Our glossary for guidance - Letter C

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).