a lay operator; intended for use with patients who are dependent on mechanical ventilation for their life support. Depending on the intended purpose can be also used in the clinical setting (See e.g. EN ISO 80601-2-72:2015).

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

ICH stands for the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Its core business - bringing together regulatory authorities and the pharmaceutical industry in Europe, Japan and the USA - is to address the scientific and technical aspects of drug registration.

International Electrotechnical Commission

International Food Standard.

Shortcut for Instructions for Use.

[Definition of terms according to MDCG 2020-13 Acronyms and MDCG 2019-9 Abbreviations]

Industriegewerkschaft Bauen-Agrar-Umwelt.

Mining, Chemical and Energy Workers' Union

Workers union for metal.

Chamber of Commerce and Industry

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.

[Definition of term as defined in MDCG 2021-24 No. 3.1.4]

Any device which is intended:

• to be totally introduced into the human body or,
• to replace an epithelial surface or the surface of the eye,

by surgical intervention which is intended to remain in place after the procedure.

Any device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is also considered an implantable device.

[Definition according to (93/42/EEC) Annex IX No. 1.2]

‘Implantable device’ means 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.

[Definition according to (EU) 2017/745 Article 2 No. 5]

a natural or legal person importing devices into the EU from outside the Union.

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

‘Importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market.

[Definition under (EU) 2017/745 Article 2 No. 33 also corresponds to definition under (EU) 2017/746 Article 2 No. 26]

IMS is an abbreviation for an "integrated management system" that results from the combination of at least two or more individual management systems.

‘In vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, 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:

• concerning a physiological or pathological state, or
• concerning a congenital abnormality, or
• to determine the safety and compatibility with potential recipients, or
• to monitor therapeutic measures.

Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.

Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination.

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

‘In vitro diagnostic medical device’ means 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;

(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.

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

‘Incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any harm as a consequence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device.

[Definition according to (EU) 2017/746 Article 2 No. 67]

‘Incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect;

[Definition according to (EU) 2017/745 Article 2 No. 64]

Incoming goods inspection is the inspection of purchased raw materials and semi-finished products according to defined specifications.

refers to the clinical condition that is to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled by the medical device. It should be distinguished from ‘intended purpose/intended use’, which describes the effect of a device. All devices have an intended purpose/intended use, but not all devices have an indication (e.g. medical devices with an intended purpose of disinfection or sterilisation of devices).

[Definition according to MDCG 2020-6 No. 1.2]

refers to the clinical condition that is to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled by the medical device. It should be distinguished from ‘intended purpose/intended use’, which describes the effect of a device. All devices have an intended purpose/intended use, but not all devices have an indication (e.g. medical devices with an intended purpose of disinfection or sterilisation of devices).

[Definition according to MDCG 2020-6 No. 1.2]

Is an agent capable of producing infection. This includes iatrogenic infections, i.e. those infections transmitted during medical treatment and care.

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

Is an agent capable of producing infection. This includes iatrogenic infections, i.e. those infections transmitted during medical treatment and care.

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

‘Informed consent’ means a subject's free and voluntary expression of his or her willingness to participate in a particular performance study, after having been informed of all aspects of the performance study that are relevant to the subject's decision to participate or, in the case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the performance study.

[Definition according to (EU) 2017/746 Article 2 No. 58]

‘Informed consent’ means a subject's free and voluntary expression of his or her willingness to participate in a particular clinical investigation, after having been informed of all aspects of the clinical investigation that are relevant to the subject's decision to participate or, in the case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the clinical investigation.

[Definition according to (EU) 2017/745 Article 2 No. 55]

An area of skin or a mucous membrane presenting a pathological change or change following disease, a wound or a scar.

[Definition of term as defined in MDCG 2021-24 No. 3.1.4]

‘Injured skin or mucous membrane’ means an area of skin or a mucous membrane presenting a pathological change or change following disease or a wound.

[Definition according to (EU) 2017/745 Annex VIII Chapter I No. 2.8]

’Instructions for use’ means the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken.

