Glossary
Selected key terms pertaining to medical device development are listed below with References.
Key Terms
There are currently 43 key terms in this directory beginning with the letter C.
CE marking
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
[EU MDR 2017/745, EU IVDR 2017/746]
change control
assessment and determination of the appropriateness of a proposed alteration to product, process, or equipment
[ISO 11139:2018]
class
one of the three categories of regulatory control for medical devices, defined below:
(1) Class I means the class of devices that are subject to only the general controls authorized by or under sections 501 (adulteration), 502 (misbranding), 510 (registration), 516 (banned devices), 518 (notification and other remedies), 519 (records and reports), and 520 (general provisions) of the act. A device is in class I if (i) general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, or (ii) there is insufficient information from which to determine that general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but the device is not life-supporting or life-sustaining or for a use which is of substanial importance in preventing impairment of human health, and which does not present a potential unreasonable risk of illness of injury.
(2) Class II means the class of devices that is or eventually will be subject to special controls. A device is in class II if general controls alone are insufficient to provide reasonable assurance of its safety and effectiveness and there is sufficient information to establish special controls, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidance documents (including guidance on the submission of clinical data in premarket notification submissions in accordance with section 510(k) of the act), recommendations, and other appropriate actions as the Commissioner deems necessary to provide such assurance. For a device that is purported or represented to be for use in supporting or sustaining human life, the Commissioner shall examine and identify the special controls, if any, that are necessary to provide adequate assurance of safety and effectiveness and describe how such controls provide such assurance.
(3) Class III means the class of devices for which premarket approval is or will be required in accordance with section 515 of the act. A device is in class III if insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness or that application of special controls described in paragraph (c)(2) of this section would provide such assurance and if, in addition, the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury.
(1) Class I means the class of devices that are subject to only the general controls authorized by or under sections 501 (adulteration), 502 (misbranding), 510 (registration), 516 (banned devices), 518 (notification and other remedies), 519 (records and reports), and 520 (general provisions) of the act. A device is in class I if (i) general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, or (ii) there is insufficient information from which to determine that general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but the device is not life-supporting or life-sustaining or for a use which is of substanial importance in preventing impairment of human health, and which does not present a potential unreasonable risk of illness of injury.
(2) Class II means the class of devices that is or eventually will be subject to special controls. A device is in class II if general controls alone are insufficient to provide reasonable assurance of its safety and effectiveness and there is sufficient information to establish special controls, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidance documents (including guidance on the submission of clinical data in premarket notification submissions in accordance with section 510(k) of the act), recommendations, and other appropriate actions as the Commissioner deems necessary to provide such assurance. For a device that is purported or represented to be for use in supporting or sustaining human life, the Commissioner shall examine and identify the special controls, if any, that are necessary to provide adequate assurance of safety and effectiveness and describe how such controls provide such assurance.
(3) Class III means the class of devices for which premarket approval is or will be required in accordance with section 515 of the act. A device is in class III if insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness or that application of special controls described in paragraph (c)(2) of this section would provide such assurance and if, in addition, the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury.
[FDA 21CFR860]
classification name
the term used by the Food and Drug Administration and its classification panels to describe a device or class of devices for purposes of classifying devices under section 513 of the act
[FDA 21CFR807]
cleaning
physical removal of soil and contaminants from an item to the extent necessary for further processing or for the intended use
[FDA guidance: Reprocessing Medical Devices...(2017)]
cleaning
removal of contaminants to the extent necessary for further processing or for intended use
[ISO 11139:2018]
clinical benefit
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
[EU MDR 2017/745]
clinical benefit
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
[EU IVDR 2017/746]
clinical data
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
— 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
[EU MDR 2017/745]
clinical evaluation
assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer
[ISO 13485:2016]
clinical evaluation
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
[EU MDR 2017/745]
clinical evidence
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
[EU MDR 2017/745]
clinical evidence
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
[EU IVDR 2017/746]
clinical investigation
any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device
[EU MDR 2017/745]
clinical investigation (clinical research, clinical study)
any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58, regarding nonclinical laboratory studies.
