CHAPTER 1

GENERAL PROVISIONS

Definitions
Article 4
For the purposes of this Directive, the following definitions shall apply:
1. ‘measuring instrument’ means any device or system with a measurement function that is covered by Article 2(1);
2. ‘sub-assembly’ means a hardware device, mentioned as such in the instrument-specific annexes, that functions independently and makes up a measuring instrument together with other sub-assemblies with which it is compatible, or with a measuring instrument with which it is compatible;
3. ‘legal metrological control’ means the control of the measurement tasks intended for the field of application of a measuring instrument, for reasons of public interest, public health, public safety, public order, protection of the environment, levying of taxes and duties, protection of the consumers and fair trading;
4. ‘normative document’ means a document containing technical specifications adopted by the International Organisation of Legal Metrology;
5. ‘making available on the market’ means any supply of a measuring instrument for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
6. ‘placing on the market’ means the first making available of a measuring instrument on the Union market;
7. ‘putting into use’ means the first use of a measuring instrument intended for the end-user for the purposes for which it was intended;
8. ‘manufacturer’ means any natural or legal person who manufactures a measuring instrument or has a measuring instrument designed or manufactured, and markets that measuring instrument under his name or trade mark or puts it into use for his own purposes;
9. ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;
10. ‘importer’ means any natural or legal person established within the Union who places a measuring instrument from a third country on the Union market;
11. ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a measuring instrument available on the market;
12. ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;
13. ‘technical specification’ means a document that prescribes technical requirements to be fulfilled by a measuring instrument;
14. ‘harmonised standard’ means harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;
15. ‘accreditation’ means accreditation as defined in point 10 of Article 2 of Regulation (EC) no 765/2008;
16. ‘national accreditation body’ means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) no 765/2008;
17. ‘conformity assessment’ means the process demonstrating whether the essential requirements of this Directive relating to a measuring instrument have been fulfilled;
18. ‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification and inspection;
19. ‘recall’ means any measure aimed at achieving the return of a measuring instrument that has already been made available to the end-user;
20. ‘withdrawal’ means any measure aimed at preventing a measuring instrument in the supply chain from being made available on the market;
21. ‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products;
22. ‘CE marking’ means a marking by which the manufacturer indicates that the measuring instrument is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing.