Our glossary for guidance - Category MDCG

The term ‘Absorption’ in the context of implantable devices refers to the degradation of a material within the body and the metabolic elimination of the resulting degradation products from the body. It does not apply to those substances that are excreted without modification from the body, e.g. insufflation gases for the abdominal cavity or laparoscopic and endoscopic procedures.

[Definition of term as defined in MDCG 2021-24 No. 3.1.8]

The concept act by converting energy includes conversion of energy in the device and/or conversion at the interface between the device and the tissues or in the tissues. Electrodes intended for E.C.G. or E.E.G are normally not considered active devices because they do not normally act by conversion of energy.

[Definition of term as defined in MDCG 2021-24 No. 3.1.5]

Active device intended for diagnosis and monitoring means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities. A device is considered to allow direct diagnosis when it provides the diagnosis of the disease or condition in question itself or when it provides decisive information for the diagnosis.

[Definition of term as defined in MDCG 2021-24 No. 3.1.5]

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.

[Definition of term as defined in MDCG 2021-24 No. 3.1.5]

Active therapeutic device means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability.

[Definition of term as defined in MDCG 2021-24 No. 3.1.5]

An Actor ID is the identifier issued to all actors registered in EUDAMED for their identification in the system. It will be automatically generated by EUDAMED and issued once the registration request is approved by the relevant competent authority.

[Definition according to MDCG 2021-13 rev.1 Terminology]

Adverse Event (AE)
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 Article 2(57))
Note:
a. This definition includes events that are anticipated as well as unanticipated events
b. This definition includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.

[Definition of the term according to MDCG 2020-10/1]

Are designed for use during anaesthesia with an anaesthetic breathing system (See e.g. EN ISO 80601-2-13:2012). Ventilators for critical care are usually invasive, which enables the ventilator machine to provide lung support for inspiration and expiration through tracheal intubation. However, most critical care ventilators allow non-invasive ventilation modes for critical care patients as well. Ventilators for non-critical care are usually non-invasive and therefore provide air pressure support to natural breathing through e.g. a facemask. Ventilators may offer different types of additional complementary functions that include:

• High flow oxygen supply (nasal high flow therapy);
• Monitoring systems;
• Nebulisation systems.

[Definition according to MDCG 2020-9 No. 2.1]

A substance or material; something that identifies or that is used to identify; a factor that establishes the nature of an entity or event; constituent of a sample with a measurable property.

[Definition according to MDCG 2020-16 rev.1 No. 2]
 

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

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 40]

The capability of the method to distinguish between two close concentrations of the target marker/analyte.
Source: Iteration from several sources

[Definition according to MDCG 2022-2 No. 4]

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.
Source: Iteration from several sources

[Definition according to MDCG 2022-2 No. 4]

an organisation that legally represents a manufacturer in the EU, when the manufacturer is based outside the EU.

[Definition according to COVID-19 IVD-QA Abbreviations and Terms]

A defined amount of material, either starting material, intermediate or finished product which is uniform in its properties and has been produced in one process or series of processes.
[vgl. EN 13975:2003]

[Definition according to MDCG 2022-3 No. 3.2]

Any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.

[Definition of term as defined in MDCG 2021-24 No. 3.1.4]

Symbol “CE” marked on the product, demonstrating that the product satisfies the applicable EU requirements.

[Definition according to COVID-19 IVD-QA Abbreviations and Terms]

CE Marking on a product to signify that it meets the legal requirements to be sold on the extended Single Market in the European Economic Area (EEA).

[Definition of the term according to MDCG 2021-6 Abbreviations]

Shortcut for Clinical Evaluation Assessment Report.

[Definition of the term according to MDCG 2020-13 Acronyms]

Shortcut for Clinical Evaluation Consultation Procedure.

[Definition of the term according to MDCG 2020-13 Acronyms]

Central circulatory system means the following blood vessels:

• arteriae pulmonales
• arteriae cerebrales
• truncus brachiocephalicus
• aorta ascendens
• aorta descendens bis zur bifurcatio aortae
• arteriae coronariae
• venae pulmonales
• vena cava superior
• arteria carotis communis
• arteria carotis externa
• arcus aortae
• arteria carotis interna
• venae cordis
• vena cava inferior

[Definition of term as defined in MDCG 2021-24 No. 3.1.4]

Central nervous system means the brain, meninges and spinal cord.

