For the purposes of this Directive, the following definitions apply:
(1)
‘product’ means all movables, even if integrated into, or inter-connected with, another movable or an immovable; it includes electricity, digital manufacturing files, raw materials and software;
(2)
‘digital manufacturing file’ means a digital version of, or digital template for, a movable which contains the functional information necessary to produce a tangible item by enabling the automated control of machinery or tools;
(3)
‘related service’ means a digital service that is integrated into, or inter-connected with, a product in such a way that its absence would prevent the product from performing one or more of its functions;
(4)
‘component’ means any item, whether tangible or intangible, raw material or related service, that is integrated into, or inter-connected with, a product;
(5)
‘manufacturer’s control’ means that:
(a)
the manufacturer of a product performs or, with regard to actions of a third party, authorises or consents to:
(i)
the integration, inter-connection or supply of a component, including software updates or upgrades; or
(ii)
the modification of the product, including substantial modifications;
(b)
the manufacturer of a product has the ability to supply software updates or upgrades, themselves or via a third party;
(6)
‘data’ means data as defined in Article 2, point (1), of Regulation (EU) 2022/868 of the European Parliament and of the Council (18);
(7)
‘making available on the market’ means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
(8)
‘placing on the market’ means the first making available of a product on the Union market;
(9)
‘putting into service’ means the first use of a product in the Union in the course of a commercial activity, whether in return for payment or free of charge, in circumstances in which that product has not been placed on the market prior to its first use;
(10)
‘manufacturer’ means any natural or legal person who:
(a)
develops, manufactures or produces a product;
(b)
has a product designed or manufactured, or who, by putting their name, trademark or other distinguishing features on that product, presents themselves as its manufacturer; or
(c)
develops, manufactures or produces a product for their own use;
(11)
‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on that manufacturer’s behalf in relation to specified tasks;
(12)
‘importer’ means any natural or legal person who places a product from a third country on the Union market;
(13)
‘fulfilment service provider’ means any natural or legal person offering, in the course of a commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching of a product, without having ownership of that product, excluding postal services as defined in Article 2, point (1), of Directive 97/67/EC of the European Parliament and of the Council (19), parcel delivery services as defined in Article 2, point (2), of Regulation (EU) 2018/644 of the European Parliament and of the Council (20), and any other postal services or freight transport services;
(14)
‘distributor’ means any natural or legal person in the supply chain who makes a product available on the market, other than the manufacturer or importer of that product;
(15)
‘economic operator’ means a manufacturer of a product or component, a provider of a related service, an authorised representative, an importer, a fulfilment service provider or a distributor;
(16)
‘online platform’ means online platform as defined in Article 3, point (i), of Regulation (EU) 2022/2065;
(17)
‘trade secret’ means trade secret as defined in Article 2, point (1), of Directive (EU) 2016/943;
(18)
‘substantial modification’ means a modification of a product after it has been placed on the market or put into service:
(a)
that is considered substantial under relevant Union or national rules on product safety; or
(b)
where relevant Union or national rules on product safety lay down no threshold on what is to be considered a substantial modification, that:
(i)
changes the product’s original performance, purpose or type, without that change having been foreseen in the manufacturer’s initial risk assessment; and
(ii)
changes the nature of the hazard, creates a new hazard or increases the level of risk.