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S.I. No. 230/2017 - European Union (Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres) Regulations 2017

Type Statutory Instrument

Publication 2017-06-02

Last updated 2022-07-05

State In force superseded text

Text As published

Source Irish Statute Book

articles 52

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

1 amending act · 2022-07-05, S.I. No. 322/2022 - European Union (Equipment and Protective Systems Intended for Use in …

Reform history JSON API

(10) A statement or admission made by a person pursuant to a requirement under paragraph (1)(i), (k) or (l) shall not be admissible in proceedings brought against that person for an offence (other than an offence under Regulation 42(4)) relating to a breach of, or failure to comply with, an obligation in the said paragraph (1)(i), (k) or (l).

Measures entailing refusal or restriction

33.

An inspector who finds that—

(a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No. 765/2008, Article 16 of the Directive or of Regulation 17 of these Regulations,

(b) the CE marking, where required, has not been affixed,

(c) the specific marking of explosion protection [image omitted], the symbols of the equipment-group and category and, where applicable, the other markings and information have been affixed in violation of point 1.0.5 of Annex II to the Directive, the text of which is set out in Schedule 2 to these Regulations, or have not been affixed,

(d) the identification number of the notified body, where that body is involved in the production control phase, has been affixed in violation of Article 16 of the Directive and Regulation 17 or has not been affixed,

(e) the EU declaration of conformity or the attestation of conformity, as appropriate, does not accompany the product,

(f) the EU declaration of conformity or, where required, the attestation of conformity has not been drawn up correctly,

(g) technical documentation is either not available or not complete,

(h) the information referred to in Articles 6(7) or 8(3) of the Directive or Regulation 7(j) or 9(2)(c) is absent, false or incomplete, or

(i) any other administrative requirement provided for in Articles 6 or 8 of the Directive or Regulation 7 or 9 is not fulfilled,

may issue a direction in writing to the relevant economic operator to put an end to the non-compliance observed within a specified timeframe.

Contravention notice

34.

(1) An inspector who is of the opinion that a person—

(a) is contravening or has contravened any of the provisions of the Directive or these Regulations, or

(b) has failed to comply with a direction under Regulation 33,

may serve a notice on the person who has or may reasonably be presumed to have control of the activity concerned.

(2) A contravention notice shall—

(a) state that the inspector is of the opinion referred to in paragraph (1),

(b) specify the grounds for the inspector being of the opinion referred to in paragraph (1) and specify the Regulation or Regulations concerned,

(d) direct the person, where required, to—

(i) remedy the contravention or the matters occasioning that notice,

(ii) cease placing or making available the product on the market or putting it into use,

(iii) remove the product from the market,

(iv) recall the product,

(v) dispose of the product,

(vi) destroy the product where it presents a serious risk,

by a date specified in the notice that shall not be earlier than the end of the period within which an appeal may be made under Regulation 35(1),

(e) include information regarding the making of an appeal under Regulations 35(1) and 35(2),

(f) include any other requirement that the inspector considers appropriate,

(g) state that if the person to whom the notice is addressed fails to take such measures as are specified in the notice within the time period specified in that notice, that person commits an offence, and

(h) be signed and dated by the inspector.

(3) A contravention notice may include directions—

(a) as to the measures to be taken to remedy any contravention or matter to which the notice relates, or to otherwise comply with the notice, and

(b) to bring the notice to the attention of any person who may be affected by it, or to the public generally.

(4) A person on whom a contravention notice has been served who is of the opinion that the contravention notice has been complied with shall confirm in writing to the inspector that the matters referred to in the notice have been so remedied.

(5) Where a person on whom a contravention notice has been served confirms in writing to the inspector in accordance with paragraph (4) that the matters referred to in the contravention notice have been remedied, the inspector shall, on being satisfied that the matters have been so remedied, within one month of receipt of such confirmation, give notice to the person concerned of compliance with the contravention notice.

(6) An inspector may—

(a) withdraw or amend a contravention notice at any time, or

(b) where no appeal is made or pending under Regulation 35(1) extend the period specified under paragraph (2) (d) of this Regulation.

(7) Where there is no appeal under Regulation 35(1), the contravention notice shall take effect on the later of—

(a) the end of the period for making an appeal, or

(b) the day specified in the notice.

(8) A person shall comply with a contravention notice under this Regulation.

Appeal against contravention notice

35.

(1) A person aggrieved by a contravention notice may, within 14 days beginning on the day on which the notice is served on him or her, appeal against the notice to a judge of the District Court in the district court district in which the notice was served in and, in determining the appeal the judge may, if he or she is satisfied that it is reasonable to do so, confirm, vary or cancel the notice.

(2) A person who appeals under paragraph (1) shall at the same time notify the market surveillance authority of the appeal and the grounds for the appeal and the authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal.

(3) Where an appeal under paragraph (1) is taken, and the contravention notice is not cancelled, the notice shall take effect on the later of—

(a) the day next following the day on which the notice is confirmed on appeal or the appeal is withdrawn, or

(b) the day specified in the notice.

(4) Subject to paragraph (5), in the case of a product which the inspector does not consider to present a serious risk requiring rapid intervention as per Article 20 of EU Regulation 765/2008, the intended recipient of a measure referred to in Regulation 34(1) shall have the opportunity to make representations within 10 working days of first being advised of the inspector’s intention, to the market surveillance authority in advance of the measure being taken.