Note: The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for purposes of this part.
[FDA 21CFR50, FDA 21CFR56]
Note: The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for purposes of this part.
[FDA 21CFR56]
clinical investigation (clinical study, clinical trial)
systematic investigation in one or more human subjects, undertaken to assess the clinical performance, effectiveness or safety of a medical device
Note: For the purpose of this document, “clinical trial” or “clinical study” are synonymous with “clinical investigation”.
Note: For the purpose of this document, “clinical trial” or “clinical study” are synonymous with “clinical investigation”.
[ISO 14155:2020]
clinical performance
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
[EU MDR 2017/745]
clinical performance
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
[EU IVDR 2017/746]
clinical performance
behaviour of a medical device and response of the subject(s) to that medical device in relation to its intended use, when correctly applied to appropriate subject(s)
Note: Clinical performance can be defined under national regulations.
Note: Clinical performance can be defined under national regulations.
[ISO 14155:2020]
clinical performance of an IVD medical device
ability of an IVD medical device to yield results that are correlated with a particular clinical condition or physiological/pathological process/state in accordance with the intended use (clinical test purpose, target population and intended user)
Note: In accordance with intended use, clinical performance can include expected values, diagnostic sensitivity and diagnostic specificity based on the known clinical condition or physiological/pathological process/state of the individual, and negative and positive predictive values based on the prevalence of the disease.
Note: In accordance with intended use, clinical performance can include expected values, diagnostic sensitivity and diagnostic specificity based on the known clinical condition or physiological/pathological process/state of the individual, and negative and positive predictive values based on the prevalence of the disease.
[ISO 20916:2019]
clinical performance study
study undertaken to establish or confirm the clinical performance of an IVD medical device
[ISO 20916:2019]
combination product
includes:
(1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
(2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;
(3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or
(4) Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.
Note 1: "Co-packaged combination product" has the meaning set forth in §3.2(e)(2) of this chapter.
Note 2: "Single-entity combination product" has the meaning set forth in §3.2(e)(1) of this chapter.
(1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
(2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;
(3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or
(4) Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.
[FDA 21CFR3]
Note 1: "Co-packaged combination product" has the meaning set forth in §3.2(e)(2) of this chapter.
Note 2: "Single-entity combination product" has the meaning set forth in §3.2(e)(1) of this chapter.
[FDA 21CFR4]
combination product
entity presented as a single health care product that physically, chemically, or otherwise brings together or mixes items regulated under separate legislation
[ISO 11139:2018]
commercial distribution
any distribution of a device intended for human use which is held or offered for sale but does not include the following:
(1) Internal or interplant transfer of a device between establishments within the same parent, subsidiary, and/or affiliate company;
(2) Any distribution of a device intended for human use which has in effect an approved exemption for investigational use under section 520(g) of the act and part 812 of this chapter;
(3) Any distribution of a device, before the effective date of part 812 of this chapter, that was not introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, and that is classified into class III under section 513(f) of the act: Provided, That the device is intended solely for investigational use, and under section 501(f)(2)(A) of the act the device is not required to have an approved premarket approval application as provided in section 515 of the act; or
(4) For foreign establishments, the distribution of any device that is neither imported nor offered for import into the United States.
(1) Internal or interplant transfer of a device between establishments within the same parent, subsidiary, and/or affiliate company;
(2) Any distribution of a device intended for human use which has in effect an approved exemption for investigational use under section 520(g) of the act and part 812 of this chapter;
(3) Any distribution of a device, before the effective date of part 812 of this chapter, that was not introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, and that is classified into class III under section 513(f) of the act: Provided, That the device is intended solely for investigational use, and under section 501(f)(2)(A) of the act the device is not required to have an approved premarket approval application as provided in section 515 of the act; or
(4) For foreign establishments, the distribution of any device that is neither imported nor offered for import into the United States.
[FDA 21CFR807]
complaint
written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization's control or related to a service that affects the performance of such medical devices
[ISO 13485:2016]
complaint
any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution
[FDA 21CFR820]
component
any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.
