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The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016

Type Statutory-Instrument

Publication 2016-11-15

Last updated 2025-02-27

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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Reform history JSON API

[^key-9bc5139a34c7702159503dba32892170]: Sch. 2 para. 1 substituted (coming into force in accordance with reg. 1(2) of the amending S.I.) by The Treatment of Conformity Assessment Bodies (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Regulations 2024 (S.I. 2024/504), reg. 11

[^key-8f76f48fff9c51e6eadd61a845504310]: Words in reg. 2(1) omitted (1.10.2024) by virtue of The Product Safety and Metrology etc. (Amendment) Regulations 2024 (S.I. 2024/696), regs. 1(2), 16(2) (with reg. 23)

[^key-9ff9d7ea8041df16c6a114c6b95d2aaf]: Words in reg. 36A substituted (1.10.2024) by The Product Safety and Metrology etc. (Amendment) Regulations 2024 (S.I. 2024/696), regs. 1(2), 16(3)(a) (with reg. 23)

[^key-ef9478830564f05fda6fd818200cb37a]: Words in reg. 36A(2) omitted (1.10.2024) by virtue of The Product Safety and Metrology etc. (Amendment) Regulations 2024 (S.I. 2024/696), regs. 1(2), 16(3)(b) (with reg. 23)

[^key-d59c3ebb59fc87912e2b7397d8f32c1b]: Words in reg. 36A(4) omitted (1.10.2024) by virtue of The Product Safety and Metrology etc. (Amendment) Regulations 2024 (S.I. 2024/696), regs. 1(2), 16(3)(b) (with reg. 23)

[^key-e189a36756b33008a5c97c6745791750]: Reg. 36A(6) omitted (1.10.2024) by virtue of The Product Safety and Metrology etc. (Amendment) Regulations 2024 (S.I. 2024/696), regs. 1(2), 16(3)(c) (with reg. 23)

[^key-775084476b60315b13839ab848674296]: Reg. 36A(7) omitted (1.10.2024) by virtue of The Product Safety and Metrology etc. (Amendment) Regulations 2024 (S.I. 2024/696), regs. 1(2), 16(3)(c) (with reg. 23)

[^key-e89b365cebfd3ca340e4707e92ffc93a]: Reg. 36C substituted (1.10.2024) by The Product Safety and Metrology etc. (Amendment) Regulations 2024 (S.I. 2024/696), regs. 1(2), 16(4) (with reg. 23)

[^key-115ad6b668b2800a8a27f1c2e87e42bf]: Reg. 72A(4)-(6) omitted (1.10.2024) by virtue of The Product Safety and Metrology etc. (Amendment) Regulations 2024 (S.I. 2024/696), regs. 1(2), 16(5) (with reg. 23)

[^key-df3d8add0f4680b6c8221fe25c2fec27]: Word in reg. 2(1A) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 6 para. 10

[^key-3880ad6a84a9129aa74a85a85ecaebeb]: Word in reg. 2(1C) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 6 para. 10

Designated standard

2A

(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, service or system, including—

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

(ii) the requirements applicable to the product, service or system 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, service or system.

(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);

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

(9) Regulations made under paragraph (8) are to be made by statutory instrument.

(10) A statutory instrument containing regulations made under paragraph (8) is subject to annulment in pursuance of a resolution of either House of Parliament.

Scope

Exceptions for trade fairs, exhibitions and demonstrations

Declaration of conformity and UK marking

Provision of instructions and safety information

Provision of Instructions and safety information

Prohibition on improper use of UK marking

Obligations which are met by complying with obligations in the ATEX Directive

36A

(1) In this regulation—

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

(b) “CE marking” has the meaning given to it in Article 2(26); and

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

(a) ensures that the product has been designed and manufactured in accordance with the essential health and safety requirements set out in Annex II;

(b) ensures that the relevant conformity assessment procedures that apply to that product in accordance with Article 13(1) and (2) have been carried out;

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

(e) affixes a CE marking and the inscriptions in accordance with Articles 15 and 16(1) to (4);

(f) draws up an EU declaration of conformity, in accordance with Article 14; and

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

(3) Where this paragraph applies—

(a) the requirements of regulations 5, 6, 7(1), (3) and 7(6) are to be treated as being satisfied;

(b) regulations 2(a), 7(6), 8, 9(2), 17(4), 36 and 59 apply subject to the modifications in paragraph (10);

(d) regulation 57 does not apply.

