Medical Device Glossary

The medical device glossary presents definitions and abbreviations common in the world of medical device regulations. They are collected from MDR, IVDR, harmonised standards, MDCG guidelines and other important medical device documents. Is an important definition missing? Don’t hesitate to contact us.

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

A

abnormal use

IEC 62366-1:2015

conscious, intentional act or intentional omission of an act that is counter to or violates normal use and is also beyond any further reasonable means of user interface-related risk control by the manufacturer

EXAMPLE: Reckless use or sabotage or intentional disregard of information for safety are such acts.

NOTE 1: See also 4.1.3 of IEC 62366-1:2015.

NOTE 2: An intended but erroneous action that is not abnormal use is considered a type of use error.

NOTE 3: Abnormal use does not relieve the manufacturer from considering non-user interface-related means of risk control.

accessory

ISO 20417:2021

item, intended specifically by its manufacturer, to be used together with one or more medical devices to specifically enable or assist those medical devices to be used in accordance with their intended use

NOTE 1: An accessory is typically a consumable or separate item for use with one or more medical devices.

NOTE 2: Some authorities having jurisdiction consider an accessory to be a medical device.

NOTE 3: Some authorities having jurisdiction have a different definition of accessory.

accessory for a medical device

MDR

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)

accessory for an in vitro diagnostic medical device

IVDR

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);

accompanying documentation

ISO 14971:2019, EN ISO 15223:2021, IEC 62366-1:2015

materials accompanying a medical device and containing information for the user or those accountable for the installation, use, maintenance, decommissioning and disposal of the medical device, particularly regarding safe use

NOTE 1: The accompanying information shall be regarded as part of the medical device or accessory.

NOTE 2: Accompanying documentation is not necessarily a written or printed document but could involve auditory, visual, or tactile materials and multiple media types.

NOTE 3: Medical devices that can be used safely without instructions for use are exempted from having instructions for use by some authorities with jurisdiction.

accompanying information

ISO 20417:2021, EN ISO 15223-1:2021

information accompanying or marked on a medical device or accessory for the user or those accountable for the installation, use, processing, maintenance, decommissioning and disposal of the medical device or accessory, particularly regarding safe use

NOTE 1: The accompanying information shall be regarded as part of the medical device or accessory.

NOTE 2: The accompanying information can consist of the label, marking, instructions for use, technical description, installation manual, quick reference guide, etc.

NOTE 3: Accompanying information is not necessarily a written or printed document but could involve auditory, visual, or tactile materials and multiple media types (e.g., CD/DVD-ROM, USB stick, website).

NOTE 4: see figure 1 in EN ISO 15223-1:2021

NOTE 5: The label can include the information on the packaging of the medical device.

NOTE 6: e-documentation can  include any or all types of information supplied by the manufacturer partially or entirely.

NOTE 7: Marketing information is also known as promotional material.

NOTE 8: There is guidance or rationale related to accompanying information in ISO 20417:2021 Annex A.

active device

SOURCE: MDR

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.

ADME

SOURCE: unkown

absorption, distribution, metabolism and excretion of a substance by a body

adverse event

SOURCE: IVDR

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

SOURCE: MDR

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

advisory notice

SOURCE: EN ISO 13485:2016

notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary information or to advise on action to be taken in the:

  • use of a medical device,
  • modification of a medical device,
  • return of the medical device to the organization that supplied it, or
  • destruction of a medical device

NOTE: Issuance of an advisory notice can be required to comply with applicable regulatory requirements.

agglomerate

SOURCE: MDR

for the purposes of the definition of nanomaterial, 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

aggregate

SOURCE: MDR

for the purposes of the definition of nanomaterial, means a particle comprising of strongly bound or fused particles

allowable limit (AL)

SOURCE: ISO 10993-17:2009

largest amount of a leachable substance that is deemed acceptable on a daily basis, when taken into the body through exposure to a medical device

NOTE: Allowable limits are expressed in dose to the patient for each applicable exposure period. The units used are mass per unit time, e.g. milligrams per day. These doses represent tolerable risks for medical devices under the circumstances of intended use.

analytical performance

SOURCE: IVDR

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

analytical sensitivity

SOURCE: MDCG 2022-2 (IVD) 

The capability of the method to distinguish between two close concentrations of the target marker/analyte.

analytical specificity

SOURCE: MDCG 2022-2 (IVD)

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.

authorised representative

SOURCE: IVDR, MDR

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

SOURCE: EN ISO 13485:2016

natural or legal person established within a country or jurisdiction who has received a written mandate from the manufacturer to act on his behalf for specified tasks with regard to the latter’s obligations under that country or jurisdiction’s legislation

B

basic UDI-DI 

SOURCE: MDR

The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.

Basic UDI-DI decision tool

This little tool will help you to determine if you need to introduce a new Basic UDI-DI for your device or if you can use an already existing one from another product of yours.

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batch 

SOURCE: ISO 20417:2021

See lot.

batch code

SOURCE: ISO 20417:2021

See lot-number.

batch number

SOURCE: ISO 20417:2021

See lot-number.

benefit

SOURCE: ISO 14971:2019

positive impact or desirable outcome of the use of a medical device on the health of an individual or a positive impact on patient management or public health

NOTE: Benefits can include positive impact on clinical outcome, the patient’s quality of life, outcomes related to diagnosis,  positive impact from diagnostic devices on clinical outcomes, or positive impact on public health.

benefit factor (BF)

SOURCE: ISO 10993-17:2009

numerical factor that takes into account the health benefit from use of the medical device(s) containing the leachable substance in question

benefit-risk determination

SOURCE: IVDR, MDR

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

biocompatibility

SOURCE: ISO 10993-1:2018

ability of a medical device or material to perform with an  appropriate host response in a specific application

biological risk

SOURCE: ISO 10993-1:2018

combination of the probability of harm to health occurring as a result of adverse reactions associated with medical device or material interactions, and the severity of that harm

biological safety

SOURCE: ISO 10993-1:2018

freedom from unacceptable biological risk in the context of the intended use

C

calibrator

SOURCE: IVDR

means a measurement reference material used in the calibration of a device

catalogue number 

SOURCE: ISO 20417:2021, EN ISO 15223-1:2021

value given by the manufacturer to identify a specific medical device or accessory as it relates to its form/fit, function and process (i.e., manufacturing processes requiring differentiation for the end user)

NOTE 1: A catalogue number shall consist of letters or numbers or a combination of these.

NOTE 2: For the purposes of this document, commercial product code should not be confused with the US FDA ‘product code’ or procode classification.

NOTE 3: Synonyms for catalogue number are “reference number” or “reorder number”.

NOTE 4: See figure 2 of ISO 20417:2021.

