The Radio Equipment and Telecommunications Terminal Equipment Regulations 2000

• Citation: S.I. 2000/730
• Sections: 102

Section 1 Citation, commencement, revocations and disapplications

(1) These Regulations may be cited as the Radio Equipment and Telecommunications Terminal Equipment Regulations 2000 and shall come into force on 8th April 2000.

(2) The following Orders and Regulations are hereby revoked:

Telecommunication Apparatus (Advertisements) Order 1982

Telecommunication Apparatus (Advertisements) Order 1985

Telecommunication Apparatus (Advertisements) (Amendments) Order 1985

Telecommunication Apparatus (Marking and Labelling) Order 1982

Telecommunication Apparatus (Marking and Labelling) Order 1985

Telecommunication Apparatus (Marking and Labelling) (Amendment) Order 1985

Telecommunication Apparatus (Bell Noise Labelling) Order 1985

Telecommunication Apparatus (Approval Fees) (British Approvals Board for Telecommunications) Order 1990

Telecommunication Apparatus (Approval Fees) (British Approvals Board for Telecommunications) Order 1992

Telecommunications Terminal Equipment Regulations 1992

Telecommunications Terminal Equipment (Amendment and Extension) Regulations 1994

Telecommunications Terminal Equipment (Amendment) Regulations 1995

(3) Sections 22 and 84 of the Act, ... ... shall cease to apply to apparatus covered by these Regulations.

Section 2 Interpretation

(1) In these Regulations (except in Schedule 9)—

“the Act” means the Telecommunications Act 1984 ;

“ active implantable medical device ” shall have the meaning in Article 1 of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices ;

“ apparatus ” means any equipment that is either radio equipment or telecommunications terminal equipment or both;

“ the CE marking ” has the meaning given in regulation 10;

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

“ a component or a separate technical unit of a vehicle ” shall have the meaning in Article 2 of Council Directive 92/61/EEC ;

“the Directive” means Directive 1999/5/EC of the European Parliament and of the Council on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity ;

“the Director” means the Director General of Telecommunications appointed under section 1 of the Act;

“ enforcement authority ” has the meaning given in paragraphs 1 and 2 of Schedule 9;

“ equipment class ” means a class identifying particular types of apparatus which under the Directive are considered similar and those interfaces for which the apparatus is designed. Apparatus may belong to more than one equipment class;

“ harmful interference ” means interference which endangers the functioning of a radio navigation service or of other safety services or which otherwise seriously degrades, obstructs or repeatedly interrupts a radio communications service operating in accordance with the applicable Community or national regulations;

“ harmonised standard ” means a technical specification adopted by a recognised standards body under a mandate from the Commission in conformity with the procedures laid down in Directive 98/34/EC of the European Parliament and of the Council for the purpose of establishing a European requirement, compliance with which is not compulsory;

“ interface ” means either or both of—

a network termination point which is a physical connection point at which a user is provided with access to public telecommunications network, and

an air interface specifying the radio path between radio equipment

and their technical specifications;

“ medical device ” shall have the meaning in Article 1 of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices ;

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

“ public telecommunications networks ” means telecommunications networks used wholly or partly for the provision of publicly available telecommunications services;

“ radio equipment ” means a product, or a relevant component thereof, capable of communication by means of the emission and/or reception of radio waves utilising the spectrum allocated to terrestrial/space radio communication;

“ radio waves ” means electromagnetic waves of frequencies from 9 kHz to 3,000 GHz, propagated in space without artificial guide;

“ responsible person ” means the manufacturer of apparatus or his authorised representative within the European Union , or any other person who places the apparatus on the market;

“ technical construction file ” means a file describing the apparatus and providing information and explanations as to how the essential requirements (within the meaning of regulation 4) applicable to the apparatus have been met;

“ telecommunications terminal equipment ” means a product enabling communication, or a relevant component thereof, which is intended to be connected directly or indirectly by any means whatsoever to interfaces of public telecommunications networks;

and any other expression used in these Regulations which is also used in the Directive has the same meaning in these Regulations as it has in the Directive.

(2) For the purposes of these Regulations, unless the context otherwise requires, a reference to a numbered regulation or Schedule is a reference to the regulation or Schedule so numbered in these Regulations and a reference—

(i) in a regulation to a paragraph is a reference to a paragraph in that regulation;

(ii) to an Annex is a reference to an Annex of the Directive.

(3) For the purposes of these Regulations, Annexes I, II, III, IV, V, VI and VII are respectively set out in Schedules 1, 2, 3, 4, 5, 6 and 7, and a reference to a paragraph in an Annex is a reference to a paragraph in that Annex as set out in the respective Schedule.

(4) Except for the references to the European Union in the definition of “the Commission” and in relation to the Official Journal, a reference to the European Union includes a reference to the EEA , and a reference to a member State includes a reference to an EEA State: for this purpose—

(a) the “ EEA ” means the European Economic Area;

(b) an “ EEA State” means a State which is a contracting party to the EEA Agreement; and

(c) the “ EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992 as adjusted by the Protocol signed at Brussels on 17th March 1993 .

Section 3 Scope and Exclusions

(1) Subject to paragraphs (4) and (5), these Regulations shall apply to all apparatus.

(2) Where apparatus incorporates, as an integral part or as an accessory—

(a) a medical device; or

(b) an active implantable medical device,

the apparatus shall be governed by these Regulations without prejudice to the application of Council Directive 93/42/EEC of 14 June 1993 ; or Council Directive 90/385/EEC of 20 June 1990 ; or the Medical Devices Regulations 1994 ; or the Active Implantable Medical Devices Regulations 1992 .

(3) Where apparatus constitutes a component or a separate technical unit of a vehicle, the apparatus shall be governed by these Regulations without prejudice to the application of Council Directive 72/245/EEC of 20 June 1972 ; or Council Directive 92/61/EEC of 30 June 1992 ; or the Motor Vehicles (Type Approval) Regulations 1980 ; or the Motorcycle (EC Type Approval) Regulations 1995 .

(4) These Regulations shall not apply to apparatus exclusively used for the purposes of public security, defence, State security (including the economic well-being of the State) or the activities of the State in the area of criminal law.

(5) These Regulations shall not apply to equipment listed in Schedule 1.

Section 4 Essential Requirements

(1) Apparatus when properly installed and maintained and used for its intended purpose shall satisfy the essential requirements set out in this regulation.

(2) The following essential requirements shall apply to all apparatus:

(a) the protection of the health and safety of the user and any other person, including the objectives with respect to safety requirements contained in Council Directive 73/23/EEC (but as if there were no voltage limit);

(b) the protection requirements with respect to electromagnetic compatibility contained in Council Directive 89/336/EEC ;

(3) In addition, radio equipment shall be so constructed that it effectively uses the spectrum allocated to terrestrial/space radio communication and orbital resources so as to avoid harmful interference.

(4) When a measure has been adopted by the Commission pursuant to Articles 3.3, 6.2 and 15 of the Directive and published in the Official Journal of the European Union determining that apparatus shall be so constructed that—

(a) it interworks via networks with other apparatus and that it can be connected to interfaces of the appropriate type throughout the European Union ; or that

(b) it does not harm the network or its functioning nor misuse network resources, thereby causing an unacceptable degradation of service; or that

(c) it incorporates safeguards to ensure that the personal data and privacy of the user and of the subscriber are protected; or that

(d) it supports certain features ensuring avoidance of fraud; or that

(e) it supports certain features ensuring access to emergency services; or that

(f) it supports certain features in order to facilitate its use by users with a disability,

apparatus within the scope of that measure shall meet the requirements of that measure from the date specified in that measure.

Section 5 General duty relating to the placing on the market and putting into service of apparatus

(1) Subject to paragraph (4) and regulations 6, 7 and 8, no person shall place on the market or put into service any apparatus unless the requirements of paragraph (2) and (in the case of radio equipment) the requirements of paragraph (3) have been complied with in relation to it.

(2) The requirements in respect of any apparatus are that:

(a) it satisfies the essential requirements set out in regulation 4: and without prejudice to other means of complying for the purpose of satisfying those requirements, where a harmonised standard covers one or more of the relevant essential requirements, any apparatus or part thereof constructed in accordance with that harmonised standard or part thereof shall be presumed to comply with that or, as the case may be, those essential requirements;

(b) the information has been provided in accordance with regulation 11;

(c) the appropriate conformity assessment procedures in respect of the apparatus have been carried out in accordance with regulation 9;

(d) the requirements of regulation 10 and Schedule 7 (CE and other marking) have been complied with;

(e) a declaration of conformity has been drawn up in respect of it by the manufacturer of the apparatus or other responsible person in accordance with Schedule 2, 3, 4 or 5.

(3) In respect of radio equipment using frequency bands whose use is not harmonised throughout the European Union it is also a requirement that notification of intention to place it on the market shall have been given in accordance with regulation 12.

(4) Paragraph (1) does not prohibit the putting into service of apparatus in relation to which the requirements of paragraphs (2)(b), (c), (d) and (e) have not been complied with.

Section 6 Exceptions in respect of placing on the market and putting into service

(1) For the purposes of regulation 5, apparatus shall not be regarded as being placed on the market where that apparatus—

(a) is intended to be exported to a country outside the European Union ; or

(b) is imported into the European Union for re-export to a country outside the European Union ; or

(c) is transferred from the manufacturer in a third country to his authorised representative established within the European Union who is responsible on behalf of the manufacturer for ensuring compliance with the Directive; or

(d) is transferred to a manufacturer for further processing (for example, to modify the product or to integrate it into another product, or to put his own name on the product);

save that this paragraph shall not apply if the CE marking, or any inscription liable to be confused therewith, is affixed thereto.

(2) Subject to paragraph (3), no offence under the Act or the Wireless Telegraphy Acts 1949 to 1967, nor any offence of incitement to commit such an offence, shall be committed by reason only that apparatus which does not comply with these Regulations is displayed at a trade fair, exhibition or demonstration if a notice is displayed in relation to the apparatus to the effect

(a) that it does not satisfy the provisions of these Regulations; and

(b) that it may not be placed on the market or put into service until those provisions are satisfied by a responsible person.

(3) Paragraph (2) does not apply in any case in which radio equipment is switched on and thereby causes harmful interference or endangers public health.

(4) The Secretary of State and the Director shall so exercise their respective functions under Part VI of the Act and the Wireless Telegraphy Acts 1949 to 1967 that the putting into service of radio equipment which complies with these Regulations is restricted only for reasons related to the effective and appropriate use of the radio spectrum, avoidance or harmful interference of public health.

Section 7 The right to connect

(1) Operators of public telecommunications networks

(a) shall connect or permit the connection, at an interface, of any telecommunications terminal equipment which meets the requirements of regulation 4 or is equipment which was placed on the market before 8th April 2001 and complied with the provisions of Directive 98/13/ EC , the Telecommunication Terminal Equipment Regulations 1992 or section 22 or 84 of the Telecommunications Act 1984;

(b) shall not discontinue such connection lawfully made of any such equipment.

(2) No apparatus is required under sub-paragraphs (1)(a) and (b) or otherwise to be, or to be permitted to be, connected or kept connected if that apparatus

(a) met the requirements of regulation 4 at the time when the connection was made but no longer does so;

(b) was placed on the market before 8th April 2001 and complied with the provisions of Directive 98/13/ EC , the Telecommunication Terminal Equipment Regulations 1992 or section 22 or 84 of the Telecommunications Act 1984 at the time when the connection was made but no longer does so;

(c) causes serious damage to a network or harmful radio interference or harm to the network or its functioning; and the operator may refuse connection of that apparatus, disconnect that apparatus or withdraw that apparatus from service provided the operator at the earliest practical opportunity informs the Secretary of State and the Director of its action; or

(d) is, in case of emergency, required to be disconnected to protect the network, provided that

(i) the user may be offered, without delay and without costs, an alternative solution; and

(ii) the operator immediately informs the Secretary of State and the Director.

(3) In any case in which a public telecommunications operator

(a) refuses connection of apparatus declared to be compliant with the provisions of the Directive; or

(b) disconnects such apparatus; or

(c) withdraws it from service

the Secretary of State and the Director may, if they are of the opinion that the apparatus would not cause serious damage to a network or harmful interference or harm to the network or its functioning, require the operator to provide connection, reconnect the apparatus or restore it to service (as the case may be).

Section 8 Transitional provisions in respect of placing on the market and putting into service

Notwithstanding the provisions of regulation 5, apparatus may be placed on the market before 8 April 2001, and apparatus so placed on the market may be put into service, if (in either case) it is in accordance with the provisions of Council Directive 98/13/EC , the Telecommunications Terminal Equipment Regulations 1992 , or section 22 or 84 of the Act.

