The Electromagnetic Compatibility Regulations 2016

• Citation: S.I. 2016/1091
• Sections: 185

Section 1 Citation and commencement

These Regulations may be cited as the Electromagnetic Compatibility Regulations 2016 and come into force on 8th December 2016.

Section 2 Interpretation

(1) In these Regulations—

the “ 1987 Act ” means the Consumer Protection Act 1987 ;

the “ 2006 Regulations ” means the Electromagnetic Compatibility Regulations 2006 ;

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“ approved body ” has the meaning given in regulation 43 (approved bodies);

“ apparatus ” means any finished appliance or combination thereof made available on the market 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 and includes—

components or sub-assemblies intended for incorporation into an apparatus by an end-user, which are liable to generate or be affected by electromagnetic disturbance;

a mobile installation defined as a combination of apparatus and, where applicable, other devices, intended to be moved and operated in a range of locations;

“ authorised representative ” means a person established within the United Kingdom appointed in accordance with regulation 38 (appointment of an authorised representative);

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“ conformity assessment ” means the process demonstrating whether the essential requirements relating to apparatus have been fulfilled;

“ conformity assessment body ” means a body that performs conformity assessment activities;

“ conformity assessment procedure ” means a procedure referred to in regulation 40;

“ declaration of conformity ” means a declaration of conformity required to be drawn up in accordance with regulation 10(1)(a) (declaration of conformity and UK marking);

“ designated standard ” has the meaning given to it in regulation 2A;

“ the Directive ” means Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of laws of the Member States relating to electromagnetic compatibility (recast) ...;

“ distributor ” means any person in the supply chain, other than the manufacturer, authorised representative or importer, who makes apparatus available on the market;

“ district council ” means a district council within the meaning of the Local Government Act (Northern Ireland) 1972 ;

“ economic operator ” means a manufacturer, authorised representative, importer or 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;

“enforcing authority” is to be interpreted in accordance with regulation 52 (designation of enforcing authorities);

“ equipment ” means any apparatus or fixed installation;

“ essential requirements ” means the requirements set out in Schedule 1;

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“ European Commission ” means the Commission of the European Union;

“ 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;

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“ immunity ” means the ability of equipment to perform as intended without degradation in the presence of electromagnetic disturbance;

“ importer ” means a person who—

is established in the United Kingdom and places apparatus from a country outside of the United Kingdom on the market; or

is established in Northern Ireland and places apparatus on the market that has been supplied to them for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge, from an EEA state;

“ make available on the market ” means any supply of apparatus for distribution or use on the market of Great Britain in the course of a commercial activity, whether in return for payment or free of charge, and related expressions must be construed accordingly;

“ manufacturer ” means a person who—

manufactures apparatus or has apparatus designed or manufactured; and

markets that apparatus under that person's name or trademark;

“ market surveillance authority ” has the meaning given in regulation 53 (designation of market surveillance authorities);

“ mobile installation ” means a combination of apparatus and, where applicable, other devices, which are intended to be moved and operated in a range of locations;

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“ OFCOM ” means the Office of Communications established under the Office of Communications Act 2002 ;

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“ place on the market ” means the first making available of apparatus on the market of Great Britain , and related expressions must be construed accordingly;

“ put into service ” means the first use of equipment in the United Kingdom market by its end-user for the purposes for which it was intended, and related expressions must be construed accordingly;

“ RAMS ” means Regulation ( EC ) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation ( EEC ) No 339/93 ;

“ recall ” means any measure aimed at achieving the return of apparatus that has already been made available to the end-user, and related expressions must be construed accordingly;

“ relevant conformity assessment procedure ” means a conformity assessment procedure referred to in regulation 40 (conformity assessment procedures);

“ relevant economic operator ” means, in relation to apparatus, an economic operator with obligations in respect of that apparatus under Part 2;

“ technical specification ” means a document that prescribes technical requirements to be fulfilled by the equipment;

“ UK marking ” means the marking in the form set out in Annex 2 of RAMS;

“ UK national accreditation body ” means the body appointed by the Secretary of State in accordance with Article 4 of RAMS;

“ weights and measures authority ” means a local weights and measures authority within the meaning set out in section 69 of the Weights and Measures Act 1985 ;

“ withdrawal ” means any measure aimed at preventing apparatus in the supply chain from being made available on the market, and related expressions must be construed accordingly.