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

(a) the relevant conformity assessment procedure referred to in Article 13 has been carried out;

(b) the manufacturer has drawn up the technical documents relevant to the conformity assessment procedure followed; and

(5) Where this paragraph applies—

(a) the requirements of regulation 19(1)(a) to (c) are to be treated as being satisfied; and

(b) regulations 2(a),18, 23 and 27 apply subject to the modifications in paragraph (10).

(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(8) Paragraph (9) applies where, before making a product available on the market, a distributor ensures that the product bears the CE marking and inscriptions referred to in point 1.0.5 of Annex II.

(9) Where this paragraph applies—

(a) regulation 29(1)(a)(i) is to be treated as being satisfied; and

(b) regulations 2(a), 30 and 31(1) apply subject to the modifications in paragraph (10).

(10) The modifications referred to in subparagraphs (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 reference to the CE marking;

(c) any reference to “essential health and safety requirements” is to be read as a reference to the essential health and safety requirements referred to in Annex II;

(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 13;

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

Conformity assessment procedure obligation which is met by complying with the ATEX Directive

36B

(1) In this regulation any reference to an Article or Annex is a reference to an Article or an Annex of the ATEX Directive;

(2) Paragraph (3) applies where, prior to the manufacture of a product, the manufacturer ensures that the conformity assessment procedure that applies to that product in accordance with Annex III as referred to in Article 13(1)(a) and (b) has been carried out.

(3) Where this paragraph applies—

(a) any requirement to follow the Type-examination set out in Part 1 of Schedule 3A in regulation 39 is to be treated as being satisfied;

(b) any reference to “relevant conformity assessment procedure” in regulations 6(a), 7(1), 19(a), 36(1)(b), 40(c) and 41(3) is to be read as including the conformity assessment procedure set out in Annex III as referred to in Article 13(1)(a) and (b); and

(c) any reference to “technical documentation” in regulations 6(b), 8, 19(b) and 27(b) is to be read as including the technical documentation relating to the design of the product referred to in Annex III.

Expiry of regulations 36A and 36B

36C

(1) In this regulation—

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

(b) “harmonised standard” has the meaning given to it in Article 2(18).

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

(a) ensures that the product has been designed and manufactured in accordance with the essential health and safety requirements set out in Annex II;

(b) ensures that the relevant conformity assessment procedures that apply to the product in accordance with Article 13(1) and (2) have been carried out;

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

(3) Where this paragraph applies—

(a) regulations 5 and 6 are to be treated as being satisfied;

(b) except for regulations 40 and 41(1) to (2) and (5) to (6), Part 3 does not apply;

(c) regulations 2(2)(a), 7 to 9, 18, 19(1)(a) and (b), 20, 23, 27, 30, 31, 36 and 59 apply subject to the modifications in paragraph (4);

(d) regulations 40 and 41(6) and Schedule 6 apply subject to the modifications in paragraphs (4) and (5).

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

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

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

(c) any reference to “relevant conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedure that applies to that product in accordance with Article 13;

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

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

(a) in regulation 40, the reference to “Schedule 3A to these Regulations” is to be read as a reference to Annexes III to IX;

(b) regulation 41(5) is to be read as if the words beginning with “and, where” and ending with “body” were omitted;

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

(ii) in paragraph 7 the reference to “approved body” is to be read as a reference to the conformity assessment body that undertook the relevant conformity assessment procedure in accordance with Article 13.

Qualifying Northern Ireland Goods

36D

(1) In this regulation—

“the 2017 Regulations” means the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations (Northern Ireland) 2017;

“CE marking” has the meaning given to it in regulation 2(1) of the 2017 Regulations;

“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) of the 2017 Regulations;

“technical documentation” has the meaning given to it in regulation 2(1) of the 2017 Regulations.

(2) Where paragraph (3) applies, a product is to be treated as being in conformity with Part 2.

(3) This paragraph applies where—

(a) a product—

(i) is in conformity with Part 2, within the meaning of regulation 2(2) of the 2017 Regulations; and

(ii) is qualifying Northern Ireland goods; and

(b) an importer has complied with the obligations set out in paragraph (4).

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

(a) complies with regulation 21;

(b) ensures that—

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

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

(iii) the product bears the CE marking.

Translation of declaration of conformity

... Declaration of conformity

UK Marking

Approved bodies

Approval of conformity assessment bodies

Presumption of conformity of approved bodies

Monitoring

Restriction, suspension or withdrawal of approval

Operational matters in relation to approved bodies

Subsidiaries and contractors

Register of approved bodies

UK national accreditation body

Transitional provision in relation to EU Exit

72A

(1) In this regulation—

(2) Subject to paragraph (3), where a product was made available on the market during the pre-exit period, despite the amendments made by Schedule 25 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, any obligation to which a person was subject under these Regulations as they had effect immediately before IP completion day, continues to have effect as it did immediately before IP completion day, in relation to that product.