[Definition of term as defined in MDCG 2021-24 No. 3.1.4]

Shortcut for Clinical Evaluation Report.

[Definition of the term according to MDCG 2020-13 Acronyms]

Reference material, accompanied by a certificate, one or more whose property values are certified by a procedure which establishes its traceability to an accurate realization of the unit in which the property values are expressed, and for which each certified value is accompanied by an uncertainty at a stated level of confidence.

[Definition according to MDCG 2022-2 No. 4, also corresponds to WHO TGS-8 definition: Quality control for in vitro diagnostic medical devices for WHO prequalification]

Measurement method which has been certified to show appropriate trueness and precision for its intended purpose and has been officially defined as reference method by a competent body.

[Definition according to MDCG 2022-2 No. 4, also corresponds to WHO TGS-8 definition: Quality control for in vitro diagnostic medical devices for WHO prequalification]

Shortcut for Clinical Investigation Plan.

[Definition of term as per MDCG 2021-6 Abbreviations and MDCG 2020-13 Acronyms]

Clinical investigation identification number, generated by Eudamed for clinical investigations under the Medical Device Directives.

[Definition of terms according to MDCG 2019-9 Abbreviations]

Devices intended to be used for blood grouping, or to determine foeto-maternal blood group incompatibility, or for tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration, are classified as class C, except when intended to determine any of the following markers:

• ABO system [A (ABO1), B (ABO2), AB (ABO3)];
• Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)];
• Kell system [Kel1 (K)];
• Kidd system [JK1 (Jka), JK2 (Jkb)];
• Duffy system [FY1 (Fya), FY2 (Fyb)]

Note: Please see MDCG 2020-167 (Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746) for examples of devices falling in Class D.

[Definition according to MDCG 2022-3 No. 3.1, also corresponds to definition under (EU) 2017/746 Annex VIII Section 2 Rule 2]

The IVDR refers to class D devices in rules 1 and 2 of Annex VIII as follows: Devices intended to be used for the following purposes are classified as class D:

• detection of the presence of, or exposure to, a transmissible agent in blood, blood components, cells, tissues or organs, or in any of their derivatives, in order to assess their suitability for transfusion, transplantation or cell administration;
• detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation;
• determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management.

[Definition according to MDCG 2022-3 No. 3.1, also complies to definition under (EU) 2017/746 Article 47(I) & Annex VIII Section 2 Rule 1]

The positive impact of a device related to its function, such as that of screening, monitoring, diagnosis or aid to diagnosis of patients, or a positive impact on patient management or public health.

Note: It should be recognized that the concept of clinical benefit for in vitro diagnostic medical devices is fundamentally different from that which applies in the case of pharmaceuticals or of therapeutic medical devices, since the benefit of in vitro diagnostic medical devices lies in providing accurate medical information on patients, where appropriate, assessed against medical information obtained through the use of other diagnostic options and technologies, whereas the final clinical outcome for the patient is dependent on further diagnostic and/or therapeutic options which could be available.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 (37) and recital 64]

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

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 36]

The ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 41] ]

Carcinogenic, Mutagenic or toxic to Reproduction.

[Definition of terms according to MDCG 2019-9 Abbreviations]

A set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.

[Definition according to MDCG 2022-3 No. 3.3, also corresponds to definition under (EU) 2017/746 Article 2 No. 74]

a government body that implements and enforces legislation, in this case in the field of in vitro diagnostic medical devices.

[Definition according to COVID-19 IVD-QA Abbreviations and Terms]

Is a device intended to be used for the confirmation of a reactive result from a first line assay.

[Definition according to MDCG 2020-16 rev.1 No. 2]

shortcut for ‘common specifications’ as defined in the MDR.

[Definition of terms according to MDCG 2019-9 Abbreviations]

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

[Definition of term as defined in MDCG 2021-24 No. 3.1.8]

Means the indirect detection of an agent (present or past exposure). By detecting the presence of surrogate markers, such as antibodies against components of the agent.

[Definition according to MDCG 2020-16 rev.1 No. 2]

Means the direct detection of the agent, by detecting

• the presence of the agent itself (e.g. bacterial, viral, fungal, parasitic, protozoal agents), or
• the presence of structural components derived from the agent, such as antigens or nucleic acids.