(2) In these Regulations, a reference to apparatus or equipment being “ in conformity with Part 2 ” means that—

(a) the apparatus or equipment is in conformity with the essential requirements; and

(b) each relevant economic operator has complied with the obligations imposed on them under Part 2 which must be satisfied at or before the time at which they make the apparatus or equipment available on the market.

(3) In these Regulations, “ risk ” means a risk to the protections against electromagnetic disturbance referred to in these Regulations .

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Section 2A Designated standard

(1) Subject to paragraphs (6) and (7), in these Regulations a “ designated standard ” means a technical specification which is—

(a) adopted by a recognised standardisation body or an international standardising body , for repeated or continuous application, with which compliance is not compulsory; and

(b) designated by the Secretary of State by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate.

(2) For the purposes of paragraph (1), a “ technical specification ” means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following—

(a) the characteristics required of a product, including—

(i) levels of quality, performance, interoperability, environmental protection, health, safety or dimensions, and

(ii) the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; and

(b) production methods and processes relating to the product, where these have an effect on the characteristics of the product.

(3) For the purposes of this regulation a “ recognised standardisation body ” means any one of the following organisations—

(a) the European Committee for Standardisation (CEN);

(b) the European Committee for Electrotechnical Standardisation (Cenelec);

(c) the European Telecommunications Standards Institute (ETSI);

(d) the British Standards Institution (BSI).

(3A) In this regulation “ international standardising body ” has the same meaning as it has for the purposes of the Agreement on Technical Barriers to Trade, part of Annex 1A to the agreement establishing the World Trade Organisation signed at Marrakesh on 15 April 1994 (as modified from time to time).

(4) When considering whether the manner of publication of a reference is appropriate in accordance with paragraph (1)(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.

(5) Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with such technical specifications adopted by the other recognised standardisation bodies or by international standardising bodies as the Secretary of State considers to be relevant .

(6) The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph (1)(b).

(7) Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.

(8) In this regulation, a reference to a “ product ” is a reference to apparatus to which these Regulations apply.

(9) The Secretary of State may by regulation amend paragraph (3) to reflect any changes in the name or structure of the recognised standardisation bodies.

(10) Regulations made under paragraph (9) are to be made by statutory instrument.

(11) A statutory instrument containing regulations made under paragraph (9) is subject to annulment in pursuance of a resolution of either House of Parliament.

Section 3 Application

(1) Subject to paragraphs (2) to (4) and regulations 4 to 6, these Regulations apply to all equipment.

(2) These Regulations do not apply to—

(a) equipment to which the Radio Equipment Regulations 2017 apply ;

(b) aeronautical apparatus, parts and appliances as referred to in Regulation (EC) 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency and repealing Council Directive 91/670/EEC , Regulation (EC) No 1592/2002 and Directive 2004/36/EC ;

(c) radio equipment used by radio amateurs within the meaning of the Radio Regulations adopted in the framework of the Constitution of the International Telecommunication Union and the Convention of the International Telecommunication Union ;

(d) equipment the inherent nature and physical characteristics of which is such that—

(i) it is incapable of generating or contributing to electromagnetic emissions which exceed a level allowing radio and telecommunication equipment and other equipment to operate as intended; and

(ii) it operates without an unacceptable degradation in the presence of the electromagnetic disturbance normally consequent upon its intended use;

(e) custom built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes.

(3) These Regulations do not apply to kits of components to be assembled by radio amateurs and equipment made available on the market and modified by and for the use of radio amateurs.

(4) These Regulations do not apply to equipment covered by the Measuring Instruments Regulations 2016 .

(5) Each provision of these Regulations applies to equipment in so far as there are no specific provisions in ... any enactment governing the conformity of the equipment with the essential requirements, other than these Regulations . Where equipment is subject to essential requirements imposed by ... any enactment other than these Regulations , these Regulations only apply insofar as the equipment is not covered by the other provisions of that enactment .

Section 3A Disapplication where more specific obligations apply

(1) Each provision of these Regulations does not apply to equipment if, or to the extent that, paragraph (2) applies.

(2) This paragraph applies where any NI Protocol obligation, other than any obligation in relation to the Directive, applies to the equipment and makes more specific provision than the Directive in relation to the conformity of the equipment with the essential requirements.

Section 4 Application of safety legislation

Nothing in these Regulations affects the application of any enactment regulating the safety of equipment.

Section 5 Exhibition at trade fairs

Nothing in these Regulations prevents the display or demonstration at a trade fair, exhibition or similar event of equipment which does not comply with these Regulations provided that a visible sign clearly indicates that the equipment—

(a) is not in conformity with Part 2; and

(b) will not be made available on the market or put into service until it has been brought into conformity with Part 2.