[FDA 21CFR820]
conformity assessment
the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled
[EU MDR 2017/745, EU IVDR 2017/746]
conformity assessment body
a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection
[EU MDR 2017/745, EU IVDR 2017/746]
contract manufacturer
[supplier that] manufactures a finished device to another establishment's specifications
Note: Includes contract packagers
Note: Includes contract packagers
[FDA website: Who Must Register...]
contract sterilizer
[supplier that] provides a sterilization service for another establishment's devices
[FDA website: Who Must Register...]
copyright
a form of protection provided to the authors of "original works of authorship" including literary, dramatic, musical, artistic, and certain other intellectual works, both published and unpublished.
Note: The 1976 Copyright Act generally gives the owner of copyright the exclusive right to reproduce the copyrighted work, to prepare derivative works, to distribute copies or phonorecords of the copyrighted work, to perform the copyrighted work publicly, or to display the copyrighted work publicly.
Note: The 1976 Copyright Act generally gives the owner of copyright the exclusive right to reproduce the copyrighted work, to prepare derivative works, to distribute copies or phonorecords of the copyrighted work, to perform the copyrighted work publicly, or to display the copyrighted work publicly.
[USPTO]
correct use
normal use without use error
Note 1: Deviation from instructions for use is only considered use error if it leads to a medical device response that is different than intended by the manufacturer or expected by the user.
Note 2: The figure below shows the relationships of the types of use.
Note 1: Deviation from instructions for use is only considered use error if it leads to a medical device response that is different than intended by the manufacturer or expected by the user.
Note 2: The figure below shows the relationships of the types of use.
[IEC 62366-1:2015]
corrective action
action to eliminate the cause of a nonconformity and to prevent recurrence
[ISO 9000:2015]
corrective action
action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation
[EU MDR 2017/745, EU IVDR 2017/746]
corrective and preventive action (CAPA)
The purpose of the corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence. Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documenting these activities are essential in dealing effectively with product and quality problems, preventing their recurrence, and preventing or minimizing device failures.
[FDA website: Guide to Inspections of Quality Systems]
custom device
a device within the meaning of section 520(b) of the Federal Food, Drug, and Cosmetic Act
[FDA 21CFR812]
custom-made device
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
Note: 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
Note: 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
[EU MDR 2017/745]
customer
person or organization that could or does receive a product or a service that is intended for or required by this person or organization
Example: Consumer, client, end-user, retailer, receiver of product or service from an internal process, beneficiary and purchaser.
Note: A customer can be internal or external to the organization.
Example: Consumer, client, end-user, retailer, receiver of product or service from an internal process, beneficiary and purchaser.
Note: A customer can be internal or external to the organization.
[ISO 9000:2015]
customer satisfaction
customer’s perception of the degree to which the customer’s expectations have been fulfilled
Note 1: It can be that the customer’s expectation is not known to the organization, or even to the customer in question, until the product or service is delivered. It can be necessary for achieving high customer satisfaction to fulfil an expectation of a customer even if it is neither stated nor generally implied or obligatory.
Note 2: Complaints are a common indicator of low customer satisfaction but their absence does not necessarily imply high customer satisfaction.
Note 3: Even when customer requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction.
Note 1: It can be that the customer’s expectation is not known to the organization, or even to the customer in question, until the product or service is delivered. It can be necessary for achieving high customer satisfaction to fulfil an expectation of a customer even if it is neither stated nor generally implied or obligatory.
Note 2: Complaints are a common indicator of low customer satisfaction but their absence does not necessarily imply high customer satisfaction.
Note 3: Even when customer requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction.
[ISO 9000:2015]
Medical device developers are strongly encouraged to consult the listed reference for each key term to fully understand the context behind the definition and its intended application.
Definitions from the FDA Code of Federal Regulation (CFR) are listed without dates and are accurate through December 2020. Consult the listed FDA reference (online) to confirm the latest definition.