For the purposes of this Regulation, the following definitions apply:
(1)((1)) ‘personal protective equipment’ (PPE) means:
(a)((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)((b)) interchangeable components for equipment referred to in point (a) which are essential for its protective function;
(c)((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)((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)((3)) ‘placing on the market’ means the first making available of PPE on the Union market;
(4)((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)((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)((6)) ‘importer’ means any natural or legal person established within the Union who places PPE from a third country on the Union market;
(7)((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)((8)) ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;
(9)((9)) ‘technical specification’ means a document that prescribes technical requirements to be fulfilled by PPE;
(10)((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)((11)) ‘accreditation’ means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;
(12)((12)) ‘national accreditation body’ means a national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;
(13)((13)) ‘conformity assessment’ means the process demonstrating whether the essential health and safety requirements of this Regulation relating to PPE have been fulfilled;
(14)((14)) ‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification and inspection;
(15)((15)) ‘recall’ means any measure aimed at achieving the return of PPE that has already been made available to the end-user;
(16)((16)) ‘withdrawal’ means any measure aimed at preventing PPE in the supply chain from being made available on the market;
(17)((17)) ‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products;
(18)((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.affixing;
(19)‘crisis-relevant goods’ means crisis-relevant goods as defined in Article 3, point (6), of Regulation (EU) 2024/2747 of the European Parliament and of the Council (1);
(20)‘internal market emergency mode’ means internal market emergency mode as defined in Article 3, point (3), of Regulation (EU) 2024/2747.