CE marking of conformity (CE marking)

SOURCE: IVDR, MDR

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

certified reference material/ standard reference material

SOURCE: WHO TGS-8

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.

certified reference methods

SOURCE: WHO TGS-8

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.

chemical characterization

SOURCE: ISO 10993-1:2018

process of obtaining chemical information, accomplished either by information gathering or by information generation, for example, by literature review or chemical testing

chemical constituent

SOURCE: ISO 10993-1:2018

any synthetic or natural substance that is used in a process for manufacturing materials and/or medical devices, including the base material(s), additives (antioxidants, UV stabilizers, color additives, dyes, etc.), and processing aids (solvents, lubricants, antifoaming agents, etc.)

chemical information

SOURCE: ISO 10993-1:2018

qualitative and quantitative, if applicable, knowledge related to the configuration, composition and production of the medical device and/or its materials of construction, thereby establishing the identities and amounts of constituents present in the materials and device

NOTE 1: See also 5.2.1, 5.2.2, 5.2.3, and Annex B of ISO 10993-18:2018

NOTE 4: Chemical information can be used to establish the hypothetical worst-case release of chemicals from a medical device, predicated on the circumstance that all chemicals present in the device are released from the device under its clinical conditions of use.

classification

SOURCE: MDR

devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks.

SOURCE: MDR

devices shall be divided into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks.

Classification tool for MDR/IVDR

Determine the risk class of your medical device now! The tool will guide you through a series of questions. At the end of which you will know the classification of your device.

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clearly legible

SOURCE: ISO 10993-1:2018

capable of being read by a person with normal vision

NOTE: There is guidance or rationale for this definition contained in Clause A.2 in ISO 10993-1:2018

clinical benefit

SOURCE: IVDR

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.

SOURCE: MDCG 2022-2 (IVD)

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.

SOURCE: MDR

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

clinical data

SOURCE: MDR

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 evaluation

SOURCE: EN ISO 13485:2016

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

clinical evidence

SOURCE: MDR

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

SOURCE: IVDR

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

clinical investigation

SOURCE: MDR

any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device

clinical investigation plan

SOURCE: MDR

a document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation

clinical performance

SOURCE: MDR

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

SOURCE: IVDR

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.

commercial product code 

SOURCE: ISO 20417:2021

commercial product name

SOURCE: ISO 20417:2021

common specifications (CS)

SOURCE: IVDR, MDR

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

companion diagnostic

SOURCE: IVDR

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

compatibility

SOURCE: IVDR, MDR

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

complaint

SOURCE: EN ISO 13485:2016

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.

NOTE: The definition of “complaint” differs from the definition given in ISO 9000:2015.

concomitant exposure factor (CEF)

SOURCE: ISO 10993-17:2009

numerical factor that accounts for patient exposure to many medical devices containing the same leachable substance

NOTE: This factor is used to adjust the product of TI and body mass downward.

configurations

SOURCE: MDR

Configuration is a combination of items of equipment, as specified by the manufacturer, that operate together as a device to achieve an intended purpose. The combination of items may be modified, adjusted or customized to meet specific needs.

Configurations include inter alia:

  • gantries, tubes, tables, consoles and other items of equipment that can be configured/combined to deliver an intended function in computed tomography.
  • ventilators, breathing circuits, vaporizers combined to deliver an intended function in anaesthesia.

conformity assessment

SOURCE: IVDR, MDR

the process of demonstrating whether the requirements of this Regulation relating to a device have been fulfilled

conformity assessment body

SOURCE: IVDR, MDR

a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection

control material

SOURCE: IVDR

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

corrective action

SOURCE: IVDR, MDR

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

correct use

SOURCE: IEC 62366-1:2015

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

NOTE 2: See figure under abnormal use, that shows the relationships of the types of use.

custom-made device

SOURCE: MDR

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

D

data set

SOURCE: ISO 10993-1:2018

information, such as physical and/or chemical characterization, toxicity data, etc. from a variety of sources necessary to characterize the biological response to a medical device 

default

SOURCE: ISO 10993-17:2009

value to be used, in the absence of data, for an uncertainty or other factor used in the calculation of the allowable limit

derivative

SOURCE: MDR

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

description 

SOURCE: EN ISO 15223:2021

normative text which defines the purpose, the application and the use of the symbol

device deficiency

SOURCE: IVDR

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

SOURCE: MDR

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

device for performance study

SOURCE: IVDR

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.

device for self-testing

SOURCE: IVDR

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

device for near-patient testing

SOURCE: IVDR

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;

diagnostic sensitivity

SOURCE: IVDR

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

diagnostic specificity

SOURCE: IVDR

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

direct contact

SOURCE: ISO 10993-1:2018

medical device or medical device component that comes into physical contact with body tissue

distributor

SOURCE: IVDR, MDR

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

SOURCE: EN ISO 13485:2016

natural or legal person in the supply chain who, on his own behalf, furthers the availability of a medical device to the end use

NOTE 1: More than one distributor may be involved in the supply chain.

NOTE 2: Persons in the supply chain involved in activities such as storage and transport on behalf of the manufacturer, importer or distributor, are not distributors under this definition.

SOURCE: ISO 20417:2021, EN ISO 15223:2021

natural or legal person, different from the manufacturer or importer, in the supply chain who, on their own behalf, furthers the availability of a medical device or accessory to the user

NOTE 1: More than one distributor may be involved in the supply chain.

NOTE 2: For the purposes of this document, persons in the supply chain involved in activities such as storage and transport on behalf of the manufacturer, importer or distributor, are not distributors.

NOTE 3: Distribution activities alone do not include repackaging or otherwise changing the container, wrapper, or accompanying information of the medical device or medical device package other than providing the identification of the distributor.

do not reuse

SOURCE: ISO 20147:2021

See single use.

E

economic operator

SOURCE: IVDR

SOURCE: MDR

a manufacturer, an authorised representative, an importer or a distributor or the person referred to in Article 22(1) and 22(3)

e-documentation (electronic documentation)

SOURCE: ISO 20147:2021

any form of electronically accessible information supplied by the manufacturer related to a medical device or accessory

effectiveness 

SOURCE: IEC 62366-1:2015

accuracy and completeness with which users achieve specified goals

NOTE: This is a different concept than ‘clinical effectiveness’.

efficiency

SOURCE: IEC 62366-1:2015

resources expended in relation to effectiveness

electronic instructions for use (eIFU)

any form of electronically accessible information supplied by the manufacturer related to a medical device or accessory

easily legible

SOURCE:  ISO 20417:2021

economic operator

SOURCE:  MDR

a manufacturer, an authorised representative, an importer, a distributor or the person referred to in MDR Article 22(1) and 22(3)

ethics committee

SOURCE: IVDR, MDR

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 lay persons, in particular patients or patients’ organisations

European Database on Medical Devices (Eudamed)

SOURCE: EU Commission – Eudamed

European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746).

EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU). It will integrate different electronic systems to collate and process information about medical devices and related companies (e.g. manufacturers). In doing so, EUDAMED aims to enhance overall transparency, including through better access to information for the public and healthcare professionals, and to enhance coordination between the different Member States in the EU.

EUDAMED will be composed of six modules related to: actor registration, unique device identification (UDI) and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and market surveillance.

expected lifetime

SOURCE:  ISO 20417:2021

also: expected service life

time period specified by the manufacturer during which the medical device or accessory is expected to remain safe and effective for use

NOTE 1: The expected lifetime can be affected by the stability.

NOTE 2: Maintenance, repairs or upgrades (e.g., safety or cybersecurity modifications) can be necessary during the expected lifetime.

NOTE 3: Some medical devices have an absolute lifetime (e.g., 5 y), whereas other medical devices (e.g., software) have a relative lifetime (e.g., the time between two major releases).

NOTE 4: There is guidance or rationale for this definition contained in Clause A.2 of ISO 20417:2021

expected service life

SOURCE:  IEC 62366-1:2015

time period specified by the manufacturer during which the medical device is expected to remain safe for use (i.e. maintain basic safety and essential performance)

NOTE: Maintenance can be necessary during the expected service life.

externally communicating medical device

SOURCE:  ISO 10993-1:2018

medical device or medical device component that is partially or wholly located outside the body but has either direct or indirect contact with the internal body fluids and/or tissues

F

false negative

SOURCE:  MDCG 2022-2 (IVD)

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

false positive

SOURCE:  MDCG 2022-2 (IVD)

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

falsified device

SOURCE:  IVDR, MDR

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

field safety corrective action (FSCA)

SOURCE:  IVDR, MDR

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

field safety notice (FSN)

SOURCE:  IVDR, MDR

means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action

final product

SOURCE:  ISO 10993-1:2018

medical device or medical device component that has been subjected to all manufacturing processes for the “to be marketed” medical device including packaging and if applicable, sterilization

formative evaluation

SOURCE:  ICE 62366-1:2015

user interface evaluation conducted with the intent to explore user interface design strengths, weaknesses, and unanticipated use errors

NOTE: Formative evaluation is generally performed iteratively throughout the design and development process, but prior to summative evaluation, to guide user interface design as necessary.

fully refurbiushing

SOURCE:  IVDR, MDR

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

G

generic device group

SOURCE:  IVDR, MDR

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

geometry device configuration

SOURCE:  ISO 10993-1:2018

shape and relative arrangement of the parts of the medical device

H

harm

SOURCE:  ISO 14971:2019

injury or damage to the health of people, or damage to property of the environment

harm to health

SOURCE:  ISO 10993-17:2009

physical injury and/or damage to health

harmonised standard

SOURCE:  IVDR, MDR

European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012

hazard

SOURCE:  ISO 14971:2019

potential source of harm

hazardous situation

SOURCE: ISO 14971:2019

circumstance in which people, property or the environment is/are exposed to one or more hazard

NOTE: See Annex C of ISO 14971:2019 for an explanation of the relationship between hazard and hazardous situation.

hazardous-related use scenario

SOURCE: IEC 62366-1:2015

Use scenario that could lead to a hazardous situation or harm

NOTE 1: A hazard-related use scenario can often be linked to a potential use error.

NOTE 2: A hazard-related use scenario is not related to a failure of the medical device, unless the medical device failure was caused by a use error.

health benefit

SOURCE: ISO 10993-17:2009

likelihood of maintaining or improving health

health hazard

SOURCE: ISO 10993-17:2009

combination of the likelihood of occurrence of harm to health and the severity of that harm

health institution

SOURCE: IVDR, MDR

an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health

health risk analysis

SOURCE: ISO 10993-17:2009

use of available information to identify health hazards and to estimate health risk

I

importer

SOURCE: IVDR, MDR

any natural or legal person established within the Union that places a device from a third country on the Union market

SOURCE: EN ISO 13485:2016

natural or legal person in the supply chain who is the first in a supply chain to make a medical device, manufactured in another country or jurisdiction, available in the country or jurisdiction where it is to be marketed

SOURCE: ISO 20417:2021, EN ISO 15223:2021

natural or legal person who imports a medical device or accessory into a locale that was manufactured in another locale for the purposes of marketing

implant

SOURCE: ISO 10993-1:2018

medical 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 means of clinical intervention and which is intended to remain in place after the procedure

implantable device

SOURCE: MDR

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

implantable medical device

SOURCE: EN ISO 13485:2016

medical device which can only be removed by medical or surgical intervention and which is intended to:

  • be totally or partially introduced into the human body or a natural orifice, or
  • replace an epithelial surface or the surface of the eye, and
  • remain after the procedure for at least 30 days

in vitro diagnostic medical device (IVD medical device)

SOURCE: IVDR

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;

SOURCE: ISO 14971:2019

device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes and including reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles.

incident

SOURCE: IVDR

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 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

SOURCE: MDR

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

(medical) indication

SOURCE: MDR, MEDDEV 2.7/1 rev. 4

Medical indication is a medical condition which can be treated / diagnosed / prevented / monitored /predicted / prognosed /alleviated. 

MEDDEV examples:

  • treatment of acute migraine

  • rehabilitation after stroke

  • migraine prophylaxis

This term (medical indication or medical condition) is an umbrella term for all diseases or disabilities that are treated, alleviated , diagnosed etc. by the product. A disease can also be a medical condition. 

The term “application area” is another term for Medical indication. 

indirect contact

SOURCE: ISO 10993-1:2018

medical device or medical device component through which a fluid or gas passes, prior to the fluid or gas coming into physical contact with body tissue (in this case the medical device or medical device component itself does not physically contact body tissue)

information for safety

SOURCE: ISO 20417:2021

information provided to the user or responsible organization as a risk control measure

EXAMPLE 1: Warnings, precautions or contraindications.

EXAMPLE 3: Explanation of a safety feature of a medical device.

NOTE 1: Information for safety may be found in any or all types of information supplied by the manufacturer.

NOTE 2: Information for safety can be located on the display of a medical device.

information supplied by the manufacturer

SOURCE: ISO 20417:2021, EN ISO 15223:2021

information related to the identification and use of a medical device or accessory, in whatever form provided, intended to ensure the safe and effective use of the medical device or accessory

NOTE 1: For the purposes of this document, e-documentation is included in information supplied by the manufacturer.

NOTE 2: For the purposes of this document, shipping documents and promotional material are excluded from information supplied by the manufacturer. However, some authorities having jurisdiction can consider such supplemental information as information supplied by the manufacturer.

NOTE 3: The primary purpose of information supplied by the manufacturer is to identify the medical device and its manufacturer, and provide essential information about its safety, performance, and appropriate use to the user or other relevant persons.