[Definition under (EU) 2017/745 Article 2 No. 14 also corresponds to definition under (EU) 2017/746 Article 2 No. 14]

Means equipment or apparatus intended by a manufacturer to be used as an IVD medical device.

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

'Intended purpose' means the use for which the medical device is intended and for which it is suited according to the data supplied by the manufacturer in the instructions.

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

‘Intended purpose’ means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions for use and/or in promotional materials.

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

‘Intended purpose’ means 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 or as specified by the manufacturer in the performance evaluation.

[Definition according to (EU) 2017/746 Article 2 No. 12]

'Intended purpose' means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials.

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

‘Intended purpose’ means 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.

[Definition according to (EU) 2017/745 Article 2 No. 12]

The MDR defines ‘intended purpose’, but not ‘intended use’. ‘Intended use’ should be considered to have the same meaning as ‘intended purpose’.

[Definition according to MDCG 2020-6 No. 1.2]

1st party audit. The auditor is an employee of the same organization in which the audit is performed.

An internal auditor conducts a 1st party audit. The auditor is an employee of the same organization in which the audit is performed.

‘Interoperability’ is the ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to:

(a) exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data, and/or

(b) communicate with each other, and/or

(c) work together as intended.

[Definition under (EU) 2017/745 Article 2 No. 26 also corresponds to definition under (EU) 2017/746 Article 2 No. 19]

With the help of the interrelationship diagram, complex interrelationships can be represented more simply, but also integrated in networks. These serve the general planning of projects / interrelationships. With this representation it is quite easy to show the actual core and support processes and their interactions.

‘Interventional clinical performance study’ means a clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment.

[Definition according to (EU) 2017/746 Article 2 No. 46].

Any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body. A device that administers energy to the body should not be considered as invasive if only energy it emits penetrates the body and not the device itself.

[Definition of term as defined in MDCG 2021-24 No. 3.1.4]

‘Invasive device’ means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.

[Definition according to (EU) 2017/745 Article 2 No. 6]

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

[Definition according to (93/42/EEC) Annex IX No. 1.2]

A device that is assessed in a clinical investigation.

Note: An investigational device can be a non-CE marked device or a CE marked device. The definition in MDR Article 2(46) does not differentiate between different regulatory statuses of devices. However, the reporting requirements are different depending on whether the clinical investigation is done for purposes described in Article 62, 74 or 82. The definition is understood to cover also the devices investigated in PMCF investigations, even if they are not subject to notification per Art 74.1.

[Definition of the term according to MDCG 2020-10/1, also corresponds to definition under (EU) 2017/746 Article 2 No. 46]

‘Investigational device’ means a device that is assessed in a clinical investigation.

[Definition according to (EU) 2017/745 Article 2 No. 46]

‘Investigator’ means an individual responsible for the conduct of a performance study at a performance study site.

[Definition according to (EU) 2017/746 Article 2 No. 48]

An individual responsible for the conduct of a performance study at a performance study site.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 48]

‘Investigator’ means an individual responsible for the conduct of a clinical investigation at a clinical investigation site.

[Definition according to (EU) 2017/745 Article 2 No. 54]

Input-Process-Output diagram

The International Register of Certificated Auditors is an auditor certification body that maintains a pool of qualified, certified and independent auditors.

The Ishikawa diagram is one of the best-known tools for identifying the cause of an error in a categorised way. In the meantime, Ishikawa uses the 7Ms (man, machine, method, material, measurement, environment, management) and takes into account their contributions to the problem.

International Organization for Standardization

International Telecommunications Union

In vitro diagnostic medical device, a medical device intended by the manufacturer for the in vitro examination of specimens derived from the human body for a medical purpose.

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

EU In Vitro Diagnostic Medical Devices Regulation: (EU) 2017/746.

On 26 May 2017, this EU regulation became binding in all EU member states and replaces the currently valid EU directive within the transition period of five years. The IVDD (98/79/EC) was replaced by the IVDR (2017/746 EU) on 26 May 2022.

Autonomous quality assurance with zero-defect principle - do not produce, pass on or accept anything bad.

JIPM is an abbreviation for the "Japan Institute of Plant Maintenance".

