Regulation (EU) 2016/425 of the European Parliament and of the CouncilShow full title

Article 3 U.K. Definitions

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.