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Article 2 – Definitions

NLF 765 Accreditation and market surveillance (765/2008) (EC) No 765/2008 · Consolidated version of 16 Jul 2021 · Official text on EUR-Lex

CHAPTER I – GENERAL PROVISIONS

For the purposes of this Regulation the following definitions shall apply:

3. ‘manufacturer’ shall mean any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark;

4. ‘authorised representative’ shall mean any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks with regard to the latter's obligations under the relevant Community legislation;

5. ‘importer’ shall mean any natural or legal person established within the Community who places a product from a third country on the Community market;

6. ‘distributor’ shall mean any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;

7. ‘economic operators’ shall mean the manufacturer, the authorised representative, the importer and the distributor;

8. ‘technical specification’ shall mean a document that prescribes technical requirements to be fulfilled by a product, process or service;

9. ‘harmonised standard’ shall mean a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (

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) on the basis of a request made by the Commission in accordance with Article 6 of that Directive;

10. ‘accreditation’ shall mean an attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity;

11. ‘national accreditation body’ shall mean the sole body in a Member State that performs accreditation with authority derived from the State;

12. ‘conformity assessment’ shall mean the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled;

13. ‘conformity assessment body’ shall mean a body that performs conformity assessment activities including calibration, testing, certification and inspection;

16. ‘peer evaluation’ shall mean a process for the assessment of a national accreditation body by other national accreditation bodies, carried out in accordance with the requirements of this Regulation, and, where applicable, additional sectoral technical specifications;

20. ‘CE marking’ shall mean a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Community harmonisation legislation providing for its affixing;

21. ‘Community harmonisation legislation’ shall mean any Community legislation harmonising the conditions for the marketing of products.

“Definitions” in other acts

Contents of the act: Accreditation and market surveillance (765/2008)