(3) Paragraph (2) does not apply to—

(a) any obligation of any enforcing authority to inform the European Commission or the member States of any matter; or

(b) any obligation to take action outside of the market in respect of that product.

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Revocations and savings

Consequential Amendments

SCHEDULE 1A — Criteria determining the classification of equipment-groups into categories (Annex I to the ATEX Directive)

1

Equipment group I

(a) Equipment category M 1 comprises equipment designed and, where necessary, equipped with additional special means of protection to be capable of functioning in conformity with the operational parameters established by the manufacturer and ensuring a very high level of protection.

Equipment in this category is intended for use in underground parts of mines as well as those parts of surface installations of such mines endangered by firedamp and/or combustible dust.

Equipment in this category is required to remain functional, even in the event of rare incidents relating to equipment, with an explosive atmosphere present, and is characterised by means of protection such that:

— either, in the event of failure of one means of protection, at least an independent second means provides the requisite level of protection,

— or the requisite level of protection is assured in the event of two faults occurring independently of each other.

Equipment in this category must comply with the supplementary requirements referred to in paragraph 30 of Schedule 1.

(b) Equipment category M 2 comprises equipment designed to be capable of functioning in conformity with the operational parameters established by the manufacturer and ensuring a high level of protection.

Equipment in this category is intended for use in underground parts of mines as well as those parts of surface installations of such mines likely to be endangered by firedamp and/or combustible dust.

This equipment is intended to be de-energised in the event of an explosive atmosphere.

The means of protection relating to equipment in this category assure the requisite level of protection during normal operation and also in the case of more severe operating conditions, in particular those arising from rough handling and changing environmental conditions.

Equipment in this category must comply with the supplementary requirements referred to in paragraph 31 of Schedule 1.

2

Equipment-group II

(a) Equipment category 1 comprises equipment designed to be capable of functioning in conformity with the operational parameters established by the manufacturer and ensuring a very high level of protection.

Equipment in this category is intended for use in areas in which explosive atmospheres caused by mixtures of air and gases, vapours or mists or by air/dust mixtures are present continuously, for long periods or frequently.

Equipment in this category must ensure the requisite level of protection, even in the event of rare incidents relating to equipment, and is characterised by means of protection such that:

— either, in the event of failure of one means of protection, at least an independent second means provides the requisite level of protection,

— or the requisite level of protection is assured in the event of two faults occurring independently of each other.

Equipment in this category must comply with the supplementary requirements referred to in paragraphs 32 and 33 of Schedule 1.

(b) Equipment category 2 comprises equipment designed to be capable of functioning in conformity with the operational parameters established by the manufacturer and of ensuring a high level of protection.

Equipment in this category is intended for use in areas in which explosive atmospheres caused by gases, vapours, mists or air/dust mixtures are likely to occur occasionally.

The means of protection relating to equipment in this category ensure the requisite level of protection, even in the event of frequently occurring disturbances or equipment faults which normally have to be taken into account.

Equipment in this category must comply with the supplementary requirements referred to in paragraphs 34 and 35 of Schedule 1.

(c) Equipment category 3 comprises equipment designed to be capable of functioning in conformity with the operating parameters established by the manufacturer and ensuring a normal level of protection.

Equipment in this category is intended for use in areas in which explosive atmospheres caused by gases, vapours, mists, or air/dust mixtures are unlikely to occur or, if they do occur, are likely to do so only infrequently and for a short period only.

Equipment in this category ensures the requisite level of protection during normal operation.

Equipment in this category must comply with the supplementary requirements referred to in paragraphs 36 and 37 of Schedule 1.

SCHEDULE 3A — Conformity Assessment Procedures (Annexes III to IX of the ATEX Directive)

PART 1

TYPE EXAMINATION

1

Type examination is the part of a conformity assessment procedure in which an approved body examines the technical design of a product and verifies and attests that the technical design of the product meets the requirements of these Regulations that apply to it.

2

Type examination shall be carried out with the examination of a specimen, representative of the production envisaged, of the complete product (production type).

3

The manufacturer shall lodge an application for Type examination with a single approved body of his choice.

4

The approved body shall:

4

examine the technical documentation, verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant designated standards, as well as the elements which have been designed in accordance with other relevant technical specifications;

4

carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant designated standards, these have been applied correctly;

4

carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant designated standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential health and safety requirements of these Regulations;

4

agree with the manufacturer on a location where the examinations and tests will be carried out.

