- accreditation
means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;
- 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;
- conformity assessment
means the process demonstrating whether the essential health and safety requirements of this Regulation relating to PPE have been fulfilled;
- conformity assessment body
means a body that performs conformity assessment activities including calibration, testing, certification and inspection;
- 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;
- 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;
- economic operators
means the manufacturer, the authorised representative, the importer and the distributor;
- harmonised standard
means a harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;
- importer
means any natural or legal person established within the Union who places PPE from a third country on the Union market;
- internal market emergency mode
means internal market emergency mode as defined in Article 3, point (3), of Regulation (EU) 2024/2747.
- 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;
- manufacturer
means any natural or legal person who manufactures PPE or has it designed or manufactured, and markets it under his name or trademark;
- national accreditation body
means a national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;
- personal protective equipment
(PPE) means:
- placing on the market
means the first making available of PPE on the Union market;
- recall
means any measure aimed at achieving the return of PPE that has already been made available to the end-user;
- technical specification
means a document that prescribes technical requirements to be fulfilled by PPE;
- Union harmonisation legislation
means any Union legislation harmonising the conditions for the marketing of products;
- withdrawal
means any measure aimed at preventing PPE in the supply chain from being made available on the market;