Section 9 Conformity assessment procedures for apparatus

(1) For the purposes of regulation 5(2)(c), the appropriate conformity assessment procedure for apparatus shall, subject to paragraph (2), be chosen from the procedures set out in Schedules 2, 3, 4 and 5 as follows:

(a) for telecommunications terminal equipment which does not make use of the spectrum allocated to terrestrial/space radio communications and for the receiving parts of radio equipment, the conformity assessment procedures which may be chosen from are those laid down in Schedules 2, 4 and 5;

(b) where radio equipment is not within the scope of subparagraph (a) above and the manufacturer has fully applied harmonised standards, the conformity assessment procedures which may be chosen from are those laid down in Schedules 3, 4 and 5;

(c) where radio equipment is not within the scope of subparagraph (a) above and the manufacturer has not applied harmonised standards or has applied them only in part, the conformity assessment procedures which may be chosen from are those laid down in Schedules 4 and 5.

(2) As an alternative to the procedures set out in paragraph (1), compliance of the apparatus with the essential requirements identified in—

(a) regulation 4(2)(a) may be demonstrated by using the procedures specified in Council Directive 73/23/EEC , and

(b) regulation 4(2)(b) may be demonstrated by using the procedures specified in Article 10(1) and 10(2) of Directive 89/336/EEC ,

where apparatus is within the scope of either of those Directives.

(3) Any technical documentation or other information in relation to apparatus required to be retained under the conformity assessment procedure used shall be retained by the person specified in that respect in that conformity assessment procedure for the appropriate period specified in that procedure.

Section 10 CE marking

(1) In these Regulations, “ the CE marking ” means a marking in the form set out in paragraph 1 of Annex VII as set out in Schedule 7.

(2) The CE marking shall be accompanied by—

(a) the identification number of all notified bodies used where the conformity assessment procedure is carried out in accordance with Schedule 3, 4 or 5;

(b) in the case of radio equipment, the equipment class identifier where one has been assigned.

(3) There shall be marked on the apparatus

(a) the name of the responsible person;

(b) the type identification of the apparatus; and

(c) the batch or serial number assigned to the apparatus by the manufacturer.

(4) Where apparatus is subject to other directives concerning other aspects and which also provide for the affixing of the CE marking, the markings shall indicate that the apparatus in question is also presumed to conform to the provisions of those other directives. However, should one or more of those directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate conformity to the provisions only of those directives applied by the manufacturer. In this case the particulars of those directives, as published in the Official Journal, must be given in the documents, notices or instructions required by those directives and accompanying such products.

(5) Subject to paragraph (6) any other marking may be affixed to apparatus provided that the visibility and legibility of the CE marking is not thereby reduced.

(6) The affixing of markings on apparatus which are likely to mislead third parties as to the meaning or form of the CE marking is prohibited.

Section 11 Information accompanying apparatus

There shall be prominently displayed on or accompany the apparatus information for the user as follows:

(a) in the case of all apparatus—

(i) its intended use; and

(ii) a declaration of its conformity to the applicable essential requirements;

(b) in the case of radio equipment, sufficient information on the packaging and the instructions for use to identify the Member States or the geographical area within the Member States where it is intended to be used; and marking on the apparatus as provided for in paragraph 5 of Schedule 7 shall be used when appropriate to alert the user that restrictions or requirements for authorisation of the use of the radio equipment apply in certain Member States;

(c) in the case of telecommuncations terminal equipment, sufficient information to identify the interfaces of public telecommunications networks to which the equipment is intended to be connected.

Section 12 Notice to be given to the OFCOM before placing radio equipment on the market

(1) The responsible person shall, not less than four weeks before the date it is intended to place on the market in the United Kingdom radio equipment using frequency bands whose use is not harmonised throughout the European Union , give notice in writing to the OFCOM which contains—

(a) such information as is required by the OFCOM about the radio characteristics of the equipment, in particular its frequency bands, channel spacing, type of modulation and RF power; and

(b) where appropriate the identification number of all the notified bodies used.

(2) Notice given under paragraph (1) shall be effective in respect of all items of equipment, whether placed on the market at the same time or at different times, which are in all material respects identical to each other.

Section 13 Publication of and access to information

(1) Subject to paragraph (7) below, each public telecommunications network operator shall, in relation to all interfaces in use by the operator at the time this regulation comes into force, notify such interfaces to the Director and publish within 90 days of this regulation coming into force, in an accurate and adequate manner, the technical specifications of the interfaces in accordance with paragraph (5) below.

(2) Before services are provided through any interface which is not published under paragraph (1) above the public telecommunications network operator shall

(a) notify such interface to the Director; and

(b) publish the technical specification of the interface in an accurate and adequate manner and in accordance with paragraph (5) below.

(3) Where any interface to which paragraph (1) or (2) above applies is modified by the public telecommunications network operator

(a) he shall notify such modification to the Director and publish such modification in an accurate and adequate manner and in accordance with paragraph (5) below; and

(b) the modification shall include any change in the description of any interface which may affect the maintenance of effective interoperability of services by means of the interface.

(4) Where any interface to which paragraph (1) or (2) above applies is withdrawn, the public telecommunications network operator shall notify such withdrawal to the Director and publish such withdrawal in accordance with paragraph (5) below.

(5) The requirements as to publication are that

(a) the interface specification published shall

(i) be in sufficient detail to permit the design of telecommunications terminal equipment capable of utilising all services provided through the corresponding interface;

(ii) detail any changes in existing interfaces; and

(iii) include, inter alia, all the information necessary to allow manufacturers to carry out, at their choice, the relevant tests for the essential requirements applicable to the telecommunications terminal equipment; and

(b) the interface specification shall be made readily available by the public telecommunications network operator.

(6) If, following any representation made to it OFCOM concludes that any interface specification contains insufficient information for the purpose of paragraph (5), OFCOM may direct the public telecommunications network operator to

(a) amend the interface specification in order to remedy the defect; and

(b) publish the amended interface specification in accordance with the provisions of paragraph (5).

(7) Nothing in this regulation shall require the public telecommunications network operator to publish or send to the Director information which it has already published or sent to the Director.

Section 14 Notified bodies

For the purposes of these Regulations, a notified body is a body which has been—

(a) appointed as a notified body pursuant to regulation 15;

(b) appointed by a Member State other than the United Kingdom and notified to the Commission and the other Member States pursuant to Article 11 of the Directive; or

(c) recognised for the purpose of carrying out those functions by inclusion in a mutual recognition agreement relating to the Directive or a similar agreement (including a Protocol to the Europe Agreement, or other Agreement, on Conformity Assessment and Acceptance of Industrial Products) which has been concluded between the European Union and a State other than an EEA State.

Section 15 Notified bodies appointed by the Secretary of State

(1) The Secretary of State, applying the criteria in Schedule 6 and such other criteria as he thinks fit, may from time to time appoint such persons as he thinks fit to be notified bodies.

(2) An appointment—

(a) may relate to such descriptions of apparatus as the Secretary of State may from time to time determine;

(b) may be made subject to such conditions as the Secretary of State may from time to time determine, and such conditions may include conditions which are to apply upon or following termination of the appointment;

(c) shall, without prejudice to the generality of subparagraph (b) and subject to paragraph (4), require the appointed body to carry out the procedures and specific tasks for which it has been appointed including (where so provided as part of those procedures) surveillance to ensure that the responsible person duly fulfils the obligations arising out of the relevant conformity assessment procedure;

(d) shall be terminated upon 90 days' notice in writing given to the Secretary of State by the notified body; and

(e) may be terminated if it appears to the Secretary of State that any of the conditions of the appointment are not complied with.

(3) Subject to paragraph (2)(d) and (e), an appointment under this regulation may be for the time being or for such period as may be specified in the appointment.

(4) A notified body appointed by the Secretary of State shall not be required to carry out the functions referred to in paragraph (2)(c) if—

(a) the documents submitted to it in relation to carrying out such functions are not in English or another language acceptable to that body; or

(b) the responsible person has not submitted with his application the amount of the fee which the body requires to be submitted with the application pursuant to regulation 16.

(5) If for any reason the appointment of a notified body is terminated under this regulation, the Secretary of State may—

(a) give such directions (either to the body the subject of the termination or to another notified body) for the purpose of making such arrangements for the determination of outstanding applications as he considers appropriate; and

(b) without prejudice to the generality of the foregoing, authorise another notified body to take over its functions in respect of such cases as he may specify.