5

The approved body shall draw up an evaluation report that records the activities undertaken in accordance with paragraph 4 and their outcomes. Without prejudice to its obligations vis-à-vis the Secretary of State, the approved body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

6

Where the type meets the requirements of these Regulations that apply to the product concerned, the approved body shall issue a Type examination certificate to the manufacturer. That certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The Type examination certificate may have one or more annexes attached.

7

The approved body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of these Regulations and shall determine whether such changes require further investigation. If so, the approved body shall inform the manufacturer accordingly.

8

Each approved body shall inform the Secretary of State concerning the Type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.

9

The manufacturer shall keep a copy of the Type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market.

10

The manufacturer's authorised representative may lodge the application referred to in paragraph 3 and fulfil the obligations set out in paragraphs 7 and 9, provided that they are specified in the mandate.

PART 2 — CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS

1

Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 5, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the Type examination certificate and satisfy the requirements of these Regulations that apply to them.

Manufacturing

2

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the products concerned as specified in paragraph 3 and shall be subject to surveillance as specified in paragraph 4.

Quality system

3

The manufacturer shall lodge an application for assessment of his quality system with the approved body of his choice, for the products concerned.

3

The quality system shall ensure that the products are in conformity with the type described in the Type examination certificate and comply with the requirements of these Regulations that apply to them.

3

The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2.

3

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

3

The manufacturer shall keep the approved body that has approved the quality system informed of any intended change to the quality system.

Surveillance under the responsibility of the approved body

4

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

4

The manufacturer shall, for assessment purposes, allow the approved body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

(a) the quality system documentation,

(b) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

4

The approved body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

4

In addition, the approved body may pay unexpected visits to the manufacturer. During such visits the approved body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The approved body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

UK marking, declaration of conformity and attestation of conformity

5

The manufacturer shall affix the UK marking and, under the responsibility of the approved body referred to in paragraph 3.1, the latter's identification number to each individual product other than a component that is in conformity with the type described in the Type examination certificate and satisfies the applicable requirements of these Regulations.

5

The manufacturer shall draw up a written declaration of conformity for each product model, other than a component and keep it at the disposal of the national authorities for 10 years after the product other than a component has been placed on the market. The declaration of conformity shall identify such product model for which it has been drawn up.

5

The manufacturer shall draw up a written attestation of conformity for each component model and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component model for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

6

The manufacturer shall, for a period ending 10 years after the product has been placed on the market, keep at the disposal of the national authorities:

(a) the documentation referred to in paragraph 3.1,

(b) the information relating to the change referred to in paragraph 3.5, as approved,

7

Each approved body shall inform the Secretary of State of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted.

Authorised representative

8

The manufacturer's obligations set out in paragraphs 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

PART 3 — CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION

1

Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 5 and ensures and declares on his sole responsibility that the products concerned, which have been subject to the provisions of paragraph 3, are in conformity with the type described in the Type examination certificate and satisfy the requirements of these Regulations that apply to them.

Manufacturing

2

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the Type examination certificate and with the requirements of these Regulations that apply to them.

Verification

3

An approved body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the products with the approved type described in the Type examination certificate and with the appropriate requirements of these Regulations.

Verification of conformity by examination and testing of every product

4

All products shall be individually examined, and appropriate tests set out in the relevant designated standard(s) and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify conformity with the approved type described in the Type examination certificate and with the appropriate requirements of these Regulations.

4

The approved body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to each approved product or have it affixed under its responsibility.

UK marking, declaration of conformity and attestation of conformity

5

The manufacturer shall affix the UK marking and, under the responsibility of the approved body referred to in paragraph 3, the latter's identification number to each individual product other than a component that is in conformity with the approved type described in the Type examination certificate and satisfies the applicable requirements of these Regulations.

5

The manufacturer shall draw up a written declaration of conformity for each product model other than a component and keep it at the disposal of the national authorities, for 10 years after the product, other than a component, has been placed on the market. The declaration of conformity shall identify such product model for which it has been drawn up.

5

6

If the approved body agrees and under its responsibility, the manufacturer may affix the approved body's identification number to the products during the manufacturing process.

Authorised representative

7

The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer's obligations set out in paragraph 2.

PART 4 — CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT TESTING

1

Conformity to type based on internal production control plus supervised product testing is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3 and 4, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the Type examination certificate and satisfy the requirements of these Regulations that apply to them.

Manufacturing

2

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the type described in the Type examination certificate and with the requirements of these Regulations that apply to them.