Just-in-Sequence is the further development of JIT and refers not only to just-in-time delivery, but also to the correct sequence.

Just-in-time (JIT) means production and delivery tailored to customer needs. Today, it refers to the entire life cycle of a product - from on-time development to delivery to the customer.

A regular meeting at the same place and time to share information and discuss the status quo.

Japanese for "radical change".

KAIZEN consists of the Japanese symbol KAI "change" and the symbol ZEN "good" and stands for change for the better. KAIZEN is a synonym for continuous improvement in small steps and is in principle a permanent interpretation of the PDCA cycle.

KAIZEN uses the Seven Tools Q7 for improvement work.

The Kaizen Blitz describes the recording (documenting) of discovered problems or weak points within the process in Gemba-Walk, or the LIA.

Hidden under the KAIZEN umbrella are various tools, methods and management systems which can improve the process through "small steady steps".

Signal, card (Japanese) - serves as a simple order form and for production control by passing on information in regulated kanban circuits.

The Kano model describes a visual matrix that represents delighters, satisfiers and dissatisfiers in relation to the CTQ's of a product in a Cartesian coordinate system, with customer satisfaction on the ordinate and the degree of fulfilment on the abscissa.

Japanese for "meeting emotional customer needs / achieving customer enthusiasm" (compare Kano model).

A distinction is made between "strategic" and "operational" key performance indicators. These key indicators serve the continuous control of processes and the early detection of deviations and changes.

•     Strategic key indicators control effectiveness, e.g. profit, sales growth, profitability,...
•     Operational key indicators control efficiency (process key figures), e.g. throughput times, utilisation rates,...

Konzern In - First Out; consumption sequence procedure mainly occurring in accounting.

Konzern In - Last Out; consumption sequence procedure mainly occurring in accounting.

KISS is a very well-known acronym that can have different meanings. The most common meaning is Keep It Short and Simple.

‘Kit’ means 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.

[Definition according to (EU) 2017/746 Article 2 No. 11].

Key performance indicators

Key Process Input Variable.

Key Process Output Variable.

Informal partnership with suppliers based on the 6Rs (part of corporate governance).

’Label’ means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices.

[Definition under (EU) 2017/745 Article 2 No. 13 also corresponds to definition under (EU) 2017/746 Article 2 No. 13]

‘Lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline;

[Definition under (EU) 2017/745 Article 2 No. 38 also corresponds to definition under (EU) 2017/746 Article 2 No. 31]

Term from the MIT study in 1990 (second industrial revolution).

It is a corporate philosophy that is intended to increase the competitiveness of the organisation within the framework of a holistic approach.

Initial analysis (also potential analysis), which often uses LEAN accounting or a value stream to identify the possible need for process optimisation.

Lean management is a philosophy based on 6 basic strategies:

• continuous material flow
• simultaneous engineering
• strategic use of capital
• Company as a family
• proactive marketing
• comprehensive quality management

• low inventories
• Reduction of inventory and factory space
• Optimisation in the use of human resources
•  Reduction of rejects and defects
• Time reduction in product development, with an increase in product variety

‘Legacy devices’: this is considered to include all devices previously CE marked under the European Medical Devices Directive 93/42/EEC (MDD) or Active Implantable Medical Devices Directive 90/385/EEC (AIMDD).

[Definition according to MDCG 2020-6 No. 1.2]

This guidance follows the approach set out in Guidance MDCG 2019-52 according to which ‘legacy devices’ should be understood as devices, which, in accordance with Article 120(3) MDR and Article 110(3) IVDR, are placed on the market after MDR or IVDR dates of application respectively and until 26 May 2024, or until the relevant certificate becomes void, if certain conditions are fulfilled.

• devices which are class I devices under Directive 93/42/EEC, for which a declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body;
• devices covered by a valid certificate issued in accordance with Directives 90/385/EEC or 93/42/EEC prior to 26 May 2021;
• devices covered by a valid certificate issued in accordance with Directive 98/79/EC prior to 26 May 2022.

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

A legal compliance audit is a review of whether all laws, regulations and notices affecting the company are being complied with.