NOTE 4: See figure 1 of ISO 20417:2021

NOTE 5: There is guidance or rationale related to information supplied by the manufacturer in Annex A of ISO 20417:2021

informed consent

SOURCE: IVDR

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

SOURCE: MDR

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

instructions for use (IFU)

SOURCE: IVDR, MDR

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

SOURCE: ISO 20417:2021, EN ISO 15223:2021

also: package insert
portion of the accompanying information that is essential for the safe and effective use of a medical device or accessory directed to the user of the medical device

NOTE 1: For the purposes of this document, a user can be either a lay user or professional user with relevant specialized training.

NOTE 2: For the purposes of this document, instructions for the professional processing between uses of a medical device or accessory can be included in the instructions for use.

NOTE 3: The instructions for use, or portions thereof, can be located on the display of a medical device or accessory.

NOTE 4: Medical devices or accessories that can be used safely and effectively without instructions for use are exempted from having instructions for use by some authorities having jurisdiction.

NOTE 5: See figure 1 of ISO 20417:2021.

intended purpose

SOURCE: IVDR

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 performance evaluation

SOURCE: MDR

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

SOURCE: ISO 14971:2019

also: intended use
use for which a product, process or service is intended according to the specifications, instructions and information provided by the manufacturer

NOTE: The intended medical indication, patient population, part of the body or type of tissue interacted with, user profile, use environment, and operating principle are typical elements of the intended use.

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interoperability

SOURCE: IVDR, MDR

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

interventional clinical performance study

SOURCE: IVDR

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

invasive device

SOURCE: MDR

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

investigational device

SOURCE: MDR

a device that is assessed in a clinical investigation

investigator

SOURCE: IVDR

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

SOURCE: MDR

means an individual responsible for the conduct of a clinical investigation at a clinical investigation site

K

kit

SOURCE: IVDR

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;

L

label

SOURCE: IVDR, MDR

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

SOURCE: ISO 20417:2021, EN ISO 15223:2021

written, printed, or graphic information appearing on the item (medical device, accessory) itself, on the packaging of each item or on the packaging of multiple items

NOTE 1: For the purposes of document ISO 20417:2021, the term labelled is used to designate the corresponding act.

NOTE 2: Label includes the marking on the medical device or accessory.

NOTE 3: For the purposes of this document, information indicated on a graphical user interface (GUI) is considered as appearing on the item.

NOTE 4: See figure 1 of ISO 20417:2021.

labelled

SOURCE: ISO 20417:2021

see label

labelling

SOURCE: EN ISO 13485:2016

label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents

lay person

SOURCE: IVDR, MDR

an individual who does not have formal education in a relevant field of healthcare or medical discipline

SOURCE: ISO 20417:2021

individual who does not have formal education in a relevant field of healthcare or medical discipline and, if appropriate, relevant specialized training on the use of the specific medical device

leachable substance

SOURCE: ISO 10993-17:2009

chemical removed from a medical device by the action of water or other liquids related to the use of the device

NOTE: Additives, sterilant residues, process residues, degradation products, solvents, plasticizers, lubricants, catalysts, stabilizers, anti-oxidants, colouring agents, fillers and monomers, among others.

life cycle

SOURCE: ISO 14971:2019, EN ISO 13485:2016

series of all phases in the life of a medical device, form the initial conception to final decommissioning and disposal

likelihood ratio

SOURCE: IVDR

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

linearity

SOURCE: ISO 18113-1

ability to provide measured quantity values that are directly proportional to the value of the measurand in the sample.

local actor administrator (LAA)

An authorised user who has the right to manage certain information regarding  the details of the actor and to grant access to Eudamed via the restricted website to other natural persons to act on behalf of that actor;

local user administrator (LUA)

An authorised user who has the right to grant access to Eudamed via the restricted website to other natural persons to act on behalf of an actor;

lot

SOURCE: 20417:2021

also: batch
defined amount of material or a number of medical devices, including finished product and accessories, that is manufactured in one process or a series of related processes and is intended to be homogenous

NOTE 1: A lot or batch is manufactured under essentially the same conditions and is intended to have uniform characteristics and quality within specified limits. A lot or batch is considered homogeneous when equivalent parts or materials are manufactured or tested in the same manner, without interruption, typically on the same day or in the same time period, and produced by the same person or with the same machine/equipment set-up and fulfil the same quality specification.

NOTE 2: The defined amount of material or number of medical devices or accessories is normally associated with a unique statement of conformity to a defined quality specification.

lot code

SOURCE: ISO 20417:2021

also: batch code, batch number, lot code
production control containing a combination of letters or numbers associated with a single lot or batch

lot number

SOURCE: 20417:2021

also: batch code, batch number, lot code
production control containing a combination of letters or numbers associated with a single lot or batch

lowest observed adverse effect level (LOAL)

SOURCE: ISO 10993-17:2009

lowest concentration or amount of a substance found by experiment or observation which causes detectable adverse alteration of morphology, functional capacity, growth, development or life span of the target organism under defined conditions of exposure

NOTE: Alterations of morphology, functional capacity, growth, development or life span of the target organism may be detected which are judged not to be adverse.

M

making available on the market

SOURCE: IVDR

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;

SOURCE: MDR

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

manufacturer

SOURCE: IVDR, MDR

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 trade mark

SOURCE: ISO 14971:2019, EN ISO 13485:2016, EN ISO 15223-1:2021

natural or legal person with responsibility for the design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name, whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s).

NOTE 1: The natural or legal person has ultimate legal responsibility for ensuring compliance with all  applicable regulatory requirements for the medical device in the countries or jurisdictions where it is intended to be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory Authority (RA) within that jurisdiction.

NOTE 2: The manufacturer’s responsibilities are described in other GHTF guidance documents. These responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse event reporting and notification of corrective actions.

NOTE 3: “Design and/or manufacture” may include specification development, production, fabrication, assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or remanufacturing of a medical device; or putting a collection of devices, and possibly other products, together for a medical purpose.

NOTE 4: Any person who assembles or adapts a medical device that has already been supplied by another person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided the assembly or adaptation does not change the intended use of the medical device.

NOTE 5: Any person who changes the intended use of, or modifies, a medical device without acting on behalf of the original manufacturer and who makes it available for use under his own name, should be  considered the manufacturer of the modified medical device.

NOTE 6: An authorised representative, distributor or importer who only adds its own address and contact details to the medical device or the packaging, without covering or changing the existing labelling, is not considered a manufacturer.