Section 6 Making available or putting into service

Nothing in these Regulations prevents the making available on the market, or the putting into service in the United Kingdom, of equipment which is in conformity with Part 2 when the equipment is properly installed, maintained and used for its intended purpose.

Section 7 Essential requirements

A person must not make equipment available on the market or put equipment into service unless it complies with the essential requirements.

Section 8 Duty to ensure apparatus complies with the essential requirements

Before placing apparatus on the market, a manufacturer must ensure that it has been designed and manufactured in accordance with the essential requirements.

Section 9 Technical documentation and conformity assessment

Before placing apparatus on the market, a manufacturer must—

(a) carry out a relevant conformity assessment procedure in respect of the apparatus or have such a procedure carried out; and

(b) draw up—

(i) the technical documentation referred to in Schedule 2 (module A: internal production control) or Schedule 3 (module B: EU- type examination and module C: conformity to type based on internal production control); and

(ii) any other technical documentation required as part of the relevant conformity assessment procedure to demonstrate the means used by the manufacturer to ensure that the apparatus complies with the essential requirements.

Section 10 Declaration of conformity and UK marking

(1) Where the conformity of apparatus with the essential requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the apparatus on the market—

(a) draw up a declaration of conformity in accordance with regulation 41 ...; and

(b) affix the UK marking in accordance with regulation 42 ( UK marking).

(2) The manufacturer must keep the ... declaration of conformity up-to-date.

(3) Where apparatus is subject to more than one enactment requiring the drawing up of a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment concerned by its title.

Section 11 Retention of technical documentation and EU declaration of conformity

A manufacturer must keep the technical documentation and the EU declaration of conformity (as referred to in regulation 41) drawn up in respect of the apparatus for a period of 10 years beginning on the day on which the apparatus is placed on the market.

Section 12 Compliance procedures for series production

(1) A manufacturer of apparatus which is manufactured by series production must ensure that, before placing apparatus on the market, procedures are in place to ensure that any apparatus will be in conformity with Part 2.

(2) In doing so, the manufacturer must take adequate account of—

(a) any change in the design or characteristics; and

(b) any change in a designated standard or in another technical specification by reference to which the ... declaration of conformity was drawn up.

Section 13 Information identifying manufacturer

(1) Before placing apparatus onto the market, a manufacturer (“M”) must ensure that the following appear on the apparatus—

(a) a type, batch or serial number or an element which identifies M as the manufacturer of the apparatus;

(b) the name, registered trade name or registered trade mark of the manufacturer; and

(c) a postal address at which the manufacturer can be contacted.

(2) The manufacturer must include the relevant information specified in paragraph (1) on the packaging of the apparatus or in a document accompanying the apparatus where—

(a) due to the size or nature of the apparatus, it is not possible for the information in paragraph (1)(a) to appear on the apparatus; or

(b) it is not possible for the information in paragraphs (1)(b) or (1)(c) to appear on the apparatus.

(3) The postal address in paragraph (1)(c) must indicate a single point at which the manufacturer can be contacted.

(4) The information specified in paragraphs (1)(b) and (1)(c) must be clear, legible and in easily understandable English .

Section 14 Instructions and information

When placing apparatus on the market, a manufacturer must ensure that the apparatus is accompanied by instructions and the information referred to in regulation 36 (information concerning the use of apparatus) which are clear, legible and in clearly understandable English.

Section 15 Manufacturer's duty to take action in respect of apparatus placed on the market which is considered not to be in conformity

(1) A manufacturer who considers, or has reason to believe, that apparatus which the manufacturer has placed on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to—

(a) bring the apparatus into conformity;

(b) withdraw the apparatus; or

(c) recall the apparatus.

(2) Where the apparatus presents a risk, the manufacturer must immediately inform the market surveillance authority, ... giving details of, in particular—

(a) the respect in which the apparatus is considered not to be in conformity with Part 2; and

(b) any corrective measures taken.

Section 16 Provision of information and co-operation

(1) A manufacturer must, when requested by an enforcing authority and within such period as the authority may specify, provide the authority with all of the information and documentation necessary to demonstrate the conformity of the apparatus with Part 2.

(2) A request made under paragraph (1) must be accompanied by the reasons for making the request.