(5) Where, due to the urgency of the measure referred to in Regulation 34(1), as justified in particular by public health, security or safety requirements, it is not possible to give the person concerned the opportunity to make representations in advance of the measure being taken, the market surveillance authority shall give such opportunity, as soon as may be, thereafter.

Prohibition notice

36.

(1) A prohibition notice may be served by an inspector—

(a) on the person who is or who may reasonably be presumed to be in control of the activity concerned, where that inspector is of the opinion that at any place there is occurring or is likely to occur any activity relating to a product that gives rise to or is likely to give rise to a serious risk requiring rapid intervention, including a serious risk the effects of which are not immediate, or

(b) on any person in relation to a product in respect of which a direction under Regulation 33 or a contravention notice has been issued but not complied with.

(2) A prohibition notice shall—

(a) state that the inspector is of the opinion referred to in paragraph (1),

(b) state the reason for that opinion,

(d) where in the opinion of the inspector the activity involves a contravention, or likely contravention of any provision of the Directive or these Regulations, specify the provision,

(e) prohibit the carrying on of the activity concerned until the matters that give rise or are likely to give rise to the risk are remedied,

(f) inform the person concerned that he or she may appeal the prohibition notice to the District Court in accordance with Regulation 37(1),

(g) state that if the person to whom the prohibition notice is addressed fails to comply with the notice within the time period specified in the notice, that person commits an offence, and

(h) be signed and dated by the inspector.

(3) A prohibition notice may include directions—

(a) as to the measures to be taken to remedy any contravention or matter to which the notice relates, or to otherwise comply with the notice, and

(b) to bring the notice to the attention of any person who may be affected by it, or to the public generally.

(4) A prohibition notice shall take effect—

(a) when the notice is received by the person on whom it is served, or

(b) where an appeal is brought against the prohibition notice, on the day immediately following—

(i) the day on which the notice is confirmed on appeal or the appeal is withdrawn, or

(ii) the day specified in the notice,

whichever occurs later.

(5) A person on whom a prohibition notice has been served who is of the opinion that the matters referred to in the prohibition notice have been remedied by the date specified in the notice shall confirm in writing to the inspector that those matters have been so remedied.

(6) Where a person on whom a prohibition notice has been served confirms in writing to the inspector in accordance with paragraph (5) that the matters referred to in the prohibition notice have been remedied, the inspector shall, on being satisfied that the matters have been so remedied, within one month of receipt of such confirmation, give notice to the person concerned of such compliance with the prohibition notice.

(7) An inspector may at any time withdraw a prohibition notice if—

(a) the inspector is satisfied that the activity to which the notice relates no longer gives rise to a serious risk to safety or health, or

(b) the inspector is satisfied that the notice was issued in error or is incorrect in some material respect.

(8) A person shall comply with a prohibition notice under this Regulation.

Appeal against prohibition notice

37.

(1) A person on whom a prohibition notice is served may, within 7 days beginning on the day on which the notice is served on him or her, appeal against the notice to a judge of the District Court in the district court district in which the notice was served and in determining the appeal the judge may, if he or she is satisfied that it is reasonable to do so, confirm, vary or cancel the notice.

(2) Where, on the hearing of an appeal under this Regulation, a prohibition notice is confirmed, notwithstanding Regulation 36(4), the judge by whom the appeal is heard may, on the application of the appellant, suspend the operation of the prohibition notice for such period as in the circumstances of the case the judge considers appropriate.

(3) A person who—

(a) brings an appeal under paragraph (1), or

(b) applies for the suspension of the operation of a prohibition notice under this Regulation,

shall at the same time notify the market surveillance authority of the appeal or the application, and the grounds for the appeal or application.

(4) In the case of an appeal or any application to suspend the operation of the prohibition notice under this Regulation, the market surveillance authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal or application.

(5) The bringing of an appeal against a prohibition notice shall not have the effect of suspending the operation of the notice but the appellant may apply to the court to have the operation of the notice suspended until the appeal is disposed of and, on such application, the court may, if it thinks proper to do so, direct that the operation of the notice be suspended until the appeal is disposed of.

Order of the High Court

38.

(1) Where a person contravenes a prohibition notice an inspector may apply ex parte to the High Court for an order prohibiting the continued contravention of the notice.

(2) The High Court may, upon an application under this Regulation, order the person on whom the prohibition notice concerned was served to cease doing such acts as the High Court directs.

Information notice

39.

(1) An inspector or the market surveillance authority may, by notice served on a person, require the person to give, within such period and in such form as may be specified in the notice, any information specified in the notice that the inspector or the authority may reasonably require for the proper performance by it of his or her or its functions under the Directive or these Regulations.

(2) Upon the written application of the person on whom the notice is served, the period specified in the information notice may be extended by and at the discretion of—

(i) the market surveillance authority, or

(ii) an inspector.

(3) A person on whom an information notice is served may, within 7 days beginning on the day on which the notice is served on him or her, appeal against the notice to a judge of the District Court in the district court district in which the notice was served and in determining the appeal the judge may, if he or she is satisfied that it is reasonable to do so, confirm, vary or cancel the notice.

(4) A person who appeals under paragraph (3) shall at the same time notify the market surveillance authority of the appeal and the grounds for the appeal and the authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal.

(5) Where, on the hearing of an appeal under paragraph (3), an information notice is confirmed or varied, the judge of the District Court by whom the appeal is heard may, on the application of the appellant, suspend the operation of the notice for such period as in the circumstances of the case the judge considers appropriate.

(6) Subject to paragraph (7), a person on whom an information notice is served shall comply with the notice before the later of—

(a) the end of the period specified in the notice, or

(b) where the period referred to in subparagraph (a) is extended under paragraph (2), the end of that extended period.

(7) Where an appeal is brought under this Regulation, and the information notice to which the appeal relates is confirmed or varied or the appeal is withdrawn, the person on whom the notice is served shall comply with the notice before—

(a) the day immediately following the day on which the notice is confirmed or varied or the appeal is withdrawn,

(b) the end of the period specified in the notice, or

whichever occurs latest.

Service of notifications

40.

(1) Subject to paragraphs (2) and (3), a notice or other document required or authorised to be served on, sent or given to a person shall be addressed to the person concerned by name and may be given to the person in one of the following ways—

(a) by delivering it to the person,

(b) by leaving it at the address at which the person carries on business or ordinarily resides or, in the case in which an address for service has been furnished, at that address,

(c) by sending it by post in a prepaid registered letter to the address at which the person carries on business or ordinarily resides or, in a case in which an address for service has been furnished, to that address,

(d) if the person concerned has agreed to service of notices by means of an electronic communication (within the meaning assigned by section 2 of the Electronic Commerce Act 2000 ), service by such means, provided that there is a facility for confirming receipt of electronic communication and that such receipt has been confirmed,

(e) if the address at which the person ordinarily resides cannot be ascertained by reasonable enquiry and the compliance notice relates to a premises, by delivering it to the premises or by affixing it in a conspicuous position on or near the premises, or

(f) by any other means that may be prescribed.

(2) Where a notice or other document required or authorised to be served on, sent or given to a person is to be given to a person who is the owner or occupier of land or property and the name of the person cannot be ascertained by reasonable inquiry, it may be addressed to the person by using the words “the owner” or, as the case may require, “the occupier”.

(3) For the purposes of this Regulation, a company within the meaning of the Companies Acts shall be deemed to be ordinarily resident at its registered office, and every other body corporate and every unincorporated body shall be deemed to be ordinarily resident at its principal office or place of business.

Sharing information on the application of the Directive

41.

(1) The market surveillance authority may provide information to any European Union information network, the European Commission or a competent authority of another Member State for the purpose of sharing information related to the application of the Directive.

(2) The market surveillance authority may, in the interest of the protection of safety, take such measures as it considers appropriate to bring to the attention of the public, any matter of concern arising from the requirements of these Regulations.

PART 7 OFFENCES AND PENALTIES

Offences

42.

(1) A person who contravenes a provision or requirement of Regulation 5, 7, 8(3), 9, 10, 12, 27(2), 27(5) or 29(2) commits an offence.

(2) A person who contravenes a requirement of Regulation 32, 33, 34, 36 or 39, or a notice issued or measure taken thereunder commits an offence.

(3) A person who, in relation to the CE marking or any document required for the purposes of these Regulations—

(a) forges or counterfeits any such document,

(b) gives or signs a document or makes a marking knowing it to be false in any material particular,

(d) knowingly uses as applying to any person or product a marking or document which does not so apply,

(e) knowingly connives at any such forging, counterfeiting, giving, signing, or using,

(f) knowingly makes a false entry in any such document which is so required to be kept, served or sent,

(g) knowingly uses any such false entry, or

(h) knowingly has, without lawful authority, a forged marking or document or an altered marking or document in his or her possession,

commits an offence.

(4) Any person who obstructs or interferes with an inspector or a member of the Garda Síochána in the course of exercising a power conferred on him or her by these Regulations or a warrant under Regulation 32(7) or impedes the exercise by the inspector or member, as the case may be, of such power, or fails or refuses to comply with a request or requirement of, or to answer a question asked by, an inspector or such a member pursuant to a power conferred by these Regulations, or in purported compliance with such request or requirement, or who in answer to such question gives information to the inspector or member that he or she knows to be false or misleading in any material respect, commits an offence.

(5) A person who falsely represents himself or herself to be an inspector commits an offence.

(6) A person who, at any time during the period of 3 months immediately following the affixing of a notice in accordance with Regulation 40(1)(e), removes, alters, damages or defaces the notice without lawful authority commits an offence.

(7) A person who, prevents or attempts to prevent any person from answering any question to which an inspector may require an answer under Regulation 32, commits an offence.

(8) A person who, fails to comply with a bona fide request, instruction or directions from an inspector in the exercise of his or her functions under these Regulations, commits an offence.

(9) Where an offence under any of these Regulations is committed by reason of a failure to do something at or within a time fixed by or under any of those provisions, the offence shall be deemed to continue until that thing is done.

(10) A person who states to the market surveillance authority that another person has committed an offence under this Regulation or has failed to comply with a provision of these Regulations, knowing the statement to be false, commits an offence.

(11) A person who, in purported compliance with a requirement in an information notice, furnishes information to the market surveillance authority that he or she knows to be false or misleading in a material respect commits an offence.

Penalties

43.

(1) A person guilty of an offence under Regulation 42 shall be liable—

(a) on summary conviction, to a class A fine or imprisonment for a term not exceeding 6 months or both, or

(b) on conviction on indictment, to a fine not exceeding €500,000 or imprisonment for a term not exceeding 2 years or both.

(2) Where a person is convicted of an offence under these Regulations in proceedings brought by the market surveillance authority, or instituted following an investigation by the authority, the court shall, unless it is satisfied that there are special and substantial reasons for not so doing, order the person to pay to the authority the costs and expenses, measured by the court, incurred by the authority in relation to the investigation, detection and prosecution of the offence, including the costs and expenses incurred in the taking of samples, the carrying out of tests, examinations and analyses and in respect of the remuneration and other expenses of employees, consultants and advisers engaged by the authority.

Offences by bodies corporate

44.

Where an offence under these Regulations has been committed by a body corporate and is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, a person being a director, manager, secretary or other officer of the body corporate, or a person who was purporting to act in any such capacity, that person as well as the body corporate commits an offence and shall be liable to be proceeded against and punished as if he or she had committed the first-mentioned offence.

Prosecution of offences

45.

(1) Subject to paragraph (2), summary proceedings in relation to an offence under these Regulations may be brought and prosecuted by the market surveillance authority.

(2) Notwithstanding section 10(4) of the Petty Sessions (Ireland) Act 1851 , summary proceedings for an offence under Regulation 42 may be instituted at any time within 12 months from the date on which the offence was committed or alleged to have been committed.

PART 8 MISCELLANEOUS

Appeal to Circuit Court from certain orders of District Court

46.

For the avoidance of doubt, an order of the District Court confirming, varying or cancelling a notice under Regulation 34, 36 or 39 is a decision of a judge of the District Court for the purposes of section 84 of the Courts of Justice Acts 1924.

Notice or direction to be in writing

47.

Any notice or direction under these Regulations shall be in writing.

Immunity

48.

None of the following persons, that is to say, the market surveillance authority, an inspector, or a member or a member of staff of the market surveillance authority shall be liable in damages in respect of any act done or omitted to be done by it or him or her in the performance, or purported performance, of that person’s functions under these Regulations, unless the act or omission concerned was done in bad faith.

Indemnification

49.

The market surveillance authority shall, subject to the provisions of any enactment or rule of law, indemnify an inspector appointed by it, or a member or a member of staff of the market surveillance authority, in respect of any act done or omitted to be done by him or her in the performance, or purported performance, of his or her functions under these Regulations as such inspector, member or member of staff, unless the act or omission concerned was done in bad faith.

Restrictions on the disclosure of information

50.

A person in receipt of information as a result of the application of these Regulations shall treat same as confidential. In particular, business, professional and trade secrets shall be treated as confidential unless the divulging of such information is—

(a) for the purpose of the discharge of functions under these Regulations,

(b) made with the consent of the person to whom the information applies, or

(i) any legal proceedings (including by means of a report to a coroner holding an inquest under the Coroners Acts 1962 and 2005 on the body of a person whose death may have been caused through personal injury), or

(ii) any investigation or special report under section 70 of the Act of 2005,

(d) necessary in order to protect the health and safety of persons,

(e) required by the provisions of these Regulations or the Directive, or

(f) ordered by a court of law.

Transitional

51.

(1) The making available on the market of products or the putting into service of a product, in conformity with Directive 94/9/EC or the Regulations of 1999, and which was placed on the market or put into service before 20 April 2016 continues to be lawful.

(2) Certificates issued under Directive 94/9/EC or the Regulations of 1999 continue to be valid under these Regulations.

Revocation

52.

The European Communities (Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres) Regulations, ( S.I. No. 83 of 1999 ) are revoked.

Regulation 2

SCHEDULE 1 TEXT OF ANNEX I TO THE DIRECTIVE

CRITERIA DETERMINING THE CLASSIFICATION OF EQUIPMENT-GROUPS INTO CATEGORIES

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 point 2.0.1 of Schedule 2.

(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 point 2.0.2 of Schedule 2.

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 point 2.1 of Schedule 2.

(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 point 2.2 of Schedule 2.

(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 point 2.3 of Schedule 2.

Regulations 6, 7, 9, 10, 13, 14, 15, 16, 23, 30 and 33

SCHEDULE 2 TEXT OF ANNEX II TO THE DIRECTIVE

ESSENTIAL HEALTH AND SAFETY REQUIREMENTS RELATING TO THE DESIGN AND CONSTRUCTION OF EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN POTENTIALLY EXPLOSIVE ATMOSPHERES

Preliminary observations

A. Technological knowledge, which can change rapidly, must be taken into account as far as possible and be utilised immediately.

B. For devices the essential requirements shall apply only in so far as they are necessary for the safe and reliable functioning and operation of those devices with respect to the risks of explosion.

1. Common requirements for equipment and protective systems

1.0. General requirements

1.0.1. Principles of integrated explosion safety

Equipment and protective systems intended for use in potentially explosive atmospheres must be designed from the point of view of integrated explosion safety.

In this connection, the manufacturer must take measures:

— above all, if possible, to prevent the formation of explosive atmospheres which may be produced or released by equipment and by protective systems themselves,

— to prevent the ignition of explosive atmospheres, taking into account the nature of every electrical and non-electrical source of ignition,

— should an explosion nevertheless occur which could directly or indirectly endanger persons and, as the case may be, domestic animals or property, to halt it immediately and/or to limit the range of explosion flames and explosion pressures to a sufficient level of safety.