Product checks

3

For each individual product manufactured one or more tests on one or more specific aspects of the product shall be carried out by the manufacturer or on his behalf, in order to verify conformity with the type described in the Type examination certificate and with the corresponding requirements of these Regulations. The tests shall be carried out under the responsibility of an approved body, chosen by the manufacturer.

UK marking, declaration of conformity and attestation of conformity

4

The manufacturer shall affix the UK marking to each individual product other than a component that is in conformity with the type described in the Type examination certificate and satisfies the applicable requirements of these Regulations.

4

The manufacturer shall draw up a written declaration of conformity for a product model other than a component and keep it at the disposal of the national authorities for 10 years after the product, other than a component has been placed on the market. The declaration of conformity shall identify such product model for which it has been drawn up.

4

Authorised representative

5

The manufacturer's obligations set out in paragraph 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

PART 5 — CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE

1

Conformity to type based on product quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 5 and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the Type examination certificate and satisfy the requirements of these Regulations that apply to them.

Manufacturing

2

The manufacturer shall operate an approved quality system for final product inspection and testing of the products concerned as specified in paragraph 3 and shall be subject to surveillance as specified in paragraph 4.

Quality System

3

The manufacturer shall lodge an application for assessment of his quality system with the approved body of his choice, for the products concerned.

3

The quality system shall ensure compliance of the products with the type described in the Type examination certificate and with the applicable requirements of these Regulations.

3

The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2.

3

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

3

The manufacturer shall keep the approved body that has approved the quality system informed of any intended change to the quality system.

Surveillance under the responsibility of the approved body

4

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

4

(a) the quality system documentation,

(b) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

4

The approved body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

4

UK marking, declaration of conformity and attestation of conformity

5

6

The manufacturer shall, for a period ending 10 years after the product has been placed on the market, keep at the disposal of the national authorities:

(a) the documentation referred to in paragraph 3.1,

(b) the information relating to the change referred to in paragraph 3.5, as approved,

7

Authorised representative

8

PART 6 — INTERNAL PRODUCTION CONTROL

1

Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3 and 4, and ensures and declares on his sole responsibility that the products concerned satisfy the requirements of these Regulations that apply to them.

Technical documentation

2

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the product's conformity to the relevant requirements and shall include an adequate analysis and assessment of the risk(s).

Manufacturing

3

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured products with the technical documentation referred to in paragraph 2 and with the requirements of these Regulations that apply to them.

UK marking, declaration of conformity and attestation of conformity

4

The manufacturer shall affix the UK marking to each individual product other than a component that satisfies the applicable requirements of these Regulations.

4

The manufacturer shall draw up a written declaration of conformity for a product model other than a component and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product, other than a component, has been placed on the market. The declaration of conformity shall identify such product model for which it has been drawn up.

4

The manufacturer shall draw up a written attestation of conformity for each component model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

Authorised representative

5

The manufacturer's obligations set out in paragraph 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

PART 7 — CONFORMITY BASED ON UNIT VERIFICATION

1

Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3 and 5, and ensures and declares on his sole responsibility that the product concerned, which has been subject to the provisions of paragraph 4, is in conformity with the requirements of these Regulations that apply to it.

Technical documentation

2

The manufacturer shall establish the technical documentation and make it available to the approved body referred to in paragraph 4. The documentation shall make it possible to assess the product's conformity with the relevant requirements and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain at least the following elements:

(a) a general description of the product,

(b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

(c) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,

(d) a list of the designated standards applied in full or in part and, where those designated standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of these Regulations, including a list of other relevant technical specifications applied. In the event of partly applied designated standards, the technical documentation shall specify the parts which have been applied,

(e) results of design calculations made, examinations carried out, etc., and

(f) test reports.

2

The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the product has been placed on the market.

Manufacturing

3

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with the applicable requirements of these Regulations.

Verification

4

An approved body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant designated standards and/or equivalent tests set out in other relevant technical specifications, to check the conformity of the product with the applicable requirements of these Regulations, or have them carried out. In the absence of such a designated standard the approved body concerned shall decide on the appropriate tests to be carried out.

UK marking, declaration of conformity and attestation of conformity

5

The manufacturer shall affix the UK marking and, under the responsibility of the approved body referred to in paragraph 4, the latter's identification number to each product other than a component that satisfies the applicable requirements of these Regulations.

5

The manufacturer shall draw up a written declaration of conformity and keep it at the disposal of the national authorities for 10 years after the product, other than a component has been placed on the market. The declaration of conformity shall identify such product for which it has been drawn up.

5

The manufacturer shall draw up a written attestation of conformity and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

Authorised representative

6

The manufacturer's obligations set out in paragraphs 2.2 and 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

Further Use of UK marking

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