(3) The information and documentation referred to in paragraph (1)—

(a) may be provided in paper or electronic form; and

(b) must be in a language that can be easily understood by the enforcing authority.

(4) The manufacturer must, at the request of the enforcing authority, co-operate with the authority on any action taken to—

(a) evaluate the apparatus in accordance with regulation 56 (evaluation of apparatus presenting a risk);

(b) eliminate the risks posed by apparatus that the manufacturer has placed on the market.

Section 17 Prohibition on placing apparatus on the market which is not in conformity

An importer must not place apparatus on the market unless it is in conformity with the essential requirements.

Section 18 Requirements that must be satisfied before an importer places apparatus on the market

(1) Before placing apparatus on the market an importer must ensure that—

(a) a relevant conformity assessment has been carried out by the manufacturer;

(b) the manufacturer has drawn up the technical documentation;

(c) the apparatus—

(i) bears the UK marking; and

(ii) is accompanied by the required documents; and

(d) the manufacturer has complied with the requirements of regulation 13 (information identifying manufacturer).

(2) In paragraph (1)(c)(ii) “ required documents ” means any documents that are required to be provided pursuant to regulation 13(2).

Section 19 Duty not to place non-conforming apparatus on the market

(1) Where an importer considers or has reason to believe that apparatus is not in conformity with the essential requirements, the importer must not place the apparatus on the market.

(2) Where apparatus presents a risk, the importer must inform the manufacturer and the market surveillance authority of that risk.

Section 20 Information identifying importer

(1) An importer must, before placing apparatus on the market, ensure that the following appear on the apparatus ...—

(a) the name, registered trade name or registered trade mark of the importer; and

(b) a postal address at which the importer can be contacted.

(1A) Paragraph (1) does not apply where—

(a) either—

(i) it is not possible to set out the information referred to in paragraph (1) on the packaging of the apparatus or on the apparatus, or

(ii) the importer has imported the apparatus from an EEA state or Switzerland and places it on the market within the period of seven years beginning with IP completion day, and

(b) before placing the apparatus on the market, the importer sets out the information referred to in paragraph (1) in a document accompanying the apparatus.

(2) The information specified in paragraph (1) must be in a language which can be easily understood by end-users and the enforcing authority .

Section 21 Instructions and information

(1) When placing apparatus on the market, an importer must ensure that the apparatus is accompanied by instructions and the information referred to in regulation 36 (information concerning the use of apparatus) which are clear, legible and in easily understandable English .

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Section 22 Storage and transport

Where an importer has responsibility for apparatus, the importer must ensure that the conditions under which the apparatus is stored or transported do not jeopardise its conformity with the essential requirements.

Section 23 Importer's duty to take action in respect of apparatus placed on the market which is considered not to be in conformity

(1) An importer who considers or has reason to believe that apparatus that the importer has placed on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to—

(a) bring the apparatus into conformity;

(b) withdraw the apparatus; or

(c) recall the apparatus.

(2) Where the apparatus presents a risk, the importer must immediately inform the market surveillance authority ... of the risk, giving details of—

(a) the respect in which the apparatus is considered not to be in conformity with Part 2; and

(b) any corrective measures taken.

Section 24 Retention of technical documentation and EU declaration of conformity

An importer must keep the technical documentation and the EU declaration of conformity (as referred to in regulation 41) drawn up in respect of the apparatus for a period of 10 years beginning on the day on which the apparatus is placed on the market.

Section 25 Provision of information and co-operation

(1) An importer must, when requested by an enforcing authority and within such period as the authority may specify, provide the authority with all of the information and documentation necessary to demonstrate the conformity of the apparatus with Part 2.

(2) A request made under paragraph (1) must be accompanied by the reasons for making the request.

(3) The information and documentation referred to in paragraph (1) —

(a) may be provided in paper or electronic form; and

(b) must be in a language that can be easily understood by the enforcing authority.

(4) An importer must, at the request of the enforcing authority, co-operate with the authority on any action taken to—

(a) evaluate the apparatus in accordance with regulation 56 (evaluation of apparatus presenting a risk); and

(b) eliminate the risks posed by apparatus that importer has placed on the market.

Section 26 Duty to act with due care

When making apparatus available on the market, a distributor must act with due care to ensure that it is in conformity with Part 2.