[Definition according to MDCG 2020-16 rev.1 No. 2]

Any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer.

[Definition of the term according to MDCG 2020-10/1, also corresponds to definition under (EU) 2017/745 Article 2 No. 59]

A device intended by the manufacturer to be used in a performance study.
A device intended to be used for research purposes, without any medical objective, shall not be deemed to be a device for performance study.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 45]

Are used for the measurement of the analyte (measurand) levels for the purpose of adjusting treatments/interventions as required. Devices for monitoring include the following:

• Devices which are used to assess whether an analyte remains within physiological levels or within an established therapeutic drug range. These types of devices are designed to evaluate an individual’s current state.
• Devices which are used for serial measurement, whereby multiple determinations are taken over time. These types of devices are typically used for the detection/assessment of disease progression/regression, disease recurrence, minimum residual disease, response/resistance to therapy, and/or adverse effects due to therapy. These types of devices are designed to evaluate changes in an individual’s state.

[Definition according to MDCG 2020-16 rev.1 No. 2]

Are used to detect the presence of or the predisposition to a disease, disorder or other physiological state in a specimen from an individual, embryo or foetus not demonstrating clinically evident symptoms. Depending on the nature of the condition and the targeted patient population, screening devices may be used routinely or may be restricted to "at risk" patients. This also includes (for example) devices intended to assess the suitability of blood, blood components, cells, tissues or organs, or in any of their derivatives for transfusion, transplantation or cell administration, with respect to transmissible agents.

[Definition according to MDCG 2020-16 rev.1 No. 2]

Means any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services.

[Definition according to MDCG 2020-16 rev.1 No. 2]

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

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 50]

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

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 49]

a natural or legal person making devices available in the Union, other than the manufacturer or the importer.

[Definition according to COVID-19 IVD-QA Abbreviations and Terms]

An unborn refers to stages in human development after zygote formation. A zygote is considered an embryo in particular from the period of conception to approximately the eighth week, and considered a foetus following this period until birth.
Samples from the embryo or foetus include samples from the embryonic/foetal membranes, fluids and excretions, the umbilical cord, and maternal samples (e.g. blood) containing embryonic/foetal material to be examined.

[Definition according to MDCG 2020-16 rev.1 No. 2]

A European Union reference laboratory designated according to Article 100 of the IVDR.

[Definition according to MDCG 2022-3 No. 3.4]

European Union.

[Definition of terms according to MDCG 2019-9 Abbreviations]

European database on medical devices.

[Definition of term as per MDCG 2021-08 Acronyms, MDCG 2021-28 Acronyms, MDCG 2020-13 Acronyms and MDCG 2019-9 Abbreviations]

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

[Definition according to MDCG 2022-2 No. 4]

Is a device intended to be used to detect a marker or analyte  and which may be followed by a confirmatory assay. Devices intended to be used solely to monitor a previously determined marker or analyte are not considered first-line assays.

[Definition according to MDCG 2020-16 rev.1 No. 2]

An unborn refers to stages in human development after zygote formation. A zygote is considered an embryo in particular from the period of conception to approximately the eighth week, and considered a foetus following this period until birth.
Samples from the embryo or foetus include samples from the embryonic/foetal membranes, fluids and excretions, the umbilical cord, and maternal samples (e.g. blood) containing embryonic/foetal material to be examined.

[Definition according to MDCG 2020-16 rev.1 No. 2]

Shortcut for Field Safety Corrective Action.

[Definition of terms according to MDCG 2019-9 Abbreviations]

Shortcut for Field Safety Notice.

[Definition of terms according to MDCG 2019-9 Abbreviations]

Shortcut for General safety and performance requirements.

[Definition of the term according to MDCG 2021-28 Acronyms]

Intended for use in the home healthcare environment; intended for use by a lay operator; intended for use with patients who are dependent on mechanical ventilation for their life support. Depending on the intended purpose can be also used in the clinical setting (See e.g. EN ISO 80601-2-72:2015).

[Definition according to MDCG 2020-9 No. 2.1]

Shortcut for Instructions for Use.