‘Level of clinical evidence’: this terminology is used in the MDR with respect to requirements for demonstration of conformity with the relevant GSPR and overall benefit-risk. It is understood to encompass the amount and quality of evidence (i.e. its characterisation by quality, quantity, completeness and statistical validity, etc.) required to demonstrate safety, performance and the benefit-risk conclusion of a medical device. It should not be confused with the term ‘levels of evidence’ (as used in evidence-based medicine) which is used to rank study designs, and is only a part of the concept ‘level of clinical evidence’. Regarding the assessment of the level of clinical evidence for the device in question, see sections 6.3 and 6.5d of this document.

[Definition according to MDCG 2020-6 No. 1.2]

Shortcut for Lean Initial Audit

Are diseases, conditions or situations that in general result in death. These are often untreatable, treatment options are limited or require major medical interventions.

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

Last In - First Out;  denotes a possible structure within a queue of goods or documents.

‘Likelihood ratio’ means the likelihood of a given result arising in an individual with the target clinical condition or physiological state compared to the likelihood of the same result arising in an individual without that clinical condition or physiological state.

[Definition according to (EU) 2017/746 Article 2 No. 54].

Likelihood of a given result arising in an individual with the target clinical condition or physiological state compared to the likelihood of the same result arising in an individual without that clinical condition or physiological state.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 54]

The ability to provide measured quantity values that are directly proportional to the value of the measurand in the sample.
Source: ISO 18113-1

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

Food Hygiene Regulation; in German: Lebensmittelhygiene-Verordnung.

The condition by which substances remain in a specific site without being distributed into the body via the blood and/or lymphatic system.

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

Lowest In - First Out; the item with the highest value is taken out first - refers to a possible structure within a queue of goods or documents.

Normally intended for continuous use for more than 30 days.

[Definition of term as defined in MDCG 2021-24 No. 3.1.2]

Normally intended for continuous use for more than 30 days.

[Definition according to (93/42/EEC) Annex IX No. 1.1]

‘Long term’ means normally intended for continuous use for more than 30 days.

[Definition according to (EU) 2017/745 Annex VIII Chapter I No. 1.3]

Named after its discoverer, the US statistician and economist Max Otto Lorenz. It graphically represents the inequality of statistical distribution.

‘Making available on the market’ means any supply of a device, other than a device for performance study, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.

[Definition according to (EU) 2017/746 Article 2 No. 20]

‘Making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.

[Definition according to (EU) 2017/745 Article 2 No. 27]

Management processes include all processes for leading and controlling the company (e.g. policy, goals, programmes, delegation, auditing, internal communication, etc.).

The management representative (formerly also BdOL: Superior Performance Officer) is the appointed officer or a staff position within an organisation and reports to the management and its internal service providers and advisors for the respective management system.

The new seven management tools "M7" (or also called "N7") are composed of the following methods:

• Affinity diagram
• Interrelationship diagram
• Tree diagram
• Matrix diagram
• Portfolio
• Network diagram
• Decision tree

natural or legal person responsible for the production, packaging and labelling of the device before it is placed on the market in their own name.

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

‘Manufacturer’ means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.

The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as devices with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient.

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

'Manufacturer' means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party. The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient.

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

‘Manufacturer’ means 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 trademark.

[Definition under (EU) 2017/745 Article 2 No. 30 also corresponds to definition under (EU) 2017/746 Article 2 No. 23]

Association of Salaried and Civil Servant Doctors in Germany.

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]
 

‘Market surveillance’ means the activities carried out and measures taken by public authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection.

[Definition according to (EU) 2017/746 Article 2 No. 64]

‘Market surveillance’ means the activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection.

[Definition according to (EU) 2017/745 Article 2 No. 61]

Within a matrix diagram, relationships and interactions of two different groups of characteristics are represented and evaluated.

Most Advanced Yet Acceptable - as complex as just acceptable.

Management by Facts.

Shortcut for Medical Device Coordination Group.

[Definition of the term according to MDCG 2021-6 Abbreviations]

Shortcut for Medical Device Regulation, referring to Regulation (EU) 2017/745 on medical devices.