Section 16 Fees

(1) A notified body appointed by the Secretary of State may charge such fees in connection with, or incidental to, the performance of its functions as it may determine: provided that such fees shall not exceed the sum of the following—

(a) the costs incurred or to be incurred by the notified body in performing the relevant function; and

(b) an amount on account of profit which is reasonable in the circumstances having regard to—

(i) the character and extent of the work done or to be done by the body on behalf of the applicant; and

(ii) the commercial rate normally charged on account of profit for that work or similar work.

(2) A notified body may require the payment of fees or a reasonable estimate thereof in advance of carrying out the work requested by the applicant.

Section 17 Modification of Licences

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Section 18 Enforcement Notices

(1) Subject to paragraphs (2) and (5), Schedule 9 shall have effect for the purposes of providing for the enforcement of these Regulations and for matters incidental thereto.

(2) Except in the case of apparatus which, in the opinion of an enforcement authority, is liable to endanger the safety of persons and, where appropriate, of property, where an enforcement authority has reasonable grounds for suspecting that the CE marking has been affixed to apparatus in relation to which any provision of these Regulations has not been complied with, it may serve notice in writing on—

(a) the manufacturer of the apparatus or his authorised representative established within the European Union ; or

(b) in a case where neither the manufacturer of the apparatus nor his authorised representative established within the European Union has placed the apparatus on the market, the person who places it on the market in the United Kingdom;

and subject to paragraph (3), no other action pursuant to Schedule 9 may be taken in respect of apparatus until such notice has been given and the person to whom it is given has failed to comply with its requirements.

(3) Notwithstanding the provisions of paragraph (2), for the purpose of ascertaining whether or not the CE marking has been correctly affixed, action may be taken pursuant to paragraph 8 of Schedule 9 .

(4) A notice which is given under paragraph (2) shall—

(a) state that the enforcement authority suspects that the CE marking has not been correctly affixed to the apparatus;

(b) specify the respect in which it is so suspected and give particulars thereof;

(c) require the person to whom the notice is given—

(i) to secure that any apparatus to which the notice relates conforms as regards the provisions concerning the correct affixation of the CE marking within such period as may be specified in the notice; or

(ii) to provide evidence within that period, to the satisfaction of the enforcement authority, that the CE marking has been correctly affixed; and

(d) warn that person that if the non-conformity continues after, or if satisfactory evidence has not been provided within, the period specified in the notice, further action may be taken under the Regulations in respect of that apparatus or apparatus of the same type placed on the market by that person.

(5) sections 94–97 and section 98(1)–(3) of the Communications Act 2003 shall apply for the purposes of the enforcement of regulations 7 and 13 above as if the requirements in those regulations were conditions set under section 45 of that Act.

Section 18A Duty of enforcement authority to inform Secretary of State of action taken

An enforcement authority shall, where action has been taken by it to prohibit or restrict the supply or taking into service (whether under these Regulations or otherwise) of any relevant apparatus, forthwith inform the Secretary of State of the action taken, and the reasons for it, with a view to this information being passed by her to the Commission.

Section 19 Offences

(1) Any person who—

(a) (subject to paragraph (2)) contravenes or fails to comply with regulation 5(1) or 12; or

(b) fails to supply or retain a copy of the appropriate documentation as required by regulation 9(3),

shall be guilty of an offence.

(2) No offence shall be committed merely by reason of failure to comply with regulation 12 in respect of equipment which uses frequency bands the use of which by that equipment is consistent with the United Kingdom Plan for Frequency Authorisation published under section 153 of the Communications Act 2003.

Section 20 Penalties

(1) A person guilty of an offence under regulation 19(a) shall be liable on summary conviction—

(a) to imprisonment for a term not exceeding 3 months; or

(b) to a fine not exceeding level 5 on the standard scale,

or to both.

(2) A person guilty of an offence under regulation 19(b) shall be liable on summary conviction to a fine not exceeding level 5 on the standard scale.

Section 21 Defence of due diligence

(1) Subject to the following provisions of this regulation, in proceedings against any person for an offence under regulation 19 or paragraph 11(1) of Schedule 9 above it shall be a defence for that person to show that he took all reasonable steps and exercised all due diligence to avoid committing the offence.

(2) Where in any proceedings against any person for such an offence the defence provided in paragraph (1) involves an allegation that the commission of the offence was due—

(a) to the act or default of another; or

(b) to reliance on information given by another,

that person shall not, without the leave of the court, be entitled to rely on the defence unless, not less than seven clear days before the hearing of the proceedings (or, in Scotland, the trial diet), he has served a notice under paragraph (3) on the person bringing the proceedings.

(3) A notice under this paragraph shall give such information identifying or assisting in the identification of the person who committed the act or default or gave the information as is in the possession of the person serving the notice at the time he serves it.

(4) It is hereby declared that a person shall not be entitled to rely on the defence provided in paragraph (1) by reason of his reliance on information supplied by another, unless he shows that it was reasonable in all the circumstances for him to have relied on the information, having regard in particular—

(a) to the steps which he took, and those which might reasonably have been taken, for the purpose of verifying the information; and

(b) to whether he had any reason to disbelieve the information.

Section 22 Liability of persons other than the principal offender

(1) Where the commission by any person of an offence under regulation 19 or paragraph 11(1) of Schedule 9 is due to the act or default committed by some other person in the course of any business of his, the other person shall be guilty of the offence and may be proceeded against and punished by virtue of this paragraph whether or not proceedings are taken against the first-mentioned person.

(2) Where a body corporate is guilty of an offence under these Regulations (including where it is so guilty by virtue of paragraph (1)) in respect of any act or default which is shown to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, any director, manager, secretary or other similar officer of the body corporate or any person who was purporting to act in any such capacity he, as well as the body corporate, shall be guilty of that offence and shall be liable to be proceeded against and punished accordingly.

(3) Where the affairs of a body corporate are managed by its members, paragraph (2) shall apply in relation to the acts and defaults of a member in connection with his functions of management as if he were a director of the body corporate.

(4) In this regulation, references to a “body corporate” include references to a partnership in Scotland and, in relation to such partnership, any reference to a director, manager, secretary or other similar officer of a body corporate is a reference to a partner.

Section 23 Savings for action taken under other enactments

Nothing in these Regulations shall be construed as preventing the taking of any action in respect of any relevant apparatus under the provisions of any other enactment.

Section 1

Radio equipment used by radio amateurs within Article 1, definition 53, of the International Telecommunications Union (ITU) radio regulations unless that equipment is available commercially.

Kits of components to be assembled by radio amateurs and commercial equipment modified by and for the use of radio amateurs are not regarded as commercially available equipment.

Section 2

Equipment falling within the scope of Council Directive 96/98EC of 20 December 1996 on marine equipment.

Section 3

Cabling and wiring.

Section 4

Receive only radio equipment intended to be used solely for the reception of sound and TV broadcasting services.

Section 5

Products, appliances and components within the meaning of Article 2 of Council Regulation (EEC) No. 3922/91 of 16 December 1991 on the harmonisation of technical requirements and administrative procedure in the field of civil aviation.

Section 6

Air-traffic management equipment and systems within the meaning of Article 1 of Council Directive 93/65EEC of 19 July 1993 on the definition and use of compatible technical specifications for the procurement of air-traffic management equipment and systems.

Section 1 Module A (internal production control)

This module describes the procedure whereby the manufacturer or his authorised representative established within the European Union , who carries out the obligations laid down in point 2, ensures and declares that the products concerned satisfy the requirements of this Directive that apply to them. The manufacturer or his authorised representative established within the European Union must affix the CE marking to each product and draw up a written declaration of conformity.

Section 2 Module A (internal production control)

The manufacturer must establish the technical documentation described in point 4 and he or his authorised representative established within the European Union must keep it for a period ending at least 10 years after the last product has been manufactured at the disposal of the relevant national authorities of any Member State for inspection purposes.

Section 3 Module A (internal production control)

Where neither the manufacturer nor his authorised representative is established within the European Union , the obligation to keep the technical documentation available is the responsibility of the person who places the product on the Community market.

Section 4 Module A (internal production control)

The technical documentation must enable the conformity of the product with the essential requirements to be assessed. It must cover the design, manufacture and operation of the product, in particular:

a general description of the product;

conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;

descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product;

a list of the standards referred to in Article 5, applied in full or in part, and descriptions and explanations of the solutions adopted to meet the essential requirements of the Directive where such standards referred to in Article 5 have not been applied or do not exist;

results of design calculations made, examinations carried out, etc.;

test reports.