[Definition of terms according to MDCG 2020-13 Acronyms and MDCG 2019-9 Abbreviations]

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.

[Definition of term as defined in MDCG 2021-24 No. 3.1.4]

a natural or legal person importing devices into the EU from outside the Union.

[Definition according to COVID-19 IVD-QA Abbreviations and Terms]

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).

[Definition according to MDCG 2020-6 No. 1.2]

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).

[Definition according to MDCG 2020-6 No. 1.2]

Is an agent capable of producing infection. This includes iatrogenic infections, i.e. those infections transmitted during medical treatment and care.

[Definition according to MDCG 2020-16 rev.1 No. 2]

Is an agent capable of producing infection. This includes iatrogenic infections, i.e. those infections transmitted during medical treatment and care.

[Definition according to MDCG 2020-16 rev.1 No. 2]

An area of skin or a mucous membrane presenting a pathological change or change following disease, a wound or a scar.

[Definition of term as defined in MDCG 2021-24 No. 3.1.4]

Means equipment or apparatus intended by a manufacturer to be used as an IVD medical device.

[Definition according to MDCG 2020-16 rev.1 No. 2]

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

[Definition according to MDCG 2020-6 No. 1.2]

Any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body. A device that administers energy to the body should not be considered as invasive if only energy it emits penetrates the body and not the device itself.

[Definition of term as defined in MDCG 2021-24 No. 3.1.4]

A device that is assessed in a clinical investigation.

Note: An investigational device can be a non-CE marked device or a CE marked device. The definition in MDR Article 2(46) does not differentiate between different regulatory statuses of devices. However, the reporting requirements are different depending on whether the clinical investigation is done for purposes described in Article 62, 74 or 82. The definition is understood to cover also the devices investigated in PMCF investigations, even if they are not subject to notification per Art 74.1.

[Definition of the term according to MDCG 2020-10/1, also corresponds to definition under (EU) 2017/746 Article 2 No. 46]

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

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 48]

In vitro diagnostic medical device, a medical device intended by the manufacturer for the in vitro examination of specimens derived from the human body for a medical purpose.

[Definition according to COVID-19 IVD-QA Abbreviations and Terms]

‘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).

[Definition according to MDCG 2020-6 No. 1.2]

This guidance follows the approach set out in Guidance MDCG 2019-52 according to which ‘legacy devices’ should be understood as devices, which, in accordance with Article 120(3) MDR and Article 110(3) IVDR, are placed on the market after MDR or IVDR dates of application respectively and until 26 May 2024, or until the relevant certificate becomes void, if certain conditions are fulfilled.

• devices which are class I devices under Directive 93/42/EEC, for which a declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body;
• devices covered by a valid certificate issued in accordance with Directives 90/385/EEC or 93/42/EEC prior to 26 May 2021;
• devices covered by a valid certificate issued in accordance with Directive 98/79/EC prior to 26 May 2022.

[Definition according to MDCG 2021-13 rev.1 Terminology]

‘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-risk. 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.

[Definition according to MDCG 2020-6 No. 1.2]

Are diseases, conditions or situations that in general result in death. These are often untreatable, treatment options are limited or require major medical interventions.

[Definition according to MDCG 2020-16 rev.1 No. 2]

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.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 54]

The ability to provide measured quantity values that are directly proportional to the value of the measurand in the sample.
Source: ISO 18113-1

[Definition according to MDCG 2022-2 No. 4]

The condition by which substances remain in a specific site without being distributed into the body via the blood and/or lymphatic system.

[Definition of term as defined in MDCG 2021-24 No. 3.1.8]

Normally intended for continuous use for more than 30 days.

[Definition of term as defined in MDCG 2021-24 No. 3.1.2]

natural or legal person responsible for the production, packaging and labelling of the device before it is placed on the market in their own name.

[Definition according to COVID-19 IVD-QA Abbreviations and Terms]

A substance or material; something that identifies or that is used to identify; a factor that establishes the nature of an entity or event; constituent of a sample with a measurable property.

[Definition according to MDCG 2020-16 rev.1 No. 2]
 

Shortcut for Medical Device Coordination Group.

[Definition of the term according to MDCG 2021-6 Abbreviations]

Shortcut for Medical Device Regulation, referring to Regulation (EU) 2017/745 on medical devices.

