Our glossary for guidance - Letter M

‘Making available on the market’ means any supply of a device, other than a device for performance study, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.

[Definition according to (EU) 2017/746 Article 2 No. 20]

‘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.

[Definition according to (EU) 2017/745 Article 2 No. 27]

Management processes include all processes for leading and controlling the company (e.g. policy, goals, programmes, delegation, auditing, internal communication, etc.).

The management representative (formerly also BdOL: Superior Performance Officer) is the appointed officer or a staff position within an organisation and reports to the management and its internal service providers and advisors for the respective management system.

The new seven management tools "M7" (or also called "N7") are composed of the following methods:

• Affinity diagram
• Interrelationship diagram
• Tree diagram
• Matrix diagram
• Portfolio
• Network diagram
• Decision tree

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]

‘Manufacturer’ means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.

The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as devices with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient.

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

'Manufacturer' means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party. The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient.

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

‘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.

[Definition under (EU) 2017/745 Article 2 No. 30 also corresponds to definition under (EU) 2017/746 Article 2 No. 23]

Association of Salaried and Civil Servant Doctors in Germany.

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]
 

‘Market surveillance’ means the activities carried out and measures taken by public 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.

[Definition according to (EU) 2017/746 Article 2 No. 64]

‘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.

[Definition according to (EU) 2017/745 Article 2 No. 61]

Within a matrix diagram, relationships and interactions of two different groups of characteristics are represented and evaluated.

Most Advanced Yet Acceptable - as complex as just acceptable.

Management by Facts.

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]

Short for Medical Device Single Audit Program

The MDSAP is a program for simplified audits and easier access to the markets of participating countries. However, national regulations take precedence. Participating countries are the U.S., Japan, Canada, Brazil and Australia. Argentina, South Korea and Singapore are listed as affiliate members. Observers are the EU, the UK and the WHO.

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]
 

The measurements made by devices with a measuring function shall be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC.

[Definition according to (EU) 2017/745 Article 1, Chapter 2, point 15.2. no. 39]

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]

MedDRA is a medical dictionary for proper activities and is operated by ICH.

'Medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be used for human beings in the:

• diagnosis, prevention, monitoring, treatment or alleviation of disease or injury,
• investigation, replacement or modification of the anatomy or of a physiological process,
• control of conception, and which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means, but which may be assisted in its function by such means.

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

‘Medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap,
• investigation, replacement or modification of the anatomy or of a physiological process,
• control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

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

'Medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
• investigation, replacement or modification of the anatomy or of a physiological process,
• control of. conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

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

‘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.

[Definition under (EU) 2017/745 Article 2 No. 1 also corresponds to definition under (EU) 2017/746 Article 2 No. 1]

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]

All active substances and combinations of active substances intended for medical diagnosis, therapy or prophylaxis, or which influence physiological functions. The term goes beyond that of medication, as it also includes contrast media and the like.

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]

This is the term used to describe interim goals in project management.

According to the British mental trainer Tony Buzan, a method that branches out from the starting point further and further into individual ideas and tasks. Individual topics can be identified by different colour codes.

Minitab is a statistical software whose field of application is strongly influenced by Six Sigma.

MINT is a acronym for mathematics, computer science, natural science and technology; in german: Mathematik, Informatik, Naturwissenschaft und Technik.

MS is an abbreviation for a management system.

Shortcut for Member State.

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

Measurement system analysis.

Mean time before failure, average life span.

Mean time to failure, average life span for non-repairable parts, e.g. flash lamps.