Glossary for medical device manufacturers

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Accessory for a medical device

‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);

MDR (EU) 2017/745

Accessories for medical devices

Accessory for an in vitro diagnostic medical device

‘accessory for an in vitro diagnostic medical device’ means an article which, whilst not being itself an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable the in vitro diagnostic medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the in vitro diagnostic medical device(s) in terms of its/their intended purpose(s);

IVDR (EU) 2017/746

accompanying documentation

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 to entry: The accompanying documentation can consist of the instructions for use, technical description, installation manual, quick reference guide, etc.

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

ISO 14971:2019

Active device

‘active device’ means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.

Software shall also be deemed to be an active device;

MDR (EU) 2017/745

Classification

Adverse event (IVDR (EU) 2017/746)

‘adverse event’ means any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a performance study, whether or not related to the device for performance study;

IVDR (EU) 2017/746

Adverse event (MDR (EU) 2017/7445)

‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device;

MDR (EU) 2017/745

Agglomerate

‘agglomerate’, for the purposes of the definition of nanomaterial in point (18), means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components;

MDR (EU) 2017/745

Aggregate

‘aggregate’, for the purposes of the definition of nanomaterial in point (18), means a particle comprising of strongly bound or fused particles;

MDR (EU) 2017/745

Analytical performance

‘analytical performance’ means the ability of a device to correctly detect or measure a particular analyte;

IVDR (EU) 2017/746

Authorised representative

‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;

MDR (EU) 2017/745

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Benefit

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 1 to entry: 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.

ISO 14971:2019

Benefit-risk determination

‘benefit-risk determination’ means the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer;

MDR (EU) 2017/745

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Calibrator

‘calibrator’ means a measurement reference material used in the calibration of a device;

IVDR (EU) 2017/746

CE marking of conformity / CE marking

‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing;

MDR (EU) 2017/745

CE marking

Clinical benefit (IVDR (EU) 2017/746)

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

IVDR (EU) 2017/746

Clinical benefit (MDR (EU) 2017/745)

‘clinical benefit’ means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health;

MDR (EU) 2017/745

Clinical data

‘clinical data’ means information concerning safety or performance that is generated from the use of a device and is sourced from the following:

• clinical Investigation(s) of the device concerned,
• clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated,
• reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated,
• clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up;

MDR (EU) 2017/745

Clinical evaluation

‘clinical evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

MDR (EU) 2017/745

Clinical evaluation

Clinical evidence (IVDR (EU) 2017/746)

‘clinical evidence’ means clinical data and performance evaluation results, pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

IVDR (EU) 2017/746

Clinical evidence (MDR (EU) 2017/745)

‘clinical evidence’ means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

MDR (EU) 2017/745

Clinical investigation

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

MDR (EU) 2017/745

Clinical investigation plan

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

MDR (EU) 2017/745

Clinical performance (IVDR (EU) 2017/746)

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

IVDR (EU) 2017/746

Clinical performance (MDR (EU) 2017/745)

‘clinical performance’ means the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer;

MDR (EU) 2017/745

Common specifications

‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.

MDR (EU) 2017/745

Companion diagnostic

‘companion diagnostic’ means a device which is essential for the safe and effective use of a corresponding medicinal product to:

1. identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
2. 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;

IVDR (EU) 2017/746

Compatibility

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

1. perform without losing or compromising the ability to perform as intended, and/or
2. integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or
3. be used together without conflict/interference or adverse reaction.

MDR (EU) 2017/745

Conformity assessment

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

MDR (EU) 2017/745

Conformity assessment

Conformity assessment body

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

MDR (EU) 2017/745

Control material

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

IVDR (EU) 2017/746

Corrective action

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

MDR (EU) 2017/745

Custom-made device

‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.

However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;

MDR (EU) 2017/745

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Derivative

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

MDR (EU) 2017/745

Device deficiency

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

MDR (EU) 2017/745

Device for near-patient testing

‘device for near-patient testing’ means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional;

IVDR (EU) 2017/746

Device for performance study

‘device for performance study’ means a device intended by the manufacturer to be used in a performance study.

