S.L. 454.2 чл. 2Scope. S.L. 419.07.

(1) These regulations:

(a) implement Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (recast);

(b) cover non-automatic weighing instruments which are new to the Union market when they are placed on the market; that is to say they are either new non-automatic weighing instruments made by a manufacturer established in the Union or non-automatic weighing instruments, whether new or second-hand, imported from a third country; and

(c) apply to all non-automatic weighing instruments.

(2) For the purposes of these regulations, the following categories of use of non-automatic weighing instruments shall be distinguished:

(a) the determination of mass for commercial transactions;

(b) the determination of mass for the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment;

(c) the determination of mass for the application of laws or regulations or for an expert opinion given in court proceedings;

(d) the determination of mass in the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment;

(e) the determination of mass for making up medicines on prescription in a pharmacy and determination of mass in analyses carried out in medical and pharmaceutical laboratories;

(f) the determination of price on the basis of mass for the purposes of direct sales to the public and the making-up of pre-packages;

(g) all applications other than those listed in paragraphs

*See regulation 1(2) of these regulations as originally promulgated. 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;

"Authority" means the Standards and Metrology Institute of the Malta Competition and Consumer Affairs Authority;

"CE marking" means a marking by which the manufacturer indicates that the instrument is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing; "competent national authorities" means the Standards and Metrology Institute within the Malta Competition and Consumer Affairs Authority authorised to enforce these regulations, and where the context requires, competent national authorities of other Member States; "conformity assessment" means the process demonstrating whether the essential requirements of these regulations relating to an instrument have been fulfilled;

"conformity assessment body" means a body that performs conformity assessment activities including calibration, testing, certification and inspection; "distributor" means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes an instrument available on the market; "economic operators" means the manufacturer, the authorised representative, the importer and the distributor; "harmonised standard" means harmonised standard as defined in paragraph (c) of paragraph 1 of Article 2 of Regulation (EU) No 1025/2012;

"importer" means any natural or legal person established within the Union who places an instrument from a third country on the Union market; "making available on the market" means any supply of an instrument 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 an instrument or has an instrument designed or manufactured, and markets that instrument under his name or trade mark; "market surveillance authorities" means the Standards and Metrology Institute within the Malta Competition and Consumer Affairs Authority acting in the capacity of market surveillance Accreditation Board (Malta) established in terms of regulation 3 of the National Accreditation Board (Malta) (Establishment) Regulations;

"non-automatic weighing instrument" or "instrument" means a weighing instrument requiring the intervention of an operator during weighing; "notifying authority" means the notifying authority established in regulation 21(1); "placing on the market" means the first making available of an instrument on the Union market; "recall" means any measure aimed at achieving the return of an instrument that has already been made available to the end-user; "technical specification" means a document that prescribes technical requirements to be fulfilled by an instrument; "Union harmonisation legislation" means any Union legislation harmonising the conditions for the marketing of products; "weighing instrument" means a measuring instrument serving to determine the mass of a body by using the action of gravity on that body. A weighing instrument may also serve to determine other mass-related magnitudes, quantities, parameters or characteristics;

"withdrawal" means any measure aimed at preventing an instrument in the supply chain from being made available on the market.