Section 27 Making available on the market

(1) Before making apparatus available on the market, a distributor must verify that—

(a) the apparatus—

(i) bears the UK marking;

(ii) is accompanied by the required documents;

(iii) is accompanied by instructions and the information referred to in regulation 36 (information concerning the use of apparatus) which are clear, legible and in easily understandable English ;

(b) the manufacturer has complied with the requirements of regulation 13 (information identifying manufacturer); and

(c) the importer has complied with the requirements of regulation 20 (information identifying importer).

(2) In paragraph (1)(a)(ii) “ required documents ” means any documents that are required to be provided pursuant to regulation 13(2).

Section 28 Duty not to make non-conforming apparatus available on the market

(1) Where a distributor considers or has reason to believe that apparatus is not in conformity with the essential requirements, the distributor must not make the apparatus available on the market.

(2) Where apparatus presents a risk, the distributor must inform the manufacturer and the market surveillance authority of that risk.

Section 29 Storage and transport

Where a distributor has responsibility for apparatus, the distributor must ensure that the conditions under which the apparatus is stored or transported do not jeopardise its conformity with the essential requirements.

Section 30 Duty to take action in respect of apparatus placed on the market or made available on the market which is considered not to be in conformity

(1) A distributor who considers or has reason to believe that apparatus that the distributor has made available on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to—

(a) bring the apparatus into conformity;

(b) to withdraw the apparatus; or

(c) recall the apparatus.

(2) Where the apparatus presents a risk, the distributor must immediately inform the market surveillance authority ... of the risk, giving details of—

(a) the respect in which the apparatus is not considered to be in conformity with Part 2; and

(b) any corrective measures taken.

Section 31 Provision of information and co-operation

(1) A distributor must, when requested by an enforcing authority and within such period as the authority may specify, provide the authority with all of the information and documentation necessary to demonstrate the conformity of the apparatus with Part 2.

(2) A request referred to in paragraph (1) must be accompanied by the reasons for making the request.

(3) The information and documentation referred to in paragraph (1) —

(a) may be provided in paper or electronic form; and

(b) must be clear, legible and in easily understandable English .

(4) A distributor must, at the request of the enforcing authority, co-operate with the authority on any action taken to—

(a) evaluate the apparatus in accordance with regulation 56 (evaluation of apparatus presenting a risk); and

(b) eliminate the risks posed by apparatus that they have made available on the market.

Section 32 Cases in which the obligations of manufacturers apply to importers and distributors

An economic operator (“A”) who would, but for this regulation, be considered an importer or distributor, is to be considered a manufacturer for the purposes of these Regulations and is subject to the obligations of a manufacturer under Part 2, where A—

(a) places apparatus on the market under A's own name or trademark; or

(b) modifies apparatus already placed on the market in such a way that it may affect whether the apparatus is in conformity with Part 2.

Section 33 Identification of economic operators

(1) An economic operator (“E”), who receives a request in relation to apparatus from the market surveillance authority before the end of the relevant period, must, within such period as the authority may specify, identify to the authority—

(a) any other economic operator who has supplied E with apparatus; and

(b) any other economic operator to whom E has supplied apparatus.

(2) The relevant period is—

(a) in the case of paragraph (1)(a), the period of 10 years beginning on the day on which E was supplied with the apparatus;

(b) in the case of paragraph (1)(b), the period of 10 years beginning on the day on which E supplied the apparatus.

Section 34 Translation of EU declaration of conformity

(1) Before placing apparatus on the market or making apparatus available on the market, an economic operator must ensure that the EU declaration of conformity is prepared in, or translated into, the language required by the relevant state in which it is to be placed on the market or made available on the market.

(2) Where the apparatus is to be placed on the market or made available on the market in Northern Ireland , the language referred to in paragraph (1) is English.

Section 35 Prohibition on improper use of UK marking

(1) An economic operator must not affix the UK marking to apparatus unless—

(a) that economic operator is the manufacturer of the apparatus; and

(b) the conformity of apparatus with the essential requirements has been demonstrated by a relevant conformity procedure.

(2) An economic operator must not affix a marking (other than UK marking) to equipment which purports to attest to the conformity of the equipment with the essential requirements.

(3) An economic operator must not affix to equipment a marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the UK marking.

(4) An economic operator must not affix to equipment any other marking if the visibility, legibility and meaning of the UK marking would be impaired as a result.

Section 36 Information concerning the use of apparatus

(1) A person who places apparatus on the market must provide with the apparatus—

(a) information on any specific precautions which must be taken during assembly, installation, maintenance or use to ensure that the apparatus will be in conformity with the requirements of paragraph 1 of Schedule 1 when it is put into service;

(b) information on the restrictions on the use of the apparatus in residential areas where the conformity of the apparatus with paragraph 1 of Schedule 1 cannot be ensured; and

(c) information required to enable the apparatus to be used in accordance with its intended purpose.