A device intended to be used for research purposes, without any medical objective, shall not be deemed to be a device for performance study;

IVDR (EU) 2017/746

Device for self-testing

‘device for self-testing’ means any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services;

IVDR (EU) 2017/746

Diagnostic sensitivity

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

IVDR (EU) 2017/746

Diagnostic specificity

‘diagnostic specificity’ means the ability of a device to recognise the absence of a target marker associated with a particular disease or condition;

IVDR (EU) 2017/746

Distributor

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

MDR (EU) 2017/745

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Economic operator (IVDR (EU) 2017/746)

‘economic operator’ means a manufacturer, an authorised representative, an importer or a distributor;

IVDR (EU) 2017/746

Economic operator (MDR (EU) 2017/745)

‘economic operator’ means a manufacturer, an authorised representative, an importer, a distributor or the person referred to MDR (EU) 2017/745 in Article 22(1) and 22(3);

MDR (EU) 2017/745

Ethics committee

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

MDR (EU) 2017/745

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Falsified device

‘falsified device’ means any device with a false presentation of its identity and/or of its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights;

MDR (EU) 2017/745

Field safety corrective action

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

MDR (EU) 2017/745

Field safety notice

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

MDR (EU) 2017/745

Fully refurbishing

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

MDR (EU) 2017/745

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Generic device group

‘generic device group’ means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;

MDR (EU) 2017/745

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harm

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

ISO 14971:2019

[SOURCE: ISO/IEC Guide 63:2019, 3.2]

Harmonised standard

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

MDR (EU) 2017/745

Harmonized standards

Hazardous situation

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

Note 1 to entry: See Annex C for an explanation of the relationship between hazard and hazardous situation.

ISO 14971:2019

[SOURCE: ISO/IEC Guide 63:2019, 3.3, modified – Note 1 to entry added.]

Health institution

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

MDR (EU) 2017/745

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Implantable device

‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended:

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

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

Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device;

MDR (EU) 2017/745

Classification

Importer

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

MDR (EU) 2017/745

In vitro diagnostic medical device

‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:

1. concerning a physiological or pathological process or state;
2. concerning congenital physical or mental impairments;
3. concerning the predisposition to a medical condition or a disease;
4. to determine the safety and compatibility with potential recipients;
5. to predict treatment response or reactions;
6. to define or monitoring therapeutic measures.

Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;

IVDR (EU) 2017/746

In-vitro diagnostic regulation IVDR

Incident (IVDR (EU) 2017/746)

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

IVDR (EU) 2017/746

Incident (MDR (EU) 2017/745)

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

MDR (EU) 2017/745

Indication / Indication for use

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

MDCG 2020-6

Informed consent (IVDR (EU) 2017/746)

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

IVDR (EU) 2017/746

Informed consent (MDR (EU) 2017/745)

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

MDR (EU) 2017/745

Instruction for use

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

IVDR (EU) 2017/746

Intended purpose

‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation;

MDR (EU) 2017/745

Intended use

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

MDCG 2020-6

Intended use/intended purpose

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

Note 1 to entry: 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.

ISO 14971:2019

[SOURCE: ISO/IEC Guide 63:2019, 3.4]

Interoperability

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

1. 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
2. communicate with each other, and/or
3. work together as intended.

MDR (EU) 2017/745

Interventional clinical performance study

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

IVDR (EU) 2017/746

Invasive device

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

MDR (EU) 2017/745

Classification

Investigational device

‘investigational device’ means a device that is assessed in a clinical investigation;

MDR (EU) 2017/745

Investigator (IVDR (EU) 2017/746)

‘investigator’ means an individual responsible for the conduct of a performance study at a performance study site;

IVDR (EU) 2017/746

Investigator (MDR (EU) 2017/745)

‘investigator’ means an individual responsible for the conduct of a clinical investigation at a clinical investigation site;

MDR (EU) 2017/745

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Kit

‘kit’ means a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof;

IVDR (EU) 2017/746

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Label

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

MDR (EU) 2017/745

Lay person

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

MDR (EU) 2017/745

Legacy devices

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

MDCG 2020-6

Medical device directive

Level of clinical evidence

‘level of clinical evidence’: this terminology is used in the MDR with respect to requirements for demonstration of conformity with the relevant GSPR and overall benefit-risk14. It is understood to encompass the amount and quality of evidence (i.e. its characterisation by quality, quantity, completeness and statistical validity, etc.) required to demonstrate safety, performance and the benefit-risk conclusion of a medical device. It should not be confused with the term ‘levels of evidence’ (as used in evidence-based medicine) which is used to rank study designs, and is only a part of the concept ‘level of clinical evidence’. Regarding the assessment of the level of clinical evidence for the device in question, see sections 6.3 and 6.5d of this document.

MDCG 2020-6

Life cycle

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

ISO 14971:2019

[SOURCE: ISO/IEC Guide 63:2019, 3.5]

Likelihood ratio

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

IVDR (EU) 2017/746

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Making available on the market

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

MDR (EU) 2017/745

Manufacturer

‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark;

MDR (EU) 2017/745

Manufacturer

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 to entry: 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 to entry: 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 to entry: “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 to entry: 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 to entry: 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 to entry: 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 entry: 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.

ISO 14971:2019

[SOURCE: ISO/IEC Guide 63:2019, 3.6]

Market surveillance

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

MDR (EU) 2017/745

Medical device

‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
• investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
• providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The following products shall also be deemed to be medical devices:

• devices for the control or support of conception;
• products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

MDR (EU) 2017/745

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Nanomaterial

‘nanomaterial’ means a natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm;

Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall also be deemed to be nanomaterials;

MDR (EU) 2017/745

Negative predictive value

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

IVDR (EU) 2017/746

Non-viable

‘non-viable’ means having no potential for metabolism or multiplication;

MDR (EU) 2017/745

Notified body

‘notified body’ means a conformity assessment body designated in accordance with this Regulation;

MDR (EU) 2017/745

Notified bodies

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Objective Evidence

data supporting the existence or verity of something

Note 1 to entry: Objective evidence can be obtained through observation, measurement, test or by other means.

ISO 14971:2019

[SOURCE: ISO 9000:2015, 3.8.3, modified – Note 2 to entry deleted.]

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Particle

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

MDR (EU) 2017/745

Performance

‘performance’ means the ability of a device to achieve its intended purpose as stated by the manufacturer;

MDR (EU) 2017/745

Performance evaluation

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

IVDR (EU) 2017/746

Performance of a device

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

IVDR (EU) 2017/746

Performance study

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

IVDR (EU) 2017/746

Performance study plan

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

IVDR (EU) 2017/746

Placing on the market (IVDR (EU) 2017/746)

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

IVDR (EU) 2017/746

Placing on the market (MDR (EU) 2017/745)

‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market;

MDR (EU) 2017/745

Positive predictive value

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

IVDR (EU) 2017/746

Post-market surveillance

‘post-market surveillance’ 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;

IVDR (EU) 2017/746

Post-market surveillance

Post-production

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.

ISO 14971:2019

Predictive value

‘predictive value’ 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;

IVDR (EU) 2017/746

Procedure

specified way to carry out an activity or a process

Note 1 to entry: Procedures can be documented or not.

ISO 14971:2019

[SOURCE: ISO 9000:2015, 3.4.5]

Procedure pack

‘procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose;

MDR (EU) 2017/745

Process

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

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

Note 2 to entry: 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 to entry: Two or more interrelated and interacting processes in series can also be referred to as a process.

ISO 14971:2019

[SOURCE: ISO 9000:2015, 3.4.1, modified – Notes to entry 4, 5 and 6 are deleted.]

Putting into service (IVDR (EU) 2017/746)

‘putting into service’ means 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;

IVDR (EU) 2017/746

Putting into service (MDR (EU) 2017/745)

‘putting into service’ means 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;

MDR (EU) 2017/745

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Reasonably foreseeable misuse

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

Note 2 to entry: Reasonably foreseeable misuse can be intentional or unintentional.

ISO 14971:2019

[SOURCE: ISO/IEC Guide 63:2019, 3.8]

Recall

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

MDR (EU) 2017/745

Record

document stating results achieved or providing evidence of activities performed

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

Note 2 to entry: Generally records need not be under revision control.

ISO 14971:2019

[SOURCE: ISO 9000:2015, 3.8.10]

Reprocessing

‘reprocessing’ means 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;

MDR (EU) 2017/745

Residual risk

Risk remaining after risk control measures have been implemented

ISO 14971:2019

[SOURCE: ISO/IEC Guide 63:2019, 3.9]

Risk

‘risk’ means the combination of the probability of occurrence of harm and the severity of that harm;

MDR (EU) 2017/745

ISO 14971 and risk management

Risk analysis

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

ISO 14971:2019

[SOURCE: ISO/IEC Guide 63:2019, 3.11]

Risk assessment

Overall process comprising a risk analysis and a risk evaluation

ISO 14971:2019

[SOURCE: ISO/IEC Guide 51:2014, 3.11]

Risk control

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

ISO 14971:2019

[SOURCE: ISO/IEC Guide 63:2019, 3.12]

Risk estimation

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

ISO 14971:2019

[SOURCE: ISO/IEC Guide 63:2019, 3.13]

Risk evaluation

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

ISO 14971:2019

[SOURCE: ISO/IEC Guide 63:2019, 3.14]

Risk management

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

ISO 14971:2019

[SOURCE: ISO/IEC Guide 63:2019, 3.15]

Risk management file

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

ISO 14971:2019

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Safety

Freedom from unacceptable risk

ISO 14971:2019

[SOURCE: ISO/IEC Guide 63:2019, 3.10]

Scientific validity

‘scientific validity’, ‘scientifically valid’: this terminology is used in the MDR in reference to clinical data planning, evaluation and conclusions12. Clinical evaluations must follow a “defined and methodologically sound procedure”13, for which expectations of scientific validity are implicit. Embedded in the term ‘scientific validity’ are concepts including adequacy of study design and controls for bias, appropriateness and relevance of research questions, adequacy of sample sizes and statistical analyses, completeness of data, adequacy of follow up period, and appropriateness of conclusions on the basis of objective evidence.