NOTE 7: To the extent that an accessory is subject to the regulatory requirements of a medical device, the person responsible for the design and/or manufacture of that accessory is considered to be a manufacturer.

marked

SOURCE: ISO 20417:2021

see marking

market surveillance

SOURCE: IVDR, MDR

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

marking

SOURCE: ISO 20417:2021

information, in text or graphical format, durably affixed, printed, etched (or equivalent) to a medical device or accessory

NOTE 1: For the purposes of ISO 20417:2021, the term marked is used to designate the corresponding act.

NOTE 2: For the purposes of ISO 20417:2021, marking is different from ‘direct marking’ as commonly described in unique device identification (UDI) standards and regulations. A UDI ‘direct marking’ is a type of marking.

NOTE 3: See Figure 1 of ISO 20417:2021.

material

SOURCE: ISO 10993-1:2018

synthetic or natural polymer, metal or alloy, ceramic, or composite, including tissue rendered non-viable, used as a medical device or any part thereof

material characterization

SOURCE: ISO 10993-1:2018

broad and general process of collecting existing information about a material’s chemistry, structure and other properties, and if appropriate, new data, to facilitate the evaluation of these properties

measuring interval (range)

SOURCE: International vocabulary of metrology

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

medical condition

SOURCE: MDCG 2020-7, MDCG 2020-8

refers to the clinical condition that is to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled by the medical device.

medical device

SOURCE: IVDR, MDR

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) of the MDR and of those referred to in the first paragraph of this point.

SOURCE: ISO 14971:2019, EN ISO 13485:2016, EN ISO 15223-1:2021

instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
  • investigation, replacement, modification, or support of the anatomy or of a physiological process,
  • supporting or sustaining life,
  • control of conception,
  • disinfection of medical devices,
  • providing information by means of in vitro examination of specimens derived from the human body

and which does not achieve its primary 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.

NOTE 1: Products which can be considered to be medical devices in some jurisdictions but not in others include:

  • disinfection substances;
  • devices incorporating animal and/or human tissues;
  • aids for persons with disabilities;
  • devices for in vitro fertilization or assisted reproduction technologies.

medical device family

SOURCE: EN ISO 13485:2016

group of medical devices manufactured by or for the same organization and having the same basic design and performance characteristics related to safety, intended use and function

model

SOURCE: ISO 20417:2021

model number

SOURCE: ISO 20417:2021, EN ISO 15223:2021

also: model
letters, numbers or a combination of these assigned by a manufacturer to distinguish by function or type, a particular medical device, accessory or medical device family from another

NOTE: See figure 2 of ISO 20417:2021.

multiple patient multiple use 

SOURCE: ISO 20417:2021

medical device or accessory intended by the manufacturer to be reused on multiple patients for multiple uses

NOTE 1: A multiple patient multiple use medical device or accessory typically requires processing between patients.

NOTE 2: A multiple patient multiple use medical device or accessory may require processing between uses on a single patient.

N

nanomaterial

SOURCE: MDR

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

SOURCE: ISO 10993-1:2018

Material with any external dimension in the nanoscale or having internal structure or surface structure in the nanoscale

negative predictive value

SOURCE: IVDR

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

non-contacting

SOURCE: ISO 10993-1:2018

indicates that the medical device or medical device component has neither direct nor indirect contact with body tissues

notified body

SOURCE: IVDR, MDR

a conformity assessment body designated in accordance with this Regulation (MDR/IVDR)

non-viable

SOURCE: MDR

having no potential for metabolism or multiplication

normal use

SOURCE: IEC 62366-1:2015

operation, including routine inspection and adjustments by any user, and stand-by, according to the instructions for use or in accordance with generally accepted practice for those medical devices provided without instructions for use

NOTE 1: Normal use should not be confused with intended use. While both include the concept of use as intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates not only the medical purpose, but maintenance, transport, etc. as well.

NOTE 2: Use error can occur in normal use.

O

objective evidence

SOURCE: ISO 14971:2019

data supporting the existence or verity of something

NOTE: Objective evidence can be obtained through observation, measurement, test or by other means.

P

package insert

SOURCE: ISO 20417:2021

particle

SOURCE: MDR

for the purposes of the definition of nanomaterial, means a minute piece of matter with defined physical boundaries

patient

SOURCE: IEC 62366-1:2015

living being (person) undergoing a medical, surgical or dental procedure

NOTE: A patient can be a user.

performance

SOURCE: IVDR

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.

SOURCE: MDR

the ability of a device to achieve its intended purpose as stated by the manufacturer

performance evaluation

SOURCE: IVDR

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

SOURCE: EN ISO 13485:2016

assessment and analysis of data to establish or verify the ability of an in vitro diagnostic medical device to achieve its intended use

performance study

SOURCE: IVDR

means a study undertaken to establish or confirm the analytical or clinical performance of a device

performance study plan

SOURCE: IVDR

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

performance of a device

person responsible for regulatory compliance (PRRC)

SOURCE: MDR

Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices

physical and chemical information

SOURCE: ISO 10993-1:2018

knowledge regarding formulation, manufacturing processes, geometric and physical properties and type of body contact and clinical use that is used to determine whether any additional biological or material characterization testing is needed

physiologically based pharmacokinetic modelling (PBPK modelling)

SOURCE: ISO 10993-17:2002

system of modelling biological effects taking into account metabolic and pharmacokinetic differences among species of animal

NOTE: Such data should be utilized whenever they are available.

pictogram

SOURCE: ISO 20417:2021

simplified pictorial representation, used to guide people and tell them how to achieve a certain goal

placing on the market

SOURCE: IVDR

the first making available of a device, other than a device for performance study, on the Union market;

SOURCE: MDR

the first making available of a device, other than an investigational device, on the Union market

positive predictive value

SOURCE: IVDR

means the ability of a device to separate true positive results from false positive results for a given attribute in a given population

post-market surveillance

SOURCE: IVDR, MDR

means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions

SOURCE: EN ISO 13485:2016

systematic process to collect and analyse experience gained from medical devices that have been placed on the market

post-production

SOURCE: ISO 14971:2019

part of the life cycle of the medical device after the design has been completed and the medical device has been manufactured

EXAMPLE: Transportation, storage, installation, product use, maintenance, repair, product changes, decommissioning and disposal.

precaution

SOURCE: ISO 18113-1:2009

statement that alerts users to special care or activities necessary for safe and effective use of an IVD medical device or to avoid damage to the IVD medical device that could occur as a result of use, including misuse

NOTE 1: The distinction between warnings and precautions is a matter of degree, considering the likelihood and seriousness of the hazard. See the definition of warning.