(2) Where appropriate, the information referred to in paragraph (1)(b) must also be included on the packaging of the apparatus.

Section 37 Fixed installations

(1) Subject to paragraph (2), apparatus that has been made available on the market and which can be incorporated into a fixed installation is subject to all of the relevant provisions for apparatus in these Regulations.

(2) Where apparatus is intended for incorporation into a particular fixed installation and is not otherwise made available on the market, the requirements of Part 2 and Part 3 do not apply.

(3) A person who places apparatus of the type referred to in paragraph (2) on the market must provide information with the apparatus which—

(a) identifies the fixed installation in which it is to be incorporated and the electromagnetic compatibility characteristics of that fixed installation;

(b) sets out the precautions to be taken when the apparatus is incorporated into the fixed installation to ensure the conformity of the installation with Part 2;

(c) includes the information referred to in—

(i) regulation 13 (information identifying manufacturer); and

(ii) if relevant, regulation 20 (information identifying importer).

(4) The good engineering practices referred to in paragraph 2 of Schedule 1 must be documented and the documentation held by the person who installed the fixed installation during the period of operation of the fixed installation.

(5) The person referred to in paragraph (4) must ensure that the documentation can be made available to the relevant national authorities upon request during the period of operation of that fixed installation.

(6) Where the enforcing authority has received complaints about disturbances being generated by the fixed installation or has reason to believe that a fixed installation may not be in conformity with these Regulations, the enforcing authority may request evidence of conformity of the fixed installation and may initiate an evaluation of the fixed installation.

(7) Where the enforcing authority considers that the evaluation referred to in paragraph (6) has established that the fixed installation is not in conformity with these Regulations, the enforcing authority must ensure that appropriate measures are taken to ensure that the fixed installation is brought into conformity with the essential requirements in Schedule 1.

(8) The person referred to in paragraph (4) is responsible for ensuring that the installation is in conformity with the relevant essential requirements.

Section 38 Appointment of an authorised representative

(1) A manufacturer may, by written mandate, appoint a person established in the United Kingdom as their authorised representative to perform specified tasks on the manufacturer's behalf.

(2) The mandate must allow the authorised representative to do at least the following in relation to apparatus covered by the mandate—

(a) perform the manufacturer's obligations under regulation 11 (retention of technical documentation and ... declaration of conformity);

(b) perform the manufacturer's obligations under regulation 16 (provision of information and co-operation).

(3) The mandate must not include the obligations contained in—

(a) regulation 8 (duty to ensure apparatus complies with the essential requirements); or

(b) regulation 9 (technical documentation and conformity assessment).

(4) A manufacturer who has appointed an authorised representative to perform, on the manufacturer's behalf, a task under these Regulations remains responsible for the proper performance of that task.

(5) An authorised representative must comply with all the duties imposed on the manufacturer in relation to each obligation under these Regulations that the representative is appointed by the mandate to perform and accordingly—

(a) as far as those duties are concerned, a reference in these Regulations to the manufacturer (except in this regulation) is to be taken as including a reference to the authorised representative; and

(b) if the authorised representative contravenes or fails to comply with any of those duties, the authorised representative may be proceeded against as though the authorised representative were the manufacturer.

Section 38A Obligations which are met by complying with obligations in the Directive

(1) In this regulation—

(a) any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive;

(b) “ CE marking ” has the meaning given to it in Article 3(25);

(c) “ harmonised standard ” has the meaning given to it in Article 3(17).

(2) Paragraph (3) applies where, before placing apparatus on the market, the manufacturer—

(a) ensures that the apparatus has been designed and manufactured in accordance with the essential requirements set out in Annex I;

(b) draws up the technical documentation relating to such apparatus referred to in Annex III;

(c) ensures that the relevant conformity assessment procedure relating to such apparatus referred to in Article 14 has been carried out;

(d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedure are prepared in or translated into English;

(e) affixes a CE marking, in accordance with Articles 16 and 17(1) to (2);

(f) draws up an EU declaration of conformity, in accordance with Article 15; and

(g) ensures that the EU declaration of conformity is prepared in or translated into English.