[Definition of terms as per MDCG 2021-6 Abbreviations, MDCG 2020-13 Acronyms and MDCG 2019-9 Abbreviations]

Short for Medical Device Single Audit Program

The MDSAP is a program for simplified audits and easier access to the markets of participating countries. However, national regulations take precedence. Participating countries are the U.S., Japan, Canada, Brazil and Australia. Argentina, South Korea and Singapore are listed as affiliate members. Observers are the EU, the UK and the WHO.

Shortcut for Medical Device Software. 

[Definition according to MDCG 2021]

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]
 

The measurements made by devices with a measuring function shall be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC.

[Definition according to (EU) 2017/745 Article 1, Chapter 2, point 15.2. no. 39]

A set of values of quantities of the same kind that can be measured by a given measuring instrument or measuring system with specified instrumental measurement uncertainty, under defined conditions
Source: International vocabulary of metrology – Basic and general concepts and associated terms (VIM) 3rd edition

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

MedDRA is a medical dictionary for proper activities and is operated by ICH.

'Medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be used for human beings in the:

• diagnosis, prevention, monitoring, treatment or alleviation of disease or injury,
• investigation, replacement or modification of the anatomy or of a physiological process,
• control of conception, and which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means, but which may be assisted in its function by such means.

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

‘Medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap,
• investigation, replacement or modification of the anatomy or of a physiological process,
• control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

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

'Medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
• investigation, replacement or modification of the anatomy or of a physiological process,
• control of. conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

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

‘Medical device’ means 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.

[Definition under (EU) 2017/745 Article 2 No. 1 also corresponds to definition under (EU) 2017/746 Article 2 No. 1]

Medical devices using prestored gases and/or vacuum as a power source are regarded as active devices, as long as they fulfil both the criteria under the definition e.g. gas mixers with anaesthesia machines, aerosol pain relief sprays with a pre-stored propellant gas supply and gas-powered suction pumps.

Heating/cooling pads intended only to release stored thermal energy are not active devices because they do not act by conversion of energy. However, heating/cooling pads which act by chemical action (e.g. exothermic or endothermic reaction) are active devices as they are converting chemical energy into heat and/or vice versa.

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

According to the definition given in Directive 2001/83/EC:
‘(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.’

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

All active substances and combinations of active substances intended for medical diagnosis, therapy or prophylaxis, or which influence physiological functions. The term goes beyond that of medication, as it also includes contrast media and the like.

According to the definition given in Directive 2001/83/EC:
‘(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.’

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

Property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty. The metrological traceability chain is a sequence of measurement standards and calibrations that is used to relate a measurement result to a reference. Source: International vocabulary of metrology – Basic and general concepts and associated terms (VIM) 3rd edition

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

This is the term used to describe interim goals in project management.

According to the British mental trainer Tony Buzan, a method that branches out from the starting point further and further into individual ideas and tasks. Individual topics can be identified by different colour codes.

Minitab is a statistical software whose field of application is strongly influenced by Six Sigma.

MINT is a acronym for mathematics, computer science, natural science and technology; in german: Mathematik, Informatik, Naturwissenschaft und Technik.

MS is an abbreviation for a management system.

Shortcut for Member State.

[Definition of the term according to MDCG 2021-6 Abbreviations]

Measurement system analysis.

Mean time before failure, average life span.

Mean time to failure, average life span for non-repairable parts, e.g. flash lamps.

A ‘nanomaterial’ means 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 according to MDR, Article 2(18). Related definitions on ‘particle’, ‘agglomerate’ and ‘aggregate’ are also included in the MDR Article 2(19-21). The definitions on nanomaterial and the related terms were taken from Commission Recommendation 2011/696/EU on the definition of nanomaterials23. Guidance on terms and concepts used in the definition can be found in a report from the European Commission’s Joint Research Centre.

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

‘Nanomaterial’ means 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.

[Definition according to (EU) 2017/745 Article 2 No. 18]

Shortcut for Notified Body.

[Definition of terms according to MDCG 2019-9 Abbreviations]

Shortcut for National Competent Authority.