NOTE 2: Adapted from U.S. Food and Drug Administration, Guidance on Medical Device Patient Labelling; Final Guidance for Industry and FDA, 19 April 2001

predictive value

SOURCE: IVDR

means the probability that a person with a positive device test result has a given condition under investigation, or that a person with a negative device test result does not have a given condition

primary operating function

SOURCE: ICE 62366-1:2015

function that involves user interaction that is related to the safety of the medical device

NOTE 1: Often a primary operating function is interacted with by a series of tasks that can be broken down into a series of user interactions

NOTE 2: The concept of safety includes loss or degradation of performance resulting in an unacceptable risk to the patient, including use error that prevents the user from effectively using the medical device to achieve its intended medical purpose. In IEC 60601-1, this is referred to as ‘essential performance’.

procedure

SOURCE: ISO 14971:2019

specified way to carry out an activity or a process

NOTE: Procedures can be documented or not.

procedure pack

SOURCE: MDR

a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose

process

SOURCE: ISO 14971:2019

set of interrelated or interacting activities that use inputs to deliver an intended result

NOTE 1: Whether the “intended result” of a process is called output, product or service depends on the context of the reference.

NOTE 2: Inputs to a process are generally the outputs of other processes and outputs of a process are generally the inputs to other processes.

NOTE 3: Two or more interrelated and interacting processes in series can also be referred to as a process.

processing

SOURCE: ISO 20417:2021

activity to prepare a new or used medical device or accessory for its intended use

product

SOURCE: EN ISO 13485:2016

result of a process

NOTE 1: There are four generic product categories, as follows:

  • services (e.g. transport);
  • software (e.g. computer program, dictionary);
  • hardware (e.g. engine mechanical part);
  • processed materials (e.g. lubricant)

Many products comprise elements belonging to different generic product categories. Whether the product is then called service, software, hardware or processed material depends on the dominant element. For example, the offered product “automobile” consists of hardware (e.g. tyres), processed materials (e.g. fuel, cooling liquid), software (e.g. engine control software, driver’s manual), and service (e.g. operating explanations given by the salesman).

NOTE 2: Service is the result of at least one activity necessarily performed at the interface between the supplier and customer and is generally intangible. Provision of a service can involve, for example, the following:

  • an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired);
  • an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return);
  • the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission);
  • the creation of ambience for the customer (e.g. in hotels and restaurants).

Software consists of information and is generally intangible and can be in the form of approaches, transactions or procedures. Hardware is generally tangible and its amount is a countable characteristic. Processed materials are generally tangible and their amount is a continuous characteristic. Hardware and processed materials often are referred to as goods.

NOTE 3: This definition of “product” differs from the definition given in ISO 9000:2015.

product code

SOURCE: ISO 20417:2021

product name

SOURCE: ISO 20417:2021

purchased product

SOURCE: EN ISO 13485:2016

product provided by a party outside the organization’s quality management system

NOTE: The provision of product does not necessarily infer a commercial or financial arrangement.

proportional exposure factor (PEF)

SOURCE: ISO 10993-17:2009

numerical factor for patient exposure to a leachable substance that accounts for the fact that a medical device is not typically utilized every day during the entire exposure category of interest

NOTE: This factor is used to adjust the product of TI and body mass upwards.

putting into service

SOURCE: IVDR

the stage at which a device, other than a device for performance study, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose;

SOURCE: MDR

the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose

R

reasonably foreseeable misuse

SOURCE: ISO 14971:2019

use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behaviour.

NOTE 1: Readily predictable human behaviour includes the behaviour of all types of users, e.g. lay and professional users.

NOTE 2: Reasonably foreseeable misuse can be intentional or unintentional.

recall

SOURCE: MDR

means any measure aimed at achieving the return of a device that has already been made available to the end user

record

SOURCE: ISO 14971:2019

document stating results achieved or providing evidence of activities performed

NOTE 1: Records can be used, for example, to formalize traceability and to provide evidence of verification, preventive action and corrective action.

NOTE 2: Generally records need not be under revision control.

repeated use

SOURCE: ISO 10993-17:2009

use of the same device by the same patient more than once without reprocessing

reprocessing

SOURCE: MDR

a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device

residual risk

SOURCE: ISO 14971:2019

risk remaining after risk control measures have been implemented

responsible organization

SOURCE: IEC 62366-1:2015

entity accountable for the use and maintenance of a medical device or combination of medical devices

NOTE 1: The accountable entity can be, for example, a hospital, an individual clinician or a lay person. In home use applications, the patient, user and responsible organization can be one and the same person.

NOTE 2: Education and training are included in “use”.

risk

SOURCE: IVDR, MDR, ISO 14971:2019, EN ISO 15223:2021, EN ISO 13485

the combination of the probability of occurrence of harm and the severity of that harm

risk analysis

SOURCE: ISO 14971:2019

systematic use of available information to identify hazards and to estimate the risk

risk assessment

SOURCE: ISO 14971:2019

overall process comprising a risk analysis and a risk evaluation

risk control

SOURCE: ISO 14971:2019

process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels

risk estimation

SOURCE: ISO 14971:2019

process used to assign values to the probability of occurrence of harm and the severity of that harm

risk evaluation

SOURCE: ISO 14971:2019

process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk

risk management

SOURCE: ISO 14971:2019, EN ISO 13485:2016

systematic application of management policies, procedures  and practices to the tasks of analysing, evaluating, controlling and monitoring risk

risk management file

SOURCE: ISO 14971:2019

set of records and other documents that are produced by risk management

risk management report

SOURCE: ISO 14971:2019

Documented output of the risk management review

risk management review

SOURCE: ISO 14971:2019

Review of the execution of the risk management plan by the manufacturer.

S

safety

SOURCE: ISO 14971:2019, ISO 10993-17:2009

freedom from unacceptable risk

safety sign

SOURCE: ISO 20417:2021

sign giving a general safety message, obtained by a combination of a colour and geometric shape and which, by the addition of a graphical symbol, gives a particular safety message

scientific validity of an analyte

SOURCE: IVDR

means the association of an analyte with a clinical condition or a physiological state

serial number

SOURCE: ISO 20417:2021

production control containing a combination of letters or numbers, selected by the manufacturer, intended for quality control and identification purposes to uniquely distinguish an individual medical device from other medical devices with the same catalogue number or model number

serious adverse event

SOURCE: IVDR

means any adverse event that led to any of the following:

(a) a patient management decision resulting in death or an imminent life-threatening situation for the individual being tested, or in the death of the individual’s offspring,
(b) death,
(c) serious deterioration in the health of the individual being tested or the recipient of tested donations or materials, that resulted in any of the following:

(i) life-threatening illness or injury,
(ii) permanent impairment of a body structure or a body function,
(iii) hospitalisation or prolongation of patient hospitalisation,
(iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
(v) chronic disease,

(d) foetal distress, foetal death or a congenital physical or mental impairment or birth defect

SOURCE: MDR

means any adverse event that led to any of the following:

(a) death,
(b) serious deterioration in the health of the subject, that resulted in any of the following:

(i) life-threatening illness or injury,
(ii) permanent impairment of a body structure or a body function,
(iii) hospitalisation or prolongation of patient hospitalisation,
(iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
(v) chronic disease,

