This Directive establishes the requirements that measuring instruments have to satisfy with a view to their being made available on the market and/or put into use for the measuring tasks referred to in Article 3(1).

For the purposes of this Directive, the following definitions shall apply:

1. (1)

   ‘measuring instrument’ means any device or system with a measurement function that is covered by Article 2(1);

2. (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. (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. (4)

   ‘normative document’ means a document containing technical specifications adopted by the International Organisation of Legal Metrology;

5. (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. (6)

   ‘placing on the market’ means the first making available of a measuring instrument on the Union market;

7. (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. (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. (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. (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. (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. (12)

    ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;

13. (13)

    ‘technical specification’ means a document that prescribes technical requirements to be fulfilled by a measuring instrument;

14. (14)

    ‘harmonised standard’ means harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;

15. (15)

    ‘accreditation’ means accreditation as defined in point 10 of Article 2 of Regulation (EC) no 765/2008;

16. (16)

    ‘national accreditation body’ means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) no 765/2008;

17. (17)

    ‘conformity assessment’ means the process demonstrating whether the essential requirements of this Directive relating to a measuring instrument have been fulfilled;

18. (18)

    ‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

19. (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. (20)

    ‘withdrawal’ means any measure aimed at preventing a measuring instrument in the supply chain from being made available on the market;

21. (21)

    ‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products;

22. (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.

Where instrument-specific annexes lay down the essential requirements for sub-assemblies, this Directive shall apply mutatis mutandis to such sub-assemblies.

Sub-assemblies and measuring instruments may be assessed independently and separately for the purpose of establishing conformity.

A measuring instrument shall meet the essential requirements set out in Annex I and in the relevant instrument-specific Annex.

Member States may require, if it is needed for correct use of the instrument, the information referred to in point 9 of Annex I or in the relevant instrument-specific Annexes to be provided in a language which can be easily understood by end-users, as determined by the Member State in which the instrument is made available on the market.