(3) Where this paragraph applies—

(a) the requirements of regulations 8, 9, 10(1)(a) and (b) and (3) and 42(1) are to be treated as being satisfied;

(b) regulations 2(2)(a), 10(2), 11, 12, 38(2) and 35 apply subject to the modifications in paragraph (8);

(c) Part 3 does not apply; and

(d) regulation 59 does not apply.

(4) Paragraph (5) applies where, before placing a category apparatus on the market, the importer ensures that—

(a) the relevant conformity assessment procedure referred to in Article 14 has been carried out;

(b) the manufacturer has drawn up the technical documentation referred to in Annex III; and

(c) the apparatus bears the CE marking.

(5) Where this paragraph applies—

(a) the requirements of regulation 18(a) to (c) are to be treated as being satisfied; and

(b) regulations 2(2)(a), 17, 19(1), 22 and 24 apply subject to the modifications in paragraph (8).

(6) Paragraph (7) applies where, before making apparatus available on the market, a distributor ensures that the apparatus bears the CE marking.

(7) Where this paragraph applies—

(a) regulation 27(1)(a) is to be treated as being satisfied; and

(b) regulations 2(2)(a), 28(1) and 29 apply subject to the modifications in paragraph (10).

(8) The modifications referred to in sub-paragraphs (3)(b), (5)(b) and (9)(b) are that—

(a) any reference to “declaration of conformity” is to be read as a reference to the EU declaration of conformity;

(b) any reference to “UK marking” is to be read as a reference to the CE marking;

(c) any reference to “essential requirements” is to be read as a reference to the essential ... requirements referred to in Annex I;

(d) any reference to “designated standard” is to be read as a reference to a harmonised standard;

(e) any reference to “relevant conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedures referred to in Article 14;

(f) any reference to “ technical documentation ” is a reference to the technical documentation referred to in Annex III.

Section 38B Further use of the UK marking

(1) In this regulation—

(a) any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive;

(b) “ harmonised standard ” has the meaning given to it in Article 3(17).

(2) Paragraph (3) applies where, before placing apparatus on the market, the manufacturer—

(a) ensures that the apparatus has been designed and manufactured in accordance with the essential requirements set out in Annex I;

(b) draws up the technical documentation relating to such apparatus referred to in Annex III;

(c) ensures that the relevant conformity assessment procedure relating to such apparatus referred to in Article 14 has been carried out; and

(d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedure are prepared in or translated into English.

(3) Where this paragraph applies—

(a) the requirements of regulations 8 and 9 are to be treated as being satisfied;

(b) except for regulations 41 and 42, Part 3 does not apply;

(c) regulations 2(2)(a), 7, 11, 12, 17 to 19, 22, 24, 28, 29, 35(1), 41 and 59 apply subject to the modifications in paragraph (4);

(d) regulation 10 and Schedule 4 apply subject to the modifications in paragraphs (4) and (5);

(e) regulations 36 and 37 apply subject to the modifications in paragraph (6).

(4) The modifications referred to in paragraph (3)(c) and (d) are that—

(a) any reference to “essential requirements” is to be read as a reference to the essential requirements set out in Annex 1;

(b) any reference to “designated standard” is to be read as a reference to “harmonised standard”;

(c) any reference to “relevant conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedure referred to in Article 14;

(d) any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Annex III.

(5) The modifications referred to in paragraph (3)(d) are that—

(a) in regulation 10, the reference to “enactment” is to be read as including the Directive;

(b) in Schedule 4—

(i) in paragraph 5, the reference to “statutory requirements” is to be read as including the Directive;

(ii) in paragraph 7, the reference to “approved body” is to be read as a reference to the conformity assessment body that undertook any conformity assessment procedure in accordance with Article 14.

(6) The modifications referred to in paragraph (3)(e) are that—

(a) in regulation 36 any reference to “paragraph 1 of Schedule 1” is to be read as a reference to paragraph 1 of Annex I;

(b) in regulation 37 any reference to “paragraph 2 of Schedule 1” is to be read as a reference to paragraph 2 of Annex I.

Section 38C Qualifying Northern Ireland Goods

(1) Where paragraph (2) applies, apparatus is to be treated as being in conformity with Part 2.

(2) This paragraph applies where—

(a) apparatus—

(i) is in conformity with Part 2, as that Part applies in Northern Ireland; and

(ii) is qualifying Northern Ireland goods; and

(b) an importer has complied with the obligations set out in paragraph (3).