(c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect

serious incident

SOURCE: IVDR, MDR

any incident that directly or indirectly led, might have led or might lead to any of the following:

(a) the death of a patient, user or other person,
(b) the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health,
(c) a serious public health threat

serious public health threat

SOURCE: IVDR, MDR

means an event which could result in imminent risk of death, serious deterioration in a person’s state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time

service personnel

SOURCE: ISO 20417:2021

individuals or entity accountable to the responsible organization that install, assemble, maintain or repair a medical device or accessory

severity

SOURCE: ISO 14971:2019

measure of the possible consequences of a hazard

shelf-life

SOURCE: ISO 20417:2021

period of time until the expiry date during which a medical device or accessory in its original packaging maintains its stability under the conditions specified in the information supplied by the manufacturer

simultaneous use

SOURCE: ISO 10993-17:2009

use of more than one device by the same patient at the same time

singe patient multiple use

SOURCE: ISO 20417:2021, EN ISO 15223:2021

medical device or accessory intended by the manufacturer to be reused on an individual patient for multiple uses

NOTE 1: A single patient multiple use medical device or accessory may require processing between uses.

NOTE 2: For an implantable medical device, the duration of a single use is from implanting to explanting the medical device.

single use

SOURCE: ISO 20417:2021

also: do not re-use, use only once
medical device, accessory intended by the manufacturer to be used on an individual patient or specimen during a single procedure and then disposed of

NOTE: A single use medical device or accessory is not intended by its manufacturer to be further processed and used again.

single-use device

SOURCE: IVDR, MDR

a device that is intended to be used on one individual during a single procedure

specimen receptacle

SOURCE: IVDR

device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination

sponsor

SOURCE: IVDR

means any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the performance study

SOURCE: MDR

means any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the clinical investigation

stability

SOURCE: ISO 20417:2021

concerning medical device or accessory: ability to maintain safety and performance characteristics within the specifications in information supplied by the manufacturer

NOTE 1: Stability applies to:

  • medical devices whose performance, physical, chemical or functional properties can be altered or compromised over a stated time interval;
  • the period of time over which sterility is assured;
  • IVD reagents, calibrators and controls, when stored, transported and used in accordance with conditions specified in the information supplied by the manufacturer
  • reconstituted lyophilized materials, working solutions and material removed from sealed containers, when prepared, used and stored according to the information supplied by the manufacturer; and
  • measuring instruments or measuring systems after calibration.

NOTE 2: Stability of an IVD reagent or measuring system is normally quantified with respect to time:

  • in terms of the duration of a time interval over which a measured property changes by a stated amount; or
  • in terms of the change of a property under specified conditions.

state of the art

SOURCE: ISO 14971:2019

developed stage of technical capability at a given time as regards products, processes and services, based on the relevant consolidated findings of science, technology and experience

NOTE: The state of the art embodies what is currently and generally accepted as good practice in technology and medicine. The state of the art does not necessarily imply the most technologically advanced solution. The state of the art described here is sometimes referred to as the “generally acknowledged state of the art”.

sterile

SOURCE: ISO 20417:2021, EN ISO 15223:2021

free from viable microorganisms

sterile barrier system

SOURCE: EN ISO 13485:2016

minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use

sterile medical device

SOURCE: EN ISO 13485:2016

medical device intended to meet the requirements for sterility

NOTE: The requirements for sterility of a medical device can be subject to applicable regulatory requirements or standards.

subject

SOURCE: MDR

means an individual who participates in a clinical investigation

SOURCE: IVDR

means an individual who participates in a performance study and whose specimen(s) undergo in vitro examination by a device for performance study and/or by a device used for control purposes;

summative evaluation

SOURCE: IEC 62366-1:2015

user interface evaluation conducted at the end of the user interface development with the intent to obtain objective evidence that the user interface can be used safely

symbol

SOURCE: ISO 20417:2021, EN ISO 15223:2021

graphical representation appearing on the label and/or associated documentation of a medical device that communicates characteristic information without the need for the supplier or receiver of the information to have knowledge of the language of a particular nation or people

NOTE: The symbol can be an abstract pictorial or a graphical representation, or one that uses familiar objects, including alphanumeric characters (with sufficient justification).

system

SOURCE: MDR

a combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose

T

task

SOURCE: IEC 62366-1:2015

one or more user interactions with a medical device to achieve a desired result

NOTE 1: A task description should include the allocation of activities and operational steps between the user and the medical device.

NOTE 2: Tasks should not be described solely in terms of the functions or features provided by the medical device.

technical description

SOURCE: ISO 20417:2021

portion of the accompanying information directed to the responsible organization and service personnel that is essential for preparation for the first use and safe use, maintenance or repair as well as processing, transport or storage for the expected lifetime of a medical device

NOTE 1: The technical description may be included in the instructions for use.

NOTE 2: See figure 1 of ISO 20417:2021

threshold of toxicological concern (TTC)

SOURCE: ISO 10993-17:2009

level of exposure for constituents, below which there would be no appreciable risk to human health

NOTE: See ISO/TS 21726 for full context.

tolerable contact level (TCL)

SOURCE: ISO 10993-17:2009

tolerable contact exposure to a leachable substance resulting from contact with a medical device

NOTE: It is normally expressed in milligrams per square centimetre of body surface.

tolerable exposure (TE)

SOURCE: ISO 10993-17:2009

product of the tolerable intake, the body mass and the utilization factor

NOTE: It is normally expressed in milligrams per day to the patient.

tolerable intake (TI)

SOURCE: ISO 10993-17:2009

estimate of the average daily intake of a substance over a specified time period, on the basis of body mass, that is considered to be without appreciable harm to health

NOTE: It is normally expressed in milligrams per kilogram of body mass per day. It is derived as a part of the overall establishment of allowable limits for a leachable substance in a medical device.

tolerable risk

SOURCE: ISO 10993-17:2009

risk which is accepted in a given context based upon the current values of society

top management

SOURCE: ISO 14971:2019

person or group of people who directs and controls a manufacturer at the highest level

toxic

SOURCE: ISO 10993-1:2018

capable of causing an adverse biological response

toxicological hazard

SOURCE: ISO 10993-1:2018

potential for a chemical substance or material to cause an adverse biological reaction, taking into account the nature of the reaction and the dose required to elicit it

toxicological risk

SOURCE: ISO 10993-1:2018

probability of a specified degree of an adverse reaction occurring in response to a specified level of exposure

toxicological threshold

SOURCE: ISO 10993-1:2018

limit, such as a tolerable intake (TI), tolerable exposure (TE), allowable limit (AL) value, or Threshold of Toxicological Concern (TTC) below which adverse effects are not expected for relevant biological endpoints

transitory contact

SOURCE: ISO 10993-1:2018

medical device or medical device component that has a very brief duration of contact with body tissue

