S.L. 427.35 Art. 2Interpretation.

(1) In these regulations, unless the context otherwise requires:

"accreditation" means an attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity; "apparatus" means any finished appliance or combination thereof made commercially available as a single functional unit, intended for the end user and liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance; "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; "CE marking" means a marking by which the manufacturer indicates that the apparatus is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing.

"common specifications" means a set of technical requirements established to ensure compliance with regulatory obligations when harmonised standards are unavailable or insufficient;

* See regulation 1(5) of these Regulations as originally promulgated. "conformity assessment" means the process demonstrating whether the essential requirements of these regulations relating to an apparatus have been fulfilled; "conformity assessment body" means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

"crisis-relevant goods" means goods that are non-substitutable, non-diversifiable or indispensable in the maintenance of vital societal functions or economic activities in order to ensure the proper functioning of the internal market and its supply chains and that are considered essential for responding to a crisis during the internal market emergency mode that may be activated in accordance with Article 18(4) of Regulation (EU) 2024/2747 with respect to equipment covered by these regulations; "Director General" means the Director General (Technical Regulations) as defined in article 2 of the Malta Competition and Consumer Affairs Act; "distributor" means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes apparatus available on the market;

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

"electromagnetic compatibility" means the ability of equipment to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbances to other equipment in that environment; "electromagnetic disturbance" means any electromagnetic phenomenon which may degrade the performance of equipment. An electromagnetic disturbance may be electromagnetic noise, an unwanted signal or a change in the propagation medium itself; "electromagnetic environment" means all electromagnetic phenomena observable in a given location; "equipment" means any apparatus or fixed installation;

"European standard’ means a standard adopted by a European standardisation organisation;

"fixed installation" means a particular combination of several types of apparatus and, where applicable, other devices, which are assembled, installed and intended to be used permanently at a predefined location; "harmonised standard" means a European standard adopted on the basis of a request made by the Commission for the application of Union harmonization legislation;

"immunity" means the ability of equipment to perform as intended without degradation in the presence of an electromagnetic disturbance; "implementing act" means a non-legislative act adopted by the European Commission for the purpose of providing rules and measures necessary for the implementation of these regulations and which are essential to provide for crisis situations during an internal market emergency mode activated in accordance with Article 18(4) of Regulation (EU) 2024/2747 with respect to equipment covered by these regulations;

"importer" means any natural or legal person established within the Union who places apparatus from a third country on the Union market; "internal market emergency mode" means internal market emergency mode as defined in point (3) of Article 3 of Regulation

(EU) 2024/2747; "making available on the market" means any supply of apparatus 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; "manufacturer" means any natural or legal person who manufactures apparatus or has apparatus designed or manufactured, and markets that apparatus under his name or trade mark; "MCCAA" means the Malta Competition and Consumer Affairs Authority, as established by the Malta Competition and Consumer Affairs Act;

"Member State" means a member state of the European Union; "mobile installations" are defined as a combination of apparatus and, where applicable, other devices, intended to be moved and operated in a range of locations;

"MSD" means the Market Surveillance Directorate within the TRD;

"national accreditation body" means the sole body in a Member State that performs accreditation with authority derived from the State; "notified body" means a conformity assessment body which has been officially designated by its national authority and notified to the European Commission to carry out the procedures for conformity assessment of certain products in terms of regulation 14 before being placed on the market; "placing on the market" means the first making available of apparatus on the Union market; "recall" means any measure aimed at achieving the return of apparatus that has already been made available to the end-user; "Regulation (EU) 2024/2747" means Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) "safety purposes" means the purposes of safeguarding human life or property. "technical specification" means a document that prescribes technical requirements to be fulfilled by the equipment; "TRD" means the Technical Regulations Division of the MCCAA, established by the Malta Competition and Consumer Affairs Act; "Union harmonization legislation" means any Union legislation harmonising the conditions for the marketing of products; "withdrawal" means any measure aimed at preventing apparatus in the supply chain from being made available on the market.

(2) For the purposes of these regulations, the following shall be considered as apparatus:

(a) "components" or "sub-assemblies" intended for incorporation into an apparatus by the end-user, which are liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance; and

(b) "mobile installations" defined as a combination of apparatus and, where applicable, other devices, intended to be moved and operated in a range of locations.