Article 4

For the purposes of this Directive, the following definitions apply:

‘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;

‘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;

‘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;

‘component’ means any item, whether tangible or intangible, raw material or related service, that is integrated into, or inter-connected with, a product;

‘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;

‘data’ means data as defined in Article 2, point (1), of Regulation (EU) 2022/868 of the European Parliament and of the Council;

‘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;

‘placing on the market’ means the first making available of a product on the Union market;

‘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;

‘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;

‘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;

‘importer’ means any natural or legal person who places a product from a third country on the Union market;

‘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, parcel delivery services as defined in Article 2, point (2), of Regulation (EU) 2018/644 of the European Parliament and of the Council, and any other postal services or freight transport services;

‘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;

‘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;

‘online platform’ means online platform as defined in Article 3, point (i), of Regulation (EU) 2022/2065;

‘trade secret’ means trade secret as defined in Article 2, point (1), of Directive (EU) 2016/943;

‘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.