Section 9.3.1 of MEDDEV 2.7/1 rev. 4 provides guidance for the evaluation of methodological quality and scientific validity under the MDD/AIMDD which are equally valid under the MDR which can be considered to apply when referencing ‘scientific validity’ in this guidance.

MDCG 2020-6

Medical device directive

MEDDEV 271

Scientific validity of an analyte

‘scientific validity of an analyte’ means the association of an analyte with a clinical condition or a physiological state;

IVDR (EU) 2017/746

Serious adverse event (IVDR (EU) 2017/746)

‘serious adverse event’ means any adverse event that led to any of the following:

1. 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,
2. death,
3. 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:

1. life-threatening illness or injury,
2. permanent impairment of a body structure or a body function,
3. hospitalisation or prolongation of patient hospitalisation,
4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
5. chronic disease,

1. foetal distress, foetal death or a congenital physical or mental impairment or birth defect;

IVDR (EU) 2017/746

Serious adverse event (MDR (EU) 2017/745)

‘serious adverse event’ means any adverse event that led to any of the following:

1.  death,
2. serious deterioration in the health of the subject, that resulted in any of the following:
   1. life-threatening illness or injury,
   2. permanent impairment of a body structure or a body function,
   3. hospitalisation or prolongation of patient hospitalisation,
   4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
   5. chronic disease,
3. foetal distress, foetal death or a congenital physical or mental impairment or birth defect;

MDR (EU) 2017/745

Serious incident

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

1. the death of a patient, user or other person,
2. the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
3. a serious public health threat;

MDR (EU) 2017/745

Serious public health threat

‘serious public health threat’ 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;

MDR (EU) 2017/745

Severity

Measure of the possible consequences of a hazard

ISO 14971:2019

[SOURCE: ISO/IEC Guide 63:2019, 3.17]

Similar device

‘similar device’: devices belonging to the same generic device group. The MDR (Article 2(7)) defines this as 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.

MDCG 2020-6

device group

Single-use device (IVDR (EU) 2017/746)

‘single-use device’ means a device that is intended to be used during a single procedure;

IVDR (EU) 2017/746

Single-use device (MDR (EU) 2017/745)

‘single-use device’ means a device that is intended to be used on one individual during a single procedure;

MDR (EU) 2017/745

Specimen receptacle

‘specimen receptacle’ means a 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;

IVDR (EU) 2017/746

Sponsor (IVDR (EU) 2017/746)

‘sponsor’ 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;

IVDR (EU) 2017/746

Sponsor (MDR (EU) 2017/745)

‘sponsor’ 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;

MDR (EU) 2017/745

State of the art

‘state of the art’: IMDRF/GRRP WG/N47 provides the following definition:

Developed stage of current technical capability and/or accepted clinical practice in regard to products, processes and patient management, 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

MDCG 2020-6

Subject (IVDR (EU) 2017/746)

‘subject’ 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;

IVDR (EU) 2017/746

Subject (MDR (EU) 2017/745)

‘subject’ means an individual who participates in a clinical investigation;

MDR (EU) 2017/745

System

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

MDR (EU) 2017/745

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Top management

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

ISO 14971:2019

[SOURCE: ISO 9000:2015, 3.1.1, modified — “An organization” replaced by “a manufacturer”, Notes to entry deleted.]

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Unique Device Identifier (‘UDI’)

‘Unique Device Identifier’ (‘UDI’) means 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;

MDR (EU) 2017/745

Unique device identification

Use error

than that intended by the manufacturer or expected by the user

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

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

Note 3 to entry: Users might be aware or unaware that a use error has occurred.

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

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

ISO 14971:2019

[SOURCE: IEC 62366-1:2015, 3.21, modified – Note 6 to entry deleted.]

User

‘user’ means any healthcare professional or lay person who uses a device;

MDR (EU) 2017/745

Usability & IEC 62366

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Verification

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

Note 1 to entry: 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 to entry: The activities carried out for verification are sometimes called a qualification process.

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

ISO 14971:2019

[SOURCE: ISO/IEC Guide 63:2019, 3.19]

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Well-established technology

‘well-established technology’: this terminology is used in Article 52(5) and Article 61(8) of the MDR, but is not defined in these articles. The term is not restricted to the devices listed in Article 61(6b); Article 61(8) explicitly states that this includes devices similar to the exempted devices listed in Article 61(6b), which might be added to that list in future. The common features of the devices which are well-established technologies are that they all have:

• relatively simple, common and stable designs with little evolution;
• their generic device group has well-known safety and has not been associated with safety issues in the past;
• well-known clinical performance characteristics and their generic device group are standard of care devices where there is little evolution in indications and the state of the art;
• a long history on the market.

Therefore, any devices that meet all these criteria may be considered “well-established technologies”.

MDCG 2020-6

Withdrawal

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

MDR (EU) 2017/745