Regulation (EU) 2016/425 Article 3: Definitions

Article 3 - Definitions

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Article 3

Definitions

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

((1))

‘personal protective equipment’ (PPE) means:

((a))

equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety;

((b))

interchangeable components for equipment referred to in point (a) which are essential for its protective function;

((c))

connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use;

((2))

‘making available on the market’ means any supply of PPE for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

((3))

‘placing on the market’ means the first making available of PPE on the Union market;

((4))

‘manufacturer’ means any natural or legal person who manufactures PPE or has it designed or manufactured, and markets it under his name or trademark;

((5))

‘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;

((6))

‘importer’ means any natural or legal person established within the Union who places PPE from a third country on the Union market;

((7))

‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes PPE available on the market;

((8))

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

((9))

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

((10))

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

((11))

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

((12))

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

((13))

‘conformity assessment’ means the process demonstrating whether the essential health and safety requirements of this Regulation relating to PPE have been fulfilled;

((14))

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

((15))

‘recall’ means any measure aimed at achieving the return of PPE that has already been made available to the end-user;

((16))

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

((17))

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

((18))

‘CE marking’ means a marking by which the manufacturer indicates that PPE is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing.