Our glossary for guidance - Letter L

’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.

[Definition under (EU) 2017/745 Article 2 No. 13 also corresponds to definition under (EU) 2017/746 Article 2 No. 13]

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

[Definition under (EU) 2017/745 Article 2 No. 38 also corresponds to definition under (EU) 2017/746 Article 2 No. 31]

Term from the MIT study in 1990 (second industrial revolution).

It is a corporate philosophy that is intended to increase the competitiveness of the organisation within the framework of a holistic approach.

Initial analysis (also potential analysis), which often uses LEAN accounting or a value stream to identify the possible need for process optimisation.

Lean management is a philosophy based on 6 basic strategies:

• continuous material flow
• simultaneous engineering
• strategic use of capital
• Company as a family
• proactive marketing
• comprehensive quality management

• low inventories
• Reduction of inventory and factory space
• Optimisation in the use of human resources
•  Reduction of rejects and defects
• Time reduction in product development, with an increase in product variety

‘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]

A legal compliance audit is a review of whether all laws, regulations and notices affecting the company are being complied with.

‘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]

Shortcut for Lean Initial Audit

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]

Last In - First Out;  denotes a possible structure within a queue of goods or documents.

‘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.

[Definition according to (EU) 2017/746 Article 2 No. 54].

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]

Food Hygiene Regulation; in German: Lebensmittelhygiene-Verordnung.

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]

Lowest In - First Out; the item with the highest value is taken out first - refers to a possible structure within a queue of goods or documents.

Normally intended for continuous use for more than 30 days.

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

Normally intended for continuous use for more than 30 days.

[Definition according to (93/42/EEC) Annex IX No. 1.1]

‘Long term’ means normally intended for continuous use for more than 30 days.

[Definition according to (EU) 2017/745 Annex VIII Chapter I No. 1.3]

Named after its discoverer, the US statistician and economist Max Otto Lorenz. It graphically represents the inequality of statistical distribution.