1.0.2. Equipment and protective systems must be designed and manufactured after due analysis of possible operating faults in order as far as possible to preclude dangerous situations.

Any misuse which can reasonably be anticipated must be taken into account.

1.0.3. Special checking and maintenance conditions

Equipment and protective systems subject to special checking and maintenance conditions must be designed and constructed with such conditions in mind.

1.0.4. Surrounding area conditions

Equipment and protective systems must be so designed and constructed as to be capable of coping with actual or foreseeable surrounding area conditions.

1.0.5. Marking

All equipment and protective systems must be marked legibly and indelibly with the following minimum particulars:

— name, registered trade name or registered trade mark, and address of the manufacturer,

— CE marking, (see Annex II to Regulation (EC) No 765/2008),

— designation of series or type,

— batch or serial number, if any,

— year of construction,

— the specific marking of explosion protection [image omitted] followed by the symbol of the equipment group and category,

— for equipment-group II, the letter “G” (concerning explosive atmospheres caused by gases, vapours or mists),

— the letter “D” (concerning explosive atmospheres caused by dust), or both such letters.

Furthermore, where necessary, they must also be marked with all information essential to their safe use.

1.0.6. Instructions

(a) All equipment and protective systems must be accompanied by instructions, including at least the following particulars:

— a recapitulation of the information with which the equipment or protective system is marked, except for the batch or serial number (see point 1.0.5), together with any appropriate additional information to facilitate maintenance (e.g. address of the repairer, etc.);

— instructions for safe:

— putting into service,

— use,

— assembling and dismantling,

— maintenance (servicing and emergency repair),

— installation,

— adjustment;

— where necessary, an indication of the danger areas in front of pressure-relief devices;

— where necessary, training instructions;

— details which allow a decision to be taken beyond any doubt as to whether an item of equipment in a specific category or a protective system can be used safely in the intended area under the expected operating conditions;

— electrical and pressure parameters, maximum surface temperatures and other limit values;

— where necessary, special conditions of use, including particulars of possible misuse which experience has shown might occur;

— where necessary, the essential characteristics of tools which may be fitted to the equipment or protective system.

(b) The instructions must contain the drawings and diagrams necessary for the putting into service, maintenance, inspection, checking of correct operation and, where appropriate, repair of the equipment or protective system, together with all useful instructions, in particular with regard to safety.

(c) Literature describing the equipment or protective system must not contradict the instructions with regard to safety aspects.

1.1. Selection of materials

1.1.1. The materials used for the construction of equipment and protective systems must not trigger off an explosion, taking into account foreseeable operational stresses.

1.1.2. Within the limits of the operating conditions laid down by the manufacturer, it must not be possible for a reaction to take place between the materials used and the constituents of the potentially explosive atmosphere which could impair explosion protection.

1.1.3. Materials must be so selected that predictable changes in their characteristics and their compatibility in combination with other materials will not lead to a reduction in the protection afforded; in particular, due account must be taken of the material’s corrosion and wear resistance, electrical conductivity, mechanical strength, ageing resistance and the effects of temperature variations.

1.2. Design and Construction

1.2.1. Equipment and protective systems must be designed and constructed with due regard to technological knowledge of explosion protection so that they can be safely operated throughout their foreseeable lifetime.

1.2.2. Components to be incorporated into or used as replacements in equipment and protective systems must be so designed and constructed that they function safely for their intended purpose of explosion protection when they are installed in accordance with the manufacturer’s instructions.

1.2.3. Enclosed structure and prevention of leaks

Equipment which may release flammable gases or dusts must wherever possible employ enclosed structures only.

If equipment contains openings or non-tight joints, these must as far as possible be designed in such a way that releases of gases or dusts cannot give rise to explosive atmospheres outside the equipment.

Points where materials are introduced or drawn off must, as far as possible, be designed and equipped so as to limit escapes of flammable materials during filling or draining.

1.2.4. Dust deposits

Equipment and protective systems which are intended to be used in areas exposed to dust must be so designed that deposit dust on their surfaces is not ignited.

In general, dust deposits must be limited where possible. Equipment and protective systems must be easily cleanable.

The surface temperatures of equipment parts must be kept well below the glow temperature of the deposit dust.

The thickness of deposit dust must be taken into consideration and, if appropriate, means must be taken to limit the temperature in order to prevent a heat build up.

1.2.5. Additional means of protection

Equipment and protective systems which may be exposed to certain types of external stresses must be equipped, where necessary, with additional means of protection.

Equipment must withstand relevant stresses, without adverse effect on explosion protection.

1.2.6. Safe opening

If equipment and protective systems are in a housing or a locked container forming part of the explosion protection itself, it must be possible to open such housing or container only with a special tool or by means of appropriate protection measures.

1.2.7. Protection against other hazards

Equipment and protective systems must be so designed and manufactured as to:

(a) avoid physical injury or other harm which might be caused by direct or indirect contact;

(b) assure that surface temperatures of accessible parts or radiation which would cause a danger, are not produced;

(d) assure that foreseeable conditions of overload shall not give rise to dangerous situations.

Where, for equipment and protective systems, the risks referred to in this point are wholly or partly covered by other Union legislation these Regulations shall not apply or shall cease to apply in the case of such equipment and protective systems and of such risks upon application of that specific Union legislation.