(3) The obligations referred to in paragraph (2)(b) are that, before placing the apparatus on the market, the importer—

(a) complies with regulation 20;

(b) ensures that—

(i) the relevant conformity assessment procedure has been carried out in relation to the apparatus;

(ii) the manufacturer has drawn up the technical documentation; and

(iii) the apparatus bears the CE marking.

(4) In this regulation—

“ CE marking ” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland;

“ qualifying Northern Ireland goods ” has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018;

“ relevant conformity assessment procedure ” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland;

“ technical documentation ” means the documentation a manufacturer must draw up, in accordance with regulation 9(b), as it applies in Northern Ireland.

Section 39 Presumption of conformity

(1) Equipment which is in conformity with a designated standard (or part of such a standard) ... is to be presumed to be in conformity with the essential requirements covered by that standard (or that part of that standard).

(2) The presumption in paragraph (1) is rebuttable.

Section 40 Conformity assessment procedures

(1) Subject to paragraph (2), the manufacturer must demonstrate the conformity of the apparatus with the essential requirements by means of either—

(a) the procedure set out in Schedule 2 (Module A: internal production control); or

(b) the procedures set out in Schedule 3 (Module B: EU type examination followed by Module C: conformity to type based on internal production control).

(2) The manufacturer may choose to demonstrate the conformity of apparatus with some of the essential requirements by following the procedure referred to in paragraph (1)(b) provided that the procedure referred to in paragraph (1)(a) is followed for the remaining essential requirements.

Section 41 Declaration of conformity

The ... declaration of conformity for apparatus must—

(a) state that the fulfilment of the essential requirements has been demonstrated in respect of the apparatus;

(b) contain the elements of the relevant conformity assessment procedure or procedures followed in respect of the apparatus; and

(c) have the model structure set out in Schedule 4.

Section 42 UK marking

(1) The UK marking must be affixed visibly, legibly and indelibly—

(a) to the apparatus;

(b) to its data plate; or

(c) where paragraph (1A) applies, to—

(i) a label affixed to the apparatus or its data plate; or

(ii) to a document accompanying the apparatus.

(1A) For a period of seven years beginning with IP completion day, the UK marking may be affixed to—

(a) a label affixed to the apparatus or its data plate; or

(b) a document accompanying the apparatus.

(2) Where paragraph (1A) does not apply and it is not possible or warranted, on account of the nature of the apparatus, to affix the UK marking in accordance with paragraph (1), the CE marking must be affixed to—

(a) the packaging; and

(b) the accompanying documents.

Section 42A UK(NI) indication

(1) Where the CE marking is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the apparatus, in accordance with this regulation.

(2) The UK(NI) indication must be affixed—

(a) visibly, legibly and indelibly; and

(b) before apparatus is placed on the market in Northern Ireland.

(3) The UK(NI) indication must accompany the CE marking, wherever that is affixed in accordance with regulation 42.

(4) The UK(NI) indication must be affixed by—

(a) the manufacturer; or

(b) the manufacturer's authorised representative.

(5) When placing apparatus on the market in Northern Ireland, an importer must ensure that the manufacturer has complied with their obligations under this regulation.

Section 42B Register of UK notified bodies

(1) The Secretary of State must ensure that—

(a) each notified body established in the United Kingdom is assigned an identification number; and

(b) there is a register of—

(i) notified bodies established in the United Kingdom;

(ii) their notified body identification number;

(iii) the activities for which they have been notified;

(iv) any restrictions on those activities.

(2) The Secretary of State must ensure that the register referred to in paragraph (1) is maintained and made publicly available.

(3) The Secretary of State may authorise the United Kingdom Accreditation Service to compile and maintain the register in accordance with paragraph (1)(b).

Section 43 Approved bodies

(1) An approved body is a conformity assessment body which—

(a) has been approved by the Secretary of State pursuant to the procedure set out in regulation 44 (approval of conformity assessment bodies); or

(b) immediately before IP completion day was a notified body in respect of which the Secretary of State had taken no action under regulation 49(1) or (2) as they had effect immediately before IP completion day to suspend or withdraw the body's status as a notified body.

(2) Paragraph (1) has effect subject to regulation 47 (restriction, suspension or withdrawal of approval).

(3) In this Part—

“ notified body ” means a body—

which the Secretary of State had before IP completion day notified to the European Commission and the member State of the European Union, in accordance with Article 20 of the Directive; and

in respect of which no objections had been raised, as referred to in regulation 43(1)(b), as it had effect immediately before IP completion day;

“ approved body requirements ” means the requirements set out in Schedule 5.