Section 5 Module A (internal production control)

The manufacturer or his authorised representative must keep a copy of the declaration of conformity with the technical documentation.

Section 6 Module A (internal production control)

The manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the manufactured products with the technical documentation referred to in point 2 and with the requirements of this Directive that apply to them.

Section 1 Full quality assurance

Full quality assurance is the procedure whereby the manufacturer who satisfies the obligations of point 2 ensures and declares that the products concerned satisfy the requirements of the Directive that apply to them. The manufacturer must affix the marks referred to in Article 12(1) to each product and draw up a written declaration of conformity.

Section 2 Full quality assurance

The manufacturer must operate an approved quality system for design, manufacture and final product inspection and testing as specified in point 3 and must be subject to surveillance as specified in point 4.

Section 3 Full quality assurance

Quality system.

Section 3.1 Full quality assurance

The manufacturer must lodge an application for assessment of his quality system with a notified body. The application must include:

all relevant information for the products envisaged,

the quality system’s documentation.

Section 3.2 Full quality assurance

The quality system must ensure compliance of the products with the requirements of the Directive that apply to them. All the elements, requirements and provisions adoped by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.

It must contain in particular an adequate description of :

the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality,

the technical specifications, including the harmonised standards and technical regulations as well as relevant test specifications that will be applied and, where the standards referred to in Article 5(1) will not be applied in full, the means that will be used to ensure that the essential requirements of the Directive that apply to the products will be met,

the design control and design verification techniques, processes and systematic actions that will be used when designing the products pertaining to the product category covered,

the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,

the examinations and test that will be carried out before, during and after manufacture, and the frequency with which they will be carried out, as well as the results of the tests carried out before manufacture where appropriate,

the means by which it is ensured that the test and examination facilities respect the appropriate requirements for the performance of the necessary test,

the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,

the means to monitor the achievement of the required design and product quality and the effective operation of the quality system.

Section 3.3 Full quality assurance

The notified body must assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It must presume compliance with these requirements in respect of quality systems that implement the relevant harmonised standard.

The notified body must assess in particular whether the quality control system ensures conformity of the products with the requirements of the Directive in the light of the relevant documentation supplied in respect of points 3.1 and 3.2 including, where relevant, test results supplied by the manufacturer.

The auditing team must have at least one member experienced as an assessor in the product technology concerned. The evaluation procedure must include an assessment visit to the manufacturer’s premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

Section 3.4 Full quality assurance

The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to uphold it so that it remains adequate and efficient.

The manufacturer or his authorised representative must keep the notified body that has approved the quality system informed of any intended updating of the quality system.

The notified body must evaluate the modifications proposed and decide whether the amended quality system will still satisfy the requirements referred to in point 3.2 or whether a reassessment is required.

It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

Section 4 Full quality assurance

EC surveillance under the responsibility of the notified body.

Section 4.1 Full quality assurance

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

Section 4.2 Full quality assurance

The manufacturer must allow the notified body access for inspection purposes to the locations of design, manufacture, inspection and testing, and storage and must provide it with all necessary information, in particular:

the quality system documentation,

the quality records as foreseen by the design part of the quality system, such as results of analyses, calculations, tests, etc.,

the quality records as foreseen by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

Section 4.3 Full quality assurance

The notified body must carry out audits at reasonable intervals to make sure that the manufacturer maintains and applies the quality system and must provide an audit report to the manufacturer.

Section 4.4 Full quality assurance

Additionally, the notified body may pay unexpected visits to the manufacturer. At the time of such visits, the notified body may carry out tests or have them carried out in order to check the proper functioning of the quality system where necessary; it must provide the manufacturer with a visit report and, if a test has been carried out, with a test report.

Section 5 Full quality assurance

The manufacturer must, for a period ending at least 10 years after the last product has been manufactured, keep at the disposal of the national authorities:

the documentation referred to in the second indent of point 3.1,

the updating referred to in the second paragraph of point 3.4,

the decisions and reports from the notified body which are referred to in the final paragraph of point 3.4 and in points 4.3 and 4.4.

Section 6 Full quality assurance

Each notified body must make available to the other notified bodies the relevant information concerning quality system approvals including reference to the product(s) concerned, issued and withdrawn.