Our glossary for guidance - Letter N

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]

‘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.

[Definition according to (EU) 2017/745 Article 2 No. 18]

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]

Net Equipment Effectiveness (NEE) = Net Total Equipment Effectiveness (NGE).
Formula: NEE = Performance*Quality
Compare with OEE and TEEP.

‘Negative predictive value’ means 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 (EU) 2017/746 Article 2 No. 53].

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]

Net means a value minus all "added" values (e.g. tare, taxes, etc.).

Ex: Gross weight - tare weight = net weight.

With the help of a network diagram, logical connections can be shown and thus enable the determination of critical points/processes.

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]
 

Food and Catering Union.

‘Non-viable’ means having no potential for metabolism or multiplication.

[Definition according to (EU) 2017/745 Article 2 No. 16]

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]

’Notified body’ means a conformity assessment body designated in accordance with this Regulation.

[Definition under (EU) 2017/745 Article 2 No. 42 also corresponds to definition under (EU) 2017/746 Article 2 No. 34]