# 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), Article 3: Definitions

Extent: E+W+S+N.I.

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 market of Great Britain 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 market of Great Britain;
(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 United Kingdom who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;
(6)importer” means a person who—
(a)is established in the United Kingdom and places PPE from a country outside of the United Kingdom on the market; or
(b)is established in Northern Ireland and places PPE on the market that has been supplied to them for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge, from an EEA state;
(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). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(11). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(12). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(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). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(18). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(19)‘approved body’ has the meaning given in Article 20;
(20)‘designated standard’ has the meaning given in Article 7A;
(21)‘enforcement authority’ means a person enforcing this Regulation under regulation 4 of the Personal Protective Equipment (Enforcement) Regulations 2018 (S.I. 2018/390);
(22)‘UK Marking’ means the marking in the form set out in Annex 2 of Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products, and repealing Regulation (EEC) 339/93;
(23)‘UK national accreditation body’ means the body appointed by the Secretary of State in accordance with Article 4 of Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products, and repealing Regulation (EEC) 339/93;
(24)‘Regulation 2016/425 (pre-exit)’ means Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC, as it had effect immediately before IP completion day;
(25)In this Regulation, references to “the market surveillance authority” are to be construed in accordance with regulation 3 of the Personal Protective Equipment (Enforcement) Regulations 2018.

---
Source: https://www.legislation.gov.uk/eur/2016/425/article/3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2016-425/article-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.