[Definition of term as per MDCG 2021-08 Acronyms and MDCG 2021-28 Acronyms]

Net Equipment Effectiveness (NEE) = Net Total Equipment Effectiveness (NGE).
Formula: NEE = Performance*Quality
Compare with OEE and TEEP.

‘Negative predictive value’ means the ability of a device to separate true negative results from false negative results for a given attribute in a given population.

[Definition according to (EU) 2017/746 Article 2 No. 53].

The ability of a device to separate true negative results from false negative results for a given attribute in a given population.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 53]

Net means a value minus all "added" values (e.g. tare, taxes, etc.).

Ex: Gross weight - tare weight = net weight.

With the help of a network diagram, logical connections can be shown and thus enable the determination of critical points/processes.

A newborn, or neonate, refers to an infant in the first 28 days after birth.

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

Food and Catering Union.

‘Non-viable’ means having no potential for metabolism or multiplication.

[Definition according to (EU) 2017/745 Article 2 No. 16]

an organisation that issues certificates to manufacturers, demonstrating that the manufacturer has fulfilled certain legal requirements.

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

’Notified body’ means a conformity assessment body designated in accordance with this Regulation.

[Definition under (EU) 2017/745 Article 2 No. 42 also corresponds to definition under (EU) 2017/746 Article 2 No. 34]

Overall Administration Effectiveness.

Formula: OAE = OEE*OSE

A observation is at least one non-compliance with a part of a management system requirement. An observation is not in itself a situation that causes significant doubt about the ability of the audited organisation's management system to achieve its intended objectives.

Overall Equipment Effectiveness (OEE).
Formula: OEE = Availability*Performance*Quality

Original Equipment Manufacturer.

Is the result of conception, at all stages of development, embryo and foetus, premature and full term neonates, child and adult.

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

Devices placed on the market according to the medical devices Directives or the in vitro diagnostic medical devices Directive before the date of application of the MDR and IVDR or placed on the market before the Directives entered into force.

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

Manufacturing concept WITHOUT WIP: the product is passed individually from one workstation to the next to save resources.

Operational indicators monitor efficiency (process indicators), e.g. throughput times, utilisation rates,...

The ordinate is the vertical orientation of a coordinate system.

Mnemonic: "The ordinate goes up and the abscissa goes the other way".

Overall Service Effectiveness

Outgoing goods inspection is the inspection of the finished and semi-finished products according to the defined specification.

Bottleneck process that stops production altogether or sets the maximum flow.

Pareto analysis separates the "important" from the "less important" causes of problems. It thus presents the causes of problems in order of the importance of their effect.

The Pareto principle - also known as the "80-20 rule" - states that often problems can be solved with 20% to 80% of the resources, or that 80% of the resources must be used to solve the remaining 20%.

‘Particle’, for the purposes of the definition of nanomaterial in point (18), means a minute piece of matter with defined physical boundaries.

[Definition according to (EU) 2017/745 Article 2 No. 19]

PDCA stands for Plan, Do, Check, Act, formerly also PDSA (Plan, Do, Study, Action) and is number 5 of the 14 points of the management programme according to Deming. In Germany, PDCA stands for continuous planning, implementation, control and correction, or improvement of the management programme. More precisely, "P" stands for the planning of the improvement, "D" for the execution of the improvement measure, "C" for the review of the effectiveness and "A" for the implementation, standardisation or adaptation.

The PDCA scheme is carried out in four steps:

1. Problem analysis
2. Solution finding
3. Review
4. Implementation

A performance audit deals with the conformity related to the objective and systematic review of the set goals, their achievement (effectiveness) in relation to the resources used to achieve the goals - or whether these were used economically and efficiently.

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

[Definition according to (EU) 2017/746 Article 2 No. 44].

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

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 44]

‘Performance of a device’ means the ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting that intended purpose.

[Definition according to (EU) 2017/746 Article 2 No. 39].

Performance of a device means the ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting that intended purpose.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 39]

‘Performance study plan’ means a document that describes the rationale, objectives, design methodology, monitoring, statistical considerations, organisation and conduct of a performance study.

[Definition according to (EU) 2017/746 Article 2 No. 43].