Our glossary for guidance - Letter D

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.