1.2.8. Overloading of equipment

Dangerous overloading of equipment must be prevented at the design stage by means of integrated measurement, regulation and control devices, such as over-current cut-off switches, temperature limiters, differential pressure switches, flowmeters, time-lag relays, overspeed monitors and/or similar types of monitoring devices.

1.2.9. Flameproof enclosure systems

If parts which can ignite an explosive atmosphere are placed in an enclosure, measures must be taken to ensure that the enclosure withstands the pressure developed during an internal explosion of an explosive mixture and prevents the transmission of the explosion to the explosive atmosphere surrounding the enclosure.

1.3. Potential ignition sources

1.3.1. Hazards arising from different ignition sources

Potential ignition sources such as sparks, flames, electric arcs, high surface temperatures, acoustic energy, optical radiation, electromagnetic waves and other ignition sources must not occur.

1.3.2. Hazards arising from static electricity

Electrostatic charges capable of resulting in dangerous discharges must be prevented by means of appropriate measures.

1.3.3. Hazards arising from stray electric and leakage currents

Stray electric and leakage currents in conductive equipment parts which could result in, for example, the occurrence of dangerous corrosion, overheating of surfaces or sparks capable of provoking an ignition must be prevented.

1.3.4. Hazards arising from overheating

Overheating caused by friction or impacts occurring, for example, between materials and parts in contact with each other while rotating or through the intrusion of foreign bodies must, as far as possible, be prevented at the design stage.

1.3.5. Hazards arising from pressure compensation operations

Equipment and protective systems must be so designed or fitted with integrated measuring, control and regulation devices that pressure compensations arising from them do not generate shock waves or compressions which may cause ignition.

1.4. Hazards arising from external effects

1.4.1. Equipment and protective systems must be so designed and constructed as to be capable of performing their intended function in full safety, even in changing environmental conditions and in the presence of extraneous voltages, humidity, vibrations, contamination and other external effects, taking into account the limits of the operating conditions established by the manufacturer.

1.4.2. Equipment parts used must be appropriate to the intended mechanical and thermal stresses and capable of withstanding attack by existing or foreseeable aggressive substances.

1.5. Requirements in respect of safety-related devices

1.5.1. Safety devices must function independently of any measurement and/or control devices required for operation.

As far as possible, failure of a safety device must be detected sufficiently rapidly by appropriate technical means to ensure that there is only very little likelihood that dangerous situations will occur.

The fail-safe principle is to be applied in general.

Safety-related switching must in general directly actuate the relevant control devices without intermediate software command.

1.5.2. In the event of a safety device failure, equipment and/or protective systems shall, wherever possible, be secured.

1.5.3. Emergency stop controls of safety devices must, as far as possible, be fitted with restart lockouts. A new start command may take effect on normal operation only after the restart lockouts have been intentionally reset.

1.5.4. Control and display units

Where control and display units are used, they must be designed in accordance with ergonomic principles in order to achieve the highest possible level of operating safety with regard to the risk of explosion.

1.5.5. Requirements in respect of devices with a measuring function for explosion protection

In so far as they relate to equipment used in explosive atmospheres, devices with a measuring function must be designed and constructed so that they can cope with foreseeable operating requirements and special conditions of use.

1.5.6. Where necessary, it must be possible to check the reading accuracy and serviceability of devices with a measuring function.

1.5.7. The design of devices with a measuring function must incorporate a safety factor which ensures that the alarm threshold lies far enough outside the explosion and/or ignition limits of the atmospheres to be registered, taking into account, in particular, the operating conditions of the installation and possible aberrations in the measuring system.

1.5.8. Risks arising from software

In the design of software-controlled equipment, protective systems and safety devices, special account must be taken of the risks arising from faults in the programme.

1.6. Integration of safety requirements relating to the system

1.6.1. Manual override must be possible in order to shut down the equipment and protective systems incorporated within automatic processes which deviate from the intended operating conditions, provided that this does not compromise safety.

1.6.2. When the emergency shutdown system is actuated, accumulated energy must be dispersed as quickly and as safely as possible or isolated so that it no longer constitutes a hazard.

This does not apply to electrochemically-stored energy.

1.6.3. Hazards arising from power failure

Where equipment and protective systems can give rise to a spread of additional risks in the event of a power failure, it must be possible to maintain them in a safe state of operation independently of the rest of the installation.

1.6.4. Hazards arising from connections

Equipment and protective systems must be fitted with suitable cable and conduit entries.

When equipment and protective systems are intended for use in combination with other equipment and protective systems, the interface must be safe.

1.6.5. Placing of warning devices as parts of equipment

Where equipment or protective systems are fitted with detection or alarm devices for monitoring the occurrence of explosive atmospheres, the necessary instructions must be provided to enable them to be provided at the appropriate places.

2. Supplementary requirements in respect of equipment

2.0. Requirements applicable to equipment in category M of equipment-group I.

2.0.1. Requirements applicable to equipment in category M 1 of equipment-group I.

2.0.1.1. Equipment must be so designed and constructed that sources of ignition do not become active, even in the event of rare incidents relating to equipment.

Equipment must be equipped with 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 ensured in the event of two faults occurring independently of each other.

Where necessary, this equipment must be equipped with additional special means of protection.

It must remain functional with an explosive atmosphere present.

2.0.1.2. Where necessary, equipment must be so constructed that no dust can penetrate it.

2.0.1.3. The surface temperatures of equipment parts must be kept clearly below the ignition temperature of the foreseeable air/dust mixtures in order to prevent the ignition of suspended dust.

