S.L. 427.57 Art. 3Definitions.

In these regulations, unless the context otherwise requires:

"authorised representative" means any natural or legal person established within the European Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;

"availability of a substitute" means the ability of a substitute to be manufactured and delivered within a reasonable period of time as compared with the time required for manufacturing and delivering the substances listed in Schedule II; "active implantable medical device" means any active implantable medical device within the meaning of regulation 3 of the Active Implantable Medical Devices Regulations;

"cables" means all cables with a rated voltage of less than 250 volts that serve as a connection or an extension to connect electrical and electronic equipment to the electrical outlet or to connect two or more electrical and electronic equipment to each other; "CE marking" means a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in European Union harmonisation legislation providing for its affixing; "competent authority" means Malta Competition and Consumer Affairs Authority established by the Malta Competition and Consumer Affairs Authority Act;

"conformity assessment" means the process demonstrating whether the requirements of these regulations relating to an electrical and electronic equipment, are met; "dependent", within the context of the definition "electrical and electronic equipment" means the need of electric currents or electromagnetic fields to fulfil at least one intended function; "distributor" means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes electrical and electronic equipment available on the market;

"economic operators" means the manufacturer, the authorised representative, the importer and the distributor;

"electrical and electronic equipment" means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields and designed for use with a voltage rating not exceeding 1000 volts for alternating current and 1500 volts for direct current; "harmonised standard" means a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/ 34/ EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services on the basis of a request made by the Commission in accordance with Article 6 of Directive 98/34/EC;

"homogeneous material" means one material of uniform composition throughout or a material, consisting of a combination of materials, that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes;

"importer" means any natural or legal person established within the European Union, who places an electrical and electronic equipment from a third country on the European Union market; "in diagnostic medical device’ means an diagnostic vitro in vitro medical device within the meaning of regulation 3 of the In Vitro Diagnostic Medical Devices Regulations; "industrial monitoring and control instruments" means monitoring and control instruments designed for exclusively industrial or professional use;

"large-scale fixed installation" means a large-scale combination of several types of apparatus and, where applicable, other devices, which are assembled and installed by professionals, intended to be used permanently in a pre-defined and dedicated location, and de-installed by professionals;

"large-scale stationary industrial tools" means a large-scale assembly of machines, equipment, and, or components, functioning together for a specific application, permanently installed and de-installed by professionals at a given place, and used and maintained by professionals in an industrial manufacturing facility or research and development facility; "making available on the market" means any supply of electrical and electronic equipment for distribution, consumption or use on the European 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 electrical and electronic equipment or who has electrical and electronic equipment designed or manufactured and markets it under his name or trademark;

"market surveillance" means the activities carried out and measures taken by the Division to ensure that electrical and electronic equipment complies with the requirements set out in these regulations and does not endanger health, safety or other issues of public interest protection;

"medical device" means a medical device within the meaning of regulation 3 of the Medical Devices Regulations and includes electrical and electronic equipment; "non-road mobile machinery made available exclusively for professional use" means machinery, with an on-board power source or with a traction drive powered by an external power source, the operation of which requires either mobility or continuous or semi-continuous movement between a succession of fixed working locations while working, and which is made available exclusively for professional use;

"placing on the market" means making available an electrical and electronic equipment on the European Union market for the first time; "recall" means any measure aimed at achieving the return of a product that has already been made available to the end user; "reliability of a substitute" means the probability that an electrical and electronic equipment using a substitute will perform a required function without failure under stated conditions for a stated period of time;

"spare part" means a separate part of an electrical and electronic equipment that can replace a part of an electrical and electronic equipment. The electrical and electronic equipment cannot function as intended without that part of the electrical and electronic equipment. The functionality of electrical and electronic equipment is restored or is upgraded when the part is replaced by a spare part; "Technical Regulations Division" means the Technical Regulations Division established by article 19 of the Malta Competition and Consumer Affairs Authority Act, hereinafter referred to as "competent authority"; "technical specification" means a document that prescribes technical requirements to be fulfilled by a product, process or service; "waste electrical and electronic equipment" or "WEEE" means electrical and electronic equipment which is waste as defined in regulation 4 of the Waste Regulations, including all components, sub-assemblies and consumables which are part of the product at the time of discarding; "withdrawal" means any measure aimed at preventing a product in the supply chain from being made available on the market.