[Definition of terms as per MDCG 2021-6 Abbreviations, MDCG 2020-13 Acronyms and MDCG 2019-9 Abbreviations]

Shortcut for Medical Device Software. 

[Definition according to MDCG 2021]

A substance or material; something that identifies or that is used to identify; a factor that establishes the nature of an entity or event; constituent of a sample with a measurable property.

[Definition according to MDCG 2020-16 rev.1 No. 2]
 

A 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
Source: International vocabulary of metrology – Basic and general concepts and associated terms (VIM) 3rd edition

[Definition according to MDCG 2022-2 No. 4]

Medical devices using prestored gases and/or vacuum as a power source are regarded as active devices, as long as they fulfil both the criteria under the definition e.g. gas mixers with anaesthesia machines, aerosol pain relief sprays with a pre-stored propellant gas supply and gas-powered suction pumps.

Heating/cooling pads intended only to release stored thermal energy are not active devices because they do not act by conversion of energy. However, heating/cooling pads which act by chemical action (e.g. exothermic or endothermic reaction) are active devices as they are converting chemical energy into heat and/or vice versa.

[Definition of term as defined in MDCG 2021-24 No. 3.1.5]

According to the definition given in Directive 2001/83/EC:
‘(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.’

[Definition of term as defined in MDCG 2021-24 No. 3.1.8]

According to the definition given in Directive 2001/83/EC:
‘(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.’

[Definition of term as defined in MDCG 2021-24 No. 3.1.8]

Property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty. The metrological traceability chain is a sequence of measurement standards and calibrations that is used to relate a measurement result to a reference. Source: International vocabulary of metrology – Basic and general concepts and associated terms (VIM) 3rd edition

[Definition according to MDCG 2022-2 No. 4]

Shortcut for Member State.

[Definition of the term according to MDCG 2021-6 Abbreviations]

A ‘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 according to MDR, Article 2(18). Related definitions on ‘particle’, ‘agglomerate’ and ‘aggregate’ are also included in the MDR Article 2(19-21). The definitions on nanomaterial and the related terms were taken from Commission Recommendation 2011/696/EU on the definition of nanomaterials23. Guidance on terms and concepts used in the definition can be found in a report from the European Commission’s Joint Research Centre.

[Definition of term as defined in MDCG 2021-24 No. 3.1.8]

Shortcut for Notified Body.

[Definition of terms according to MDCG 2019-9 Abbreviations]

Shortcut for National Competent Authority.

[Definition of term as per MDCG 2021-08 Acronyms and MDCG 2021-28 Acronyms]

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

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 53]

A newborn, or neonate, refers to an infant in the first 28 days after birth.

[Definition according to MDCG 2020-16 rev.1 No. 2]
 

an organisation that issues certificates to manufacturers, demonstrating that the manufacturer has fulfilled certain legal requirements.

[Definition according to COVID-19 IVD-QA Abbreviations and Terms]

Is the result of conception, at all stages of development, embryo and foetus, premature and full term neonates, child and adult.

[Definition according to MDCG 2020-16 rev.1 No. 2]

Devices placed on the market according to the medical devices Directives or the in vitro diagnostic medical devices Directive before the date of application of the MDR and IVDR or placed on the market before the Directives entered into force.

[Definition according to MDCG 2021-13 rev.1 Terminology]

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

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 44]

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.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 39]

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

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 43]

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

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 42]

Shortcut for Post-Market Clinical Follow-up.

[Definition of terms according to MDCG 2021-6 Abbreviations, MDCG 2021-08 Acronyms, MDCG 2021-28 Acronyms, MDCG 2020-13 Acronyms and MDCG 2019-9 Abbreviations]

Shortcut for Post-Market-Surveillance

[Definition of terms according to MDCG 2020-13 Acronyms and MDCG 2019-9 Abbreviations]

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

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 52]

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.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 51]

A 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. 

[Definition of term as defined in MDCG 2021-24 No. 3.1.7]

Shortcut for Post-Market Surveillance Update Report.

[Definition of terms according to MDCG 2020-13 Acronyms and MDCG 2019-9 Abbreviations]

Shortcut for Research Ethics Committee.

[Definition of term as per MDCG 2021-08 Acronyms and MDCG 2021-28 Acronyms]

An instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out.

[Definition of term as defined in MDCG 2021-24 No. 3.1.4, also corresponds to definition under (EU) 2017/745 Annex VIII 2.3]

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

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 16]

The robustness of an analytical procedure means the capacity of an analytical procedure to remain unaffected by small but deliberate variations in method parameters and provides an indication of its reliability during normal usage.
Source: ICH Q2(R1)– Validation of analytical procedures

[Definition according to MDCG 2022-2 No. 4]

Shortcut for Serious Adverse Event

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

[Definition of the term according to MDCG 2020-10/1, entspricht auch Begriffsdefinition gemäß (EU) 2017/745 Artikel 2 Nr. 58]

One or more units of product, either components or finished devices, drawn from a batch without regard to the quality of the units [refer to EN 13975:2003]

[Definition according to MDCG 2022-3 No. 3.6]

The association of an analyte with a clinical condition or a physiological state.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 2 No. 38]

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.

[Definition according to MDCG 2020-6 No. 1.2]

device intended by the manufacturer to be used by lay persons in a home environment.

[Definition according to COVID-19 IVD-QA Abbreviations and Terms]

Normally intended for continuous use for between 60 minutes and 30 days.

[Definition of term as defined in MDCG 2021-24 No. 3.1.2]

The concept of significant change for energy includes changes in the nature, level and density of energy (see Rule 9). This means that for instance an electrode is not considered an active device under this classification system as long as the energy input is intended to be the same as the energy output. Resistance in a wire that causes minor changes between input and output cannot be considered to constitute ‘significant change’. However, electrodes used in electrosurgery for cutting tissues or cauterisation are active devices because their operation depends on energy provided by a generator and their action is achieved by conversion of energy at the interface between the device and the tissue or in the tissue.

[Definition of term as defined in MDCG 2021-24 No. 3.1.5]

devices belonging to the same generic device group. The MDR 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.

[Definition according to MDCG 2020-6 No. 1.2]

Software is also an active device. Software should be reviewed not only in the context of Rule 11.

[Definition of term as defined in MDCG 2021-24 No. 3.1.5]

Is a discrete portion of a body fluid or tissue taken from an individual for examination, study or analysis of one or more quantities or characteristics to determine the character of the whole. This also includes other materials, for example, hair, nails excretions, secretions, or a sample from the skin surface.

[Definition according to MDCG 2020-16 rev.1 No. 2]

Is a discrete portion of a body fluid or tissue taken from an individual for examination, study or analysis of one or more quantities or characteristics to determine the character of the whole. This also includes other materials, for example, hair, nails excretions, secretions, or a sample from the skin surface.

[Definition according to MDCG 2022-2 No. 4]

Small portion of a body fluid or tissue taken from an individual for examination, study or analysis of one or more quantities or characteristics to determine the character of the whole.

[Definition according to MDCG 2022-3 No. 3.7]

Shortcut for Single Registration Number.

[Definition of terms according to MDCG 2020-13 Acronyms and MDCG 2019-9 Abbreviations]

A SRN is the Single Registration Number that is issued through EUDAMED to manufacturers, authorised representatives and importers by the competent authority in accordance with Article 31 MDR and 28 IVDR.

[Definition according to MDCG 2021-13 rev.1 Terminology]

Shortcut for Summary of Safety and Clinical Performance.

[Definition of terms according to MDCG 2020-13 Acronyms and MDCG 2019-9 Abbreviations]

Reference material, accompanied by a certificate, one or more whose property values are certified by a procedure which establishes its traceability to an accurate realization of the unit in which the property values are expressed, and for which each certified value is accompanied by an uncertainty at a stated level of confidence.

[Definition according to MDCG 2022-2 No. 4, also corresponds to WHO TGS-8 definition: Quality control for in vitro diagnostic medical devices for WHO prequalification]

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-ofthe-art“.

[Definition according to MDCG 2020-6 No. 1.2]

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” Source: Modified from IMDRF/GRRP WG/N47 FINAL:2018

[Definition according to MDCG 2022-2 No. 4]

Article 29 specifies the information, including data on performance evaluation and respective conclusions, which manufacturers have to provide to notified bodies for validation and to make available to the public in the “Summary of safety and performance” in the EUDAMED database.