U

UDI carrier

SOURCE: ISO 20417:2021

means to convey the UDI by using automatic identification and data capture (AIDC) and, if applicable, its human readable interpretation (HRI)

NOTE: UDI carriers can include 1D/linear bar code, 2D/Matrix bar code, RFID, etc.

unique device identifier (UDI)

SOURCE: IVDR, MDR

a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market

uncertainty factor 

SOURCE: ISO 10993-17:2009

means to convey the UDI by using automatic identification and data capture (AIDC) and, if applicable, its human readable interpretation (HRI)

NOTE: UDI carriers can include 1D/linear bar code, 2D/Matrix bar code, RFID, etc.

usability

SOURCE: IEC 62366-1:2015

characteristic of the user interface that facilitates use and thereby establishes effectiveness, efficiency and user satisfaction in the intended use environment

NOTE: All aspects of usability, including effectiveness, efficiency and user satisfaction, can either increase or decrease safety

usability engineering

SOURCE: IEC 62366-1:2015

also: human factors engineering

application of knowledge about human behaviour, abilities, limitations, and other characteristics to the design of medical devices (including software), systems and tasks to achieve adequate usability

NOTE: Achieving adequate usability can result in acceptable risk related to use.

SOURCE: MDCG 2022-2 (IVD)

application of knowledge about human behaviour, abilities, limitations, and other characteristics to the design of and interactions with an IVD medical devices (including software) to achieve adequate usability.

usability engineering file

SOURCE: IEC 62366-1:2015

set of records and other documents that are produced by the usability engineering process

usability test

SOURCE: IEC 62366-1:2015

method for exploring or evaluating a user interface with intended users within a specified intended use environment

use environment

SOURCE: IEC 62366-1:2015

actual conditions and setting in which users interact with the medical device

NOTE: The conditions of use or attributes of the use environment can include hygienic requirements, frequency of use, location, lighting, noise, temperature, mobility, and degree of internationalization.

use error

SOURCE: IEC 62366-1:2015

user action or lack of user action while using the medical device that leads to a different result than that intended by the manufacturer or expected by the user

NOTE 1: Use error includes the inability of the user to complete a task.

NOTE 2: Use errors can result from a mismatch between the characteristics of the user, user interface, task, or use environment.

NOTE 3: Users might be aware or unaware that a use error has occurred.

NOTE 4: An unexpected physiological response of the patient is not by itself considered use error.

NOTE 5: A malfunction of a medical device that causes an unexpected result is not considered a use error.

NOTE 6: See figure under abnormal use, that shows the relationships of the types of use.

use only once

SOURCE: ISO 20417:2021

user

SOURCE: IVDR, MDR

any healthcare professional or lay person who uses a device

SOURCE: IEC 62366-1:2015

person interacting with (i.e. operating or handling) the medical device

NOTE 1: There can be more than one user of a medical device.

NOTE 2: Common users include clinicians, patients, cleaners, maintenance and service personnel.

user group

SOURCE: IEC 62366-1:2015

subset of intended users who are differentiated from other intended users by factors that are likely to influence usability, such as age, culture, expertise or type of interaction with a medical device

user interface

SOURCE: IEC 62366-1:2015

means by which the user and the medical device interact

NOTE 1: Accompanying documentation is considered part of the medical device and its user interface. 

NOTE 2: User interface  includes all the elements of the medical device with which the user interacts including the physical aspects of the medical device as well as visual, auditory, tactile displays and is not limited to a software interface.

NOTE 3: For the purposes of this standard, a system of medical device can be treated as a single user interface.

user interface evaluation

SOURCE: IEC 62366-1:2015

process by which the manufacturer explores or assesses the user interactions with the user interface

NOTE 1: A user interface evaluation may consist of one or more of the following techniques, amongst others, usability tests, expert reviews, heuristic analyses, design audits or a cognitive walk through.

NOTE 2: User interface evaluation is frequently performed iteratively throughout the design and development process (this is formative evaluation).

NOTE 3: User interface evaluation is a part of the activities involved in verifying and validating the overall medical device design (this is summative evaluation).

user interface of unknown provenance (UOUP)

SOURCE: IEC 62366-1:2015

user interface or part of a user interface of a medical device previously developed for which adequate records of the usability engineering process according to IEC 62366-1:2015 are not available

user interface specification

SOURCE: IEC 62366-1:2015

collection of specifications that comprehensively and prospectively describe the user interface of a medical device

user profile

SOURCE: IEC 62366-1:2015

summary of the mental, physical and demographic traits of an intended user group, as well as any special characteristics, such as occupational skills, job requirements and working conditions, which can have a bearing on design decisions

use scenario

SOURCE: IEC 62366-1:2015

specific sequence of tasks performed by a specific user in a specific use environment and any resulting response of the medical device

use specification

SOURCE: IEC 62366-1:2015

also: application specification

summary of the important characteristics related to the context of use of the medical device

NOTE 1: The intended medical indication, patient population, part of the body or type of tissue interacted with, user profile, use environment, and operating principle are typical elements of the use specification.

NOTE 2: The summary of the medical device use specification is referred to by some authorities having jurisdiction as the ‘statement of intended use’.

NOTE 3: The use specification is an input to determining the intended use of ISO 14971:2007.

utilization factor (UTF)

SOURCE: ISO 10993-17:2009

numerical factor used to take into account the utilization of the device in terms of frequency of use and utilization in conjunction with other medical devices that can be reasonably anticipated to contain the same leachable substance

V

verification

SOURCE: ISO 14971:2019

confirmation, through the provision of objective evidence, that specified requirements have been fulfilled

NOTE 1: The objective evidence needed for a verification can be the result of an inspection or of other forms of determination such as performing alternative calculations or reviewing documents.

NOTE 2: The activities carried out for verification are sometimes called a qualification process.

NOTE 3: The word “verified” is used to designate the corresponding status.

W

warning

SOURCE: ISO 18113-1:2009

statement that alerts users about a situation that, if not avoided, could result in hazards or other serious adverse consequences from the use of an IVD medical device

NOTE 1: The designation of a hazard alert as a warning is reserved for the most significant consequences.

NOTE 2: The distinction between a warning and a precaution is a matter of degree, considering the likelihood and seriousness of the hazard.

NOTE 3: Use includes use errors and reasonably foreseeable misuse. See ISO 14971 and IEC 62366 for discussions of these concepts.

NOTE 4: Adapted from U.S. Food and Drug Administration, Guidance on Medical Device Patient Labelling; Final Guidance for Industry and FDA, 19 April 2001

withdrawal

SOURCE: IVDR, MDR

means any measure aimed at preventing a device in the supply chain from being further made available on the market