2.0.1.4. Equipment must be so designed that the opening of equipment parts which may be sources of ignition is possible only under non-active or intrinsically safe conditions. Where it is not possible to render equipment non-active, the manufacturer must affix a warning label to the opening part of the equipment.

If necessary, equipment must be fitted with appropriate additional interlocking systems.

2.0.2. Requirements applicable to equipment in category M 2 of equipment-group I.

2.0.2.1. Equipment must be equipped with means of protection ensuring that sources of ignition do not become active during normal operation, even under more severe operating conditions, in particular those arising from rough handling and changing environmental conditions.

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

2.0.2.2. Equipment must be so designed that the opening of equipment parts which may be sources of ignition is possible only under non-active conditions or via appropriate interlocking systems. Where it is not possible to render equipment non-active, the manufacturer must affix a warning label to the opening part of the equipment.

2.0.2.3. The requirements regarding explosion hazards arising from dust applicable to category M 1 must be applied.

2.1. Requirements applicable to equipment in category 1 of equipment-group II.

2.1.1. Explosive atmospheres caused by gases, vapours or mists.

2.1.1.1. Equipment must be so designed and constructed that sources of ignition do not become active, even in event of rare incidents relating to equipment.

It must be equipped with 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 ensured in the event of two faults occurring independently of each other.

2.1.1.2. For equipment with surfaces which may heat up, measures must be taken to ensure that the stated maximum surface temperatures are not exceeded even in the most unfavourable circumstances.

Temperature rises caused by heat build-ups and chemical reactions must also be taken into account.

2.1.1.3. Equipment must be so designed that the opening of equipment parts which might be sources of ignition is possible only under non-active or intrinsically safe conditions. Where it is not possible to render equipment non-active, the manufacturer must affix a warning label to the opening part of the equipment.

If necessary, equipment must be fitted with appropriate additional interlocking systems.

2.1.2. Explosive atmospheres caused by air/dust mixtures.

2.1.2.1. Equipment must be so designed and constructed that ignition of air/dust mixtures does not occur even in the event of rate incidents relating to equipment.

It must be equipped with 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 ensured in the event of two faults occurring independently of each other.

2.1.2.2. Where necessary, equipment must be so designed that dust can enter or escape from the equipment only at specifically designated points.

This requirement must also be met by cable entries and connecting pieces.

2.1.2.3. The surface temperatures of equipment parts must be kept well below the ignition temperature of the foreseeable air/dust mixtures in order to prevent the ignition of suspended dust.

2.1.2.4. With regard to the safe opening of equipment parts, requirement 2.1.1.3 applies.

2.2. Requirements for category 2 of equipment-group II.

2.2.1. Explosive atmospheres caused by gases, vapours or mists.

2.2.1.1. Equipment must be so designed and constructed as to prevent ignition sources arising, even in the event of frequently occurring disturbances or equipment operating faults, which normally have to be taken into account.

2.2.1.2. Equipment parts must be so designed and constructed that their stated surface temperatures are not exceeded, even in the case of risks arising from abnormal situations anticipated by the manufacturer.

2.2.1.3. Equipment must be so designed that the opening of equipment parts which might be sources of ignition is possible only under non-active conditions or via appropriate interlocking systems. Where it is not possible to render equipment non-active, the manufacturer must affix a warning label to the opening part of the equipment.

2.2.2. Explosive atmospheres caused by air/dust mixtures.

2.2.2.1. Equipment must be designed and constructed so that ignition of air/dust mixtures is prevented, even in the event of frequently occurring disturbances or equipment operating faults which normally have to be taken into account.

2.2.2.2. With regard to surface temperatures, requirement 2.1.2.3 applies.

2.2.2.3. With regard to protection against dust, requirement 2.1.2.2 applies.

2.2.2.4. With regard to the safe opening of equipment parts, requirement 2.2.1.3 applies.

2.3. Requirements applicable to equipment in category 3 of equipment-group II.

2.3.1. Explosive atmospheres caused by gases, vapours or mists.

2.3.1.1. Equipment must be so designed and constructed as to prevent foreseeable ignition sources which can occur during normal operation.

2.3.1.2. Surface temperatures must not exceed the stated maximum surface temperatures under intended operating conditions. Higher temperatures in exceptional circumstances may be allowed only if the manufacturer adopts special additional protective measures.

2.3.2. Explosive atmospheres caused by air/dust mixtures.

2.3.2.1. Equipment must be so designed and constructed that air/dust mixtures cannot be ignited by foreseeable ignition sources likely to exist during normal operation.

2.3.2.2. With regard to surface temperatures, requirement 2.1.2.3 applies.

2.3.2.3. Equipment, including cable entries and connecting pieces, must be so constructed that, taking into account the size of its particles, dust can neither develop explosive mixtures with air nor form dangerous accumulation inside the equipment.

3. Supplementary requirements in respect of protective systems

3.0. General requirements

3.0.1. Protective systems must be dimensioned in such a way as to reduce the effects of an explosion to a sufficient level of safety.

3.0.2. Protective systems must be designed and capable of being positioned in such a way that explosions are prevented from spreading through dangerous chain reactions or flashover and incipient explosions do not become detonations.

3.0.3. In the event of a power failure, protective systems must retain their capacity to function for a period sufficient to avoid a dangerous situation.