[Definition according to MDCG 2022-2 No. 4, also corresponds to definition under (EU) 2017/746 Article 29]

An invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; and a device which produces penetration other than through a body orifice.
The term surgical operation used in this definition includes all clinical interventional procedures in which a device is placed into the body through the surface of the body. A surgically invasive device always implies that it enters through an artificially created opening. This can be a large opening, such as a surgical incision, or it can be a pinprick opening made by a needle. Therefore surgical gloves and needles used with syringes are surgically invasive.
In this context the following should be noted:

• a surgically created stoma used in urostomy, colostomy and ileostomy or permanent tracheostomy is considered to be a body orifice; therefore devices introduced into such a stoma are not surgically invasive.
• in contrast, a surgically created opening to allow access to the circulatory system should not be considered to be a body orifice. Devices introduced into such an opening are surgically invasive.

The concept of surgically invasive should be understood to cover also liquids that are in invasive contact with organs, tissues or other parts of the body if the access for such liquids is through a surgically created opening.
For a device that administers a substance, such a substance must be assessed in its own right (e.g. substances administered by a jet injector).

[Definition of term as defined in MDCG 2021-24 No. 3.1.4]

A system means a combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose.

[Definition of term as defined in MDCG 2021-24 No. 3.1.7]

The process by which substances or their metabolites enter the body (e.g. by crossing mucous membranes) and are distributed into the body via the blood and/or lymphatic system.

[Definition of term as defined in MDCG 2021-24 No. 3.1.8]

Shortcut für Technical Documentation.

[Definition of terms according to MDCG 2019-9 Abbreviations]

Shortcut for Technical Documentation Assessment Report.

[Definition of the term according to MDCG 2020-13 Acronyms]

Normally intended for continuous use for less than 60 minutes.

[Definition of term as defined in MDCG 2021-24 No. 3.1.2]

Means a biological substance or entity capable of causing disease or infection in individuals through individual to individual, animal to individual, or other modes of contact.

[Definition according to MDCG 2020-16 rev.1 No. 2]

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

[Definition according to MDCG 2022-2 No. 4]

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

[Definition according to MDCG 2022-2 No. 4]

Shortcut for Unique Device Identification Device Identifier.

[Definition of terms according to MDCG 2020-13 Acronyms and MDCG 2019-9 Abbreviations]

Shortcut for Uniform Resource Locator = internet address

[Definition of terms according to MDCG 2019-9 Abbreviations]

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.
Source: Modified from IEC 62366

[Definition according to MDCG 2022-2 No. 4]

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

Note 1 to entry: all aspects of usability, including effectiveness, efficiency and user satisfaction, can either increase or decrease safety. Source: IEC 62366:2015

[Definition according to MDCG 2022-2 No. 4]

Actual conditions and setting in which users interact with the IVDs (e.g. self-tests).

[Definition according to MDCG 2022-2 No. 4]

Automatic equipment that is intended to augment or provide ventilation of the lungs of the patient when connected to the airway of the patient:

• intended for use in an environment that provides specialized care for patients whose conditions can be life threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;
• intended to be operated by a healthcare professional operator; and
• intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.

See e.g. EN ISO/IEC 80601-2-12:2011 + Cor.:2011

[Definition according to MDCG 2020-9 No. 2.1]

These ventilators are used in Emergency Medical Service environment, e.g. in ambulances, transport of patients to the hospital, patient transport from hospital to hospital or transport within the hospital. The alarm and safety concept of emergency and transport ventilators in general is designed for a permanent presence of the user. This facilitates fast recognition and response in the event of an alarm or in the event of any malfunction (See e.g. EN 794-3:1998+A2:2009).

[Definition according to MDCG 2020-9 No. 2.1]

Ventilators are breathing support devices and can fall into different types according to their intended use and characteristics.

[Definition according to MDCG 2020-9 No. 2.1]

Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. [refer to EN ISO 9000:2015]

[Definition according to MDCG 2022-3 No. 3.5]

’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 wellestablished 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 “Wellestablished technologies”.

[Definition according to MDCG 2020-6 No. 1.2]

WHO provided international standard for the calibration and validation of diagnostic and screening assays.

[Definition according to MDCG 2022-2 No. 4]