Defined terms — Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)
European Union · 32016R0425 · 1269 provisions
18 defined in this instrument.
accreditation — accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008 (11)
authorised representative — 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 (5)
CE marking — 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 (18)
conformity assessment — the process demonstrating whether the essential health and safety requirements of this Regulation relating to PPE have been fulfilled (13)
conformity assessment body — a body that performs conformity assessment activities including calibration, testing, certification and inspection (14)
distributor — any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes PPE available on the market (7)
economic operators — the manufacturer, the authorised representative, the importer and the distributor (8)
harmonised standard — a harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012 (10)
importer — any natural or legal person established within the Union who places PPE from a third country on the Union market (6)
making available on the market — 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 (2)
manufacturer — any natural or legal person who manufactures PPE or has it designed or manufactured, and markets it under his name or trademark (4)
national accreditation body — a national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008 (12)
personal protective equipment — 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;
interchangeable components for equipment referred to in point (a) which are essential for its protective function;
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 (1)
placing on the market — the first making available of PPE on the Union market (3)
recall — any measure aimed at achieving the return of PPE that has already been made available to the end-user (15)
technical specification — a document that prescribes technical requirements to be fulfilled by PPE (9)
Union harmonisation legislation — any Union legislation harmonising the conditions for the marketing of products (17)
withdrawal — any measure aimed at preventing PPE in the supply chain from being made available on the market (16)