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;
(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 (
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(20) ‘internal market emergency mode’ means internal market emergency mode as defined in Article 3, point (3), of Regulation (EU) 2024/2747.