Our glossary for guidance - Letter E

‘Economic operator’ means a manufacturer, an authorised representative, an importer or a distributor.

[Definition according to (EU) 2017/746 Article 2 No. 28]

‘Economic operator’ means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3).

[Definition according to (EU) 2017/745 Article 2 No. 35]

The effective and efficient implementation of a measure

Effectiveness is a measure of goal achievement (effectiveness, quality of goal achievement, etc.) and emphasises the operational side of the use of resources.

Control question: "Are the right things being done"?

Efficiency is a measure of cost-effectiveness (cost-benefit reaction) and emphasises the economic side of the use of resources.

Control question: "Are things being done right"?

The EFQM model is a quality management system of total quality management and was developed by the EFQM. This model aims at successful business management (Business Excellence), which enables a holistic view of organisations.

The "eh da costs" are a funny reference to costs that are not taken into account in the calculation, as they are incurred anyway.

The EKUV analysis stands for "Eliminate, Combine, Convert, Simplify" and is an analysis that is used for set-up time optimisation (see also SMED). It is a systematic approach to drastically reduce set-up time.

EMA is the abbreviation for the European Medicines Agency. It is a specialised agency of the European Union for human, veterinary and herbal medicinal products for human use.

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]

The employee suggestion scheme is part of idea management and is an employee-involving (participative) optimisation system with the aim of using the suggestions and ideas of all employees within an organisation for its benefit.

Employer's Liability Insurance Association (german: Berufsgenossenschaften, BG) are self-governing bodies according to §31 SGB IV. Since 01.01.2011 there have been nine industrial trade associations:

• BG Bau (construction)
• BGHW
• BG ETEM
• VBG
• BG RCI
• BG Verkehr (transport)
• BGN
• BGHM
• BGW

European standards are standards from one of the three European committees

• CEN; Committee for Standardisation
• ETSI; Committee for Telecommunications Standards
• CENELEC; Committee for Electrotechnical Standardisation

EPEI is an acronym for "Every Part Every Interval" and describes a key figure that provides information on whether all products can be manufactured and set up within the desired time interval.

‘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.

[Definition under (EU) 2017/745 Article 2 No. 56 also corresponds to definition under (EU) 2017/746 Article 2 No. 59]

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 Databank on Medical Devices

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]

Railway and Transport Union.

An external auditor conducts a 3rd party audit. The auditor is an employee of an independent body.