Our glossary for guidance - Letter I

ICH stands for the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Its core business - bringing together regulatory authorities and the pharmaceutical industry in Europe, Japan and the USA - is to address the scientific and technical aspects of drug registration.

International Electrotechnical Commission

International Food Standard.

Shortcut for Instructions for Use.

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

Industriegewerkschaft Bauen-Agrar-Umwelt.

Mining, Chemical and Energy Workers' Union

Workers union for metal.

Chamber of Commerce and Industry

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]

Any device which is intended:

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

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

Any device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is also considered an implantable device.

[Definition according to (93/42/EEC) Annex IX No. 1.2]

‘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.

[Definition according to (EU) 2017/745 Article 2 No. 5]

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

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

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

[Definition under (EU) 2017/745 Article 2 No. 33 also corresponds to definition under (EU) 2017/746 Article 2 No. 26]

IMS is an abbreviation for an "integrated management system" that results from the combination of at least two or more individual management systems.

‘In vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, 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:

• concerning a physiological or pathological state, or
• concerning a congenital abnormality, or
• to determine the safety and compatibility with potential recipients, or
• to monitor therapeutic measures.

Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.

Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination.

[Definition according to (98/79/EC) Article 1 No. 2b]

‘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:

(a) concerning a physiological or pathological process or state;

(b) concerning congenital physical or mental impairments;

(c) concerning the predisposition to a medical condition or a disease;

(d) to determine the safety and compatibility with potential recipients;

(e) to predict treatment response or reactions;

(f) to define or monitoring therapeutic measures. Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices.

[Definition according to (EU) 2017/746 Article 2 No. 2].

‘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.

[Definition according to (EU) 2017/746 Article 2 No. 67]

‘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;

[Definition according to (EU) 2017/745 Article 2 No. 64]

Incoming goods inspection is the inspection of purchased raw materials and semi-finished products according to defined specifications.

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]

‘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.

[Definition according to (EU) 2017/746 Article 2 No. 58]

‘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.

[Definition according to (EU) 2017/745 Article 2 No. 55]

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]

‘Injured skin or mucous membrane’ means an area of skin or a mucous membrane presenting a pathological change or change following disease or a wound.

[Definition according to (EU) 2017/745 Annex VIII Chapter I No. 2.8]

’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.

[Definition under (EU) 2017/745 Article 2 No. 14 also corresponds to definition under (EU) 2017/746 Article 2 No. 14]

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]

'Intended purpose' means the use for which the medical device is intended and for which it is suited according to the data supplied by the manufacturer in the instructions.

[Definition according to (90/385/EEC) Article 1 No. 2f]

‘Intended purpose’ means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions for use and/or in promotional materials.

[Definition according to (98/79/EC) Article 1 No. 2h]

‘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 or as specified by the manufacturer in the performance evaluation.

[Definition according to (EU) 2017/746 Article 2 No. 12]

'Intended purpose' means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials.

[Definition according to (93/42/EEC) Article 1 No. 2g]

‘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.

[Definition according to (EU) 2017/745 Article 2 No. 12]

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]

1st party audit. The auditor is an employee of the same organization in which the audit is performed.

An internal auditor conducts a 1st party audit. The auditor is an employee of the same organization in which the audit is performed.

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

(a) exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data, and/or

(b) communicate with each other, and/or

(c) work together as intended.

[Definition under (EU) 2017/745 Article 2 No. 26 also corresponds to definition under (EU) 2017/746 Article 2 No. 19]

With the help of the interrelationship diagram, complex interrelationships can be represented more simply, but also integrated in networks. These serve the general planning of projects / interrelationships. With this representation it is quite easy to show the actual core and support processes and their interactions.

‘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.

[Definition according to (EU) 2017/746 Article 2 No. 46].

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]

‘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.

[Definition according to (EU) 2017/745 Article 2 No. 6]

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

[Definition according to (93/42/EEC) Annex IX No. 1.2]

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]

‘Investigational device’ means a device that is assessed in a clinical investigation.

[Definition according to (EU) 2017/745 Article 2 No. 46]

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

[Definition according to (EU) 2017/746 Article 2 No. 48]

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]

‘Investigator’ means an individual responsible for the conduct of a clinical investigation at a clinical investigation site.

[Definition according to (EU) 2017/745 Article 2 No. 54]

Input-Process-Output diagram

The International Register of Certificated Auditors is an auditor certification body that maintains a pool of qualified, certified and independent auditors.

The Ishikawa diagram is one of the best-known tools for identifying the cause of an error in a categorised way. In the meantime, Ishikawa uses the 7Ms (man, machine, method, material, measurement, environment, management) and takes into account their contributions to the problem.

International Organization for Standardization

International Telecommunications Union

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]

EU In Vitro Diagnostic Medical Devices Regulation: (EU) 2017/746.

On 26 May 2017, this EU regulation became binding in all EU member states and replaces the currently valid EU directive within the transition period of five years. The IVDD (98/79/EC) was replaced by the IVDR (2017/746 EU) on 26 May 2022.