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The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972 [1] in relation to measures relating to the design and construction of, and to the placing on the market and putting into service of, machinery [2] and safety components for machinery [3], in exercise of the powers conferred on her by that section, hereby makes the following Regulations: Citation and commencement 1. These Regulations may be cited as the Supply of Machinery (Safety) (Amendment) Regulations 2005 and shall come into force on 1st May 2005. Amendment of, and supplementary provisions relating to, the Supply of Machinery (Safety) Regulations 1992 2. - (1) The Supply of Machinery (Safety) Regulations 1992 [4] ("the principal Regulations") are hereby amended as follows -
(c) in regulation 2(2), in the definition of "harmonised standard" for the words from "Council Directive 83/189/EEC" to "technical standards and regulations", there shall be substituted "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 [7]";
(b) appointed by an EEA State other than the United Kingdom; or (c) recognised for the purpose of carrying out those functions by inclusion in a mutual recognition agreement, relating to the Machinery Directive, or a similar agreement (including a Protocol to the European Agreement, or other Agreement, on Conformity Assessment and Acceptance of Industrial Products) which has been concluded between the European Community and a State other than an EEA State;
and in the case of either (a) or (b) above has been notified by the EEA State concerned to the Commission and the other EEA State pursuant to Article 9(1) of the Machinery Directive.";
(f) for regulation 30(1), there shall be substituted -
(b) on conviction on indictment,to a fine or to imprisonment for a term not exceeding two years or to both. ";
(g) in Schedule 5, for the words "Machinery for medical use, used in direct contact with patients" there shall be substituted "Medical devices: for the purposes of this Schedule "Medical devices" shall have the meaning ascribed to those words by the Medical Devices Regulations 2002 [8]"; [9] and
(2) Notwithstanding the amendment made by paragraph (1)(a) above,
(b) for the purposes of regulation 23(3)(f), a declaration of incorporation,
Consequential Amendments
(b) section 1.1 (the head note and both places) and section 5 of Annex 1 to the Lifts Directive as set out in Schedule 1.
4.
In the second column of Schedule 1 to the Provision and Use of Work Equipment Regulations 1998 [12] -
(b) relating to the entry for the Lifts Regulations 1997 in the first column, to the reference to "S.I. 1997/831" there shall be added ", amended by S.I. 2005/831".
5.
In the Lifting Operations and Lifting Equipment Regulations 1998 [13], in regulation 2(1) for the definition of "the 1992 Regulations" there shall be substituted ""the 1992 Regulations" means the Supply of Machinery (Safety) Regulations 1992 [14] as amended by regulation 2(1)(a) of the Supply of Machinery (Safety) (Amendment) Regulations 2005 [15];". (This note is not part of the Regulations) These Regulations amend the Supply of Machinery (Safety) Regulations 1992 as amended (the "principal Regulations"). They amend certain definitions in regulation 2 of the principal Regulations as follows:
(b) the definition of "enforcement authority" to reflect changes made in Northern Ireland (regulation 2(1)(b)); and (c) the definition of "harmonised standard" to reflect the consolidation of Council Directive 83/189/EEC (as amended) in Directive 98/34/EC (OJ No. L204, 21.7.98, p.37) (regulation 2(1)(c)).
Regulation 2(1)(d) substitutes wording for regulation 17 of the principal Regulations, to reflect the recognition of notified bodies under various agreements. Notes: [1] 1972 c.68.back [4] S.I. 1992/3073 as amended by S.I. 1994/2063.back [5] OJ No. L207, 23.7.98, p.1.back [6] See Article 12 of the Health and Safety at Work (Northern Ireland) Order (S.I. 1978/1039 (N.I.9); Article 12 was amended by S.I. 1998/2795 (N.I. 18), Article 6(1) and paragraph 8 of Schedule 1.back [7] OJ No. L204, 21.7.98, p.37; Directive 98/34/EC has been amended by Directive 98/48/EC of the European Parliament and of the Council (OJ No. L217, 5.8.98, p.18).back [8] S.I. 2002/618 to which there is an amendment not relevant to these Regulations.back [9] This sub-paragraph implements Article 21(1) of Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices (OJ No. L331, 7.12.98, p.1) the remainder of which has been implemented in S.I. 2002/618.back [11] Directive 98/37/EC (OJ No. L207, 23.7.98, p.1).back [12] S.I. 1998/2306 as amended by S.I. 2002/2174.back [13] S.I. 1998/2307; there are amendments not relevant to these Regulations.back [14] S.I. 1992/3073; there are amendments not relevant to these Regulations.back
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