3.0.4. Protective systems must not fail due to outside interference.

3.1. Planning and design

3.1.1. Characteristics of materials

With regard to the characteristics of materials, the maximum pressure and temperature to be taken into consideration at the planning stage are the expected pressure during an explosion occurring under extreme operating conditions and the anticipated heating effect of the flame.

3.1.2. Protective systems designed to resist or contain explosions must be capable of withstanding the shock wave produced without losing system integrity.

3.1.3. Accessories connected to protective systems must be capable of withstanding the expected maximum explosion pressure without losing their capacity to function.

3.1.4. The reactions caused by pressure in peripheral equipment and connected pipe-work must be taken into consideration in the planning and design of protective systems.

3.1.5. Pressure relief systems

If it is likely that stresses on protective systems will exceed their structural strength, provision must be made in the design for suitable pressure-relief devices which do not endanger persons in the vicinity.

3.1.6. Explosion suppression systems

Explosion suppression systems must be so planned and designed that they react to an incipient explosion at the earliest possible stage in the event of an incident and counteract it to best effect, with due regard to the maximum rate of pressure increase and the maximum explosion pressure.

3.1.7. Explosion decoupling systems

Decoupling systems intended to disconnect specific equipment as swiftly as possible in the event of incipient explosions by means of appropriate devices must be planned and designed so as to remain proof against the transmission of internal ignition and to retain their mechanical strength under operating conditions.

3.1.8. Protective systems must be capable of being integrated into a circuit with a suitable alarm threshold so that, if necessary, there is cessation of product feed and output and shutdown of equipment parts which can no longer function safely.

Regulations 7, 14, 15 and 23

SCHEDULE 3 TEXT OF ANNEX III TO THE DIRECTIVE

MODULE B EU-TYPE EXAMINATION

EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of a product and verifies and attests that the technical design of the product meets the requirements of the Directive that apply to it.

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

The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice.

The application shall include:

(a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

(b) a written declaration that the same application has not been lodged with any other notified body,

(c) the technical documentation. The technical documentation shall make it possible to assess the product’s conformity with the applicable requirements of the Directive 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:

(i) a general type-description;

(ii) design and manufacturing drawings and layouts of components, sub-assemblies, circuits, etc.;

(iii) descriptions and explanations necessary for the understanding of said drawings and layouts and the operation of the product;

(iv) a list of the standards referred to in these Regulations, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of these Regulations where the standards referred to have not been applied;

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

(vi) test reports.

(d) the specimens representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme.

The notified body shall:

4.1. 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 harmonised standards, as well as the elements which have been designed in accordance with other relevant technical specifications;

4.2. 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 harmonised standards, these have been applied correctly;

4.3 carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised 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 the Directive;

4.4 agree with the applicant the location where the examinations and necessary tests shall be carried out.

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

Where the type meets the requirements of the Directive that apply to the product concerned, the notified body shall issue an EU-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 EU-type examination certificate may have one or more annexes attached.

The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products with the examined type to be evaluated and to allow for in-service control.

Where the type does not satisfy the applicable requirements of the Directive, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

The notified body shall keep itself appraised 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 the Directive, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the product with the essential health and safety requirements of the Directive or the conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate.

Each notified body shall inform its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued.

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate.

The manufacturer shall keep a copy of the EU-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 point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.

Regulations 7, 14, 15 and 23

SCHEDULE 4 TEXT OF ANNEX IV TO THE DIRECTIVE

MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS

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 points 2 and 5, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of the Directive that apply to them.

2. Manufacturing

The manufacturer shall operate an approved quality system for production, final equipment inspection and testing as specified in paragraph 3 and shall be subject to monitoring as specified in paragraph 4.

3. Quality system.

3.1 The manufacturer shall lodge an application for assessment of his quality system with a notified body of his choice, for the equipment concerned.

The application shall include:

(a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

(b) a written declaration that the same application has not been lodged with any other notified body,

(d) the documentation concerning the quality system,

(e) the technical documentation of the approved type and a copy of the EU-type examination certificate.

3.2 The quality system shall ensure compliance of the equipment with the type as described in the EU-type-examination certificate and with the requirements of these Regulations which apply to them.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation must permit a consistent interpretation of quality programmes, plans, manuals and records.

It shall contain, in particular, an adequate description of:

(a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to equipment quality;

(b) the manufacturing, quality control and quality assurance techniques, processes and systematic actions which will be used;

(c) the examinations and tests which will be carried out before, during and after manufacture and the frequency with which they will be carried out;

(d) the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.;

(e) the means to monitor the achievement of the required equipment quality and the effective operation of the quality system.

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

It shall presume conformity with these requirements in respect of quality systems that comply with the corresponding specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of the Directive. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 3.1(e) to verify the manufacturer’s ability to identify the relevant requirements of the Directive and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

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

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

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

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

4. Surveillance under the responsibility of the notified body

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

4.2. The manufacturer shall, for assessment purposes, allow the notified 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.

4.3. The notified 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.

4.4. In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified 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 notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

5. CE marking, EU declaration of conformity and attestation of conformity

5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 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 EU-type examination certificate and satisfies the applicable requirements of the Directive.

5.2. The manufacturer shall draw up a written EU 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 EU declaration of conformity shall identify such product model for which it has been drawn up.

A copy of the EU declaration of conformity shall accompany every product, other than a component.

5.3. 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.

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 point 3.1,

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

Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.

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