S.I. No. 232/2017 - European Union (Lifts and Safety Components for Lifts) Regulations 2017

ARRANGEMENT OF REGULATIONS

PART 1 CITATION, INTERPRETATION

1.

2.

3.

4.

5.

6.

7.

PART 2 OBLIGATIONS OF ECONOMIC OPERATORS

8.

9.

10.

11.

12.

13.

14.

PART 3 CONFORMITY OF PRODUCTS

15.

16.

17.

18.

19.

20.

PART 4 NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

21.

22.

23.

24.

25.

26.

27.

28.

PART 5 MARKET SURVEILLANCE, SAFEGUARD PROCEDURE

29.

30.

31.

32.

33.

PART 6 POWERS OF THE MARKET SURVEILLANCE AUTHORITY

34.

35.

36.

37.

38.

39.

40.

41.

42.

43.

44.

PART 7 OFFENCES AND PENALTIES

45.

46.

47.

48.

PART 8 MISCELLANEOUS

49.

50.

51.

52.

53.

54.

55.

SCHEDULE 1 TEXT OF ANNEX I TO THE DIRECTIVE

ESSENTIAL HEALTH AND SAFETY REQUIREMENTS.

SCHEDULE 2 TEXT OF ANNEX II TO THE DIRECTIVE

A. Content of the EU declaration of conformity for safety components for lifts, B. Content of the EU declaration of conformity for lifts.

SCHEDULE 3 TEXT OF ANNEX III TO THE DIRECTIVE

LIST OF SAFETY COMPONENTS FOR LIFTS.

SCHEDULE 4 TEXT OF ANNEX IV TO THE DIRECTIVE

EU-TYPE EXAMINATION FOR LIFTS AND SAFETY COMPONENTS FOR LIFTS (MODULE B).

SCHEDULE 5 TEXT OF ANNEX V TO THE DIRECTIVE

FINAL INSPECTION FOR LIFTS.

SCHEDULE 6 TEXT OF ANNEX VI TO THE DIRECTIVE

CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE FOR SAFETY COMPONENTS FOR LIFTS (MODULE E).

SCHEDULE 7 TEXT OF ANNEX VII TO THE DIRECTIVE

CONFORMITY BASED ON FULL QUALITY ASSURANCE FOR SAFETY COMPONENTS FOR LIFTS (MODULE H).

SCHEDULE 8 TEXT OF ANNEX VIII TO THE DIRECTIVE

CONFORMITY BASED ON UNIT VERIFICATION FOR LIFTS (MODULE G).

SCHEDULE 9 TEXT OF ANNEX IX TO THE DIRECTIVE

CONFORMITY TO TYPE WITH RANDOM CHECKING FOR SAFETY COMPONENTS FOR LIFTS (MODULE C 2).

SCHEDULE 10 TEXT OF ANNEX X TO THE DIRECTIVE

CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE FOR LIFTS (MODULE E).

SCHEDULE 11 TEXT OF ANNEX XI TO THE DIRECTIVE

CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION FOR LIFTS (MODULE H1).

SCHEDULE 12 TEXT OF ANNEX XII TO THE DIRECTIVE

CONFORMITY TO TYPE BASED ON PRODUCTION QUALITY ASSURANCE FOR LIFTS (MODULE D).

SCHEDULE 13 TEXT OF ANNEX XIV TO THE DIRECTIVE

CORRELATION TABLE.

S.I. No. 232 of 2017

EUROPEAN UNION (LIFTS AND SAFETY COMPONENTS FOR LIFTS) REGULATIONS 2017

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 2nd June, 2017.

I, MARY MITCHELL O’CONNOR, Minister for Jobs, Enterprise and Innovation, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) (as amended by section 2 of the European Communities Act 2007 (No. 18 of 2007)) and for the purpose of giving effect to Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014¹ and of giving further effect to Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008² , hereby make the following regulations:

PART 1 CITATION, INTERPRETATION

Citation

• (2) These Regulations (other than Regulation 7(3)) come into operation on the day of their making.

• (3) Regulation 7(3) comes into operation from 1 November 2017.

Interpretation

“accreditation” has the meaning assigned to it in point 10 of Article 2 of Regulation (EC) No. 765/2008;

“Act of 2005” means the Safety, Health and Welfare at Work Act 2005 (No. 10 of 2005);

“authorised representative” means any natural or legal person established within the European Economic Area who has received a written mandate from an installer or a manufacturer to act on its behalf in relation to specified tasks;

“carrier” means a part of the lift by which persons or goods or both are supported in order to be lifted or lowered;

“CE marking” means a marking by which the installer or the manufacturer indicates that the product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;

“Companies Acts” means the Companies Act 2014 (No. 38 of 2014) or, as the context may require, the legislation repealed by s. 4 of the Companies Act 2014 ;

“competent authority” means—

• (a) in the State, the market surveillance authority, or

• (b) in another Member State, any authority or body to whom functions have been assigned as a competent authority or a market surveillance authority, for the purposes of the Directive;

“conformity assessment” means the process demonstrating whether the essential health and safety requirements of the Directive or these Regulations relating to a product have been fulfilled;

“conformity assessment body” means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

“contravention notice” means the notice provided for in Regulation 37;

“Coroners Acts 1962 and 2005” means the Coroners Act 1962 (No. 9 of 1962) as amended by the Coroners (Amendment) Act 2005 (No. 33 of 2005);

“Directive” means Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014;

“Directive 95/16/EC” means European Parliament and Council Directive 95/16/EC of 29 June 1995³

“distributor” means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a safety component available on the market;

“economic operator” means an installer, manufacturer, authorised representative, importer or distributor;

“EU declaration of conformity” means a declaration drawn up in accordance with Regulation 18;

“harmonised standard” has the meaning assigned to it in point (c) of point 1 of Article 2 of Regulation (EU) No. 1025/2012 of the European Parliament and of the Council of 25 October 2012⁴

“importer” means any natural or legal person established within the European Economic Area who places a safety component from a third country on the market of the European Economic Area;

“impossible” means, in the context of prior approval for reduced headroom lifts, that it is not possible using up to date engineering practice to install the required refuge space without having to modify the existing foundations of the building or breach requirements related to heritage preservation;

“information notice” means the notice provided for in Regulation 42;

“inspector” has the meaning assigned to it in Regulation 34(2);

“installer” means the natural or legal person who takes responsibility for the design, manufacture, installation and placing on the market of the lift;

“Irish National Accreditation Board” means the national body with responsibility for the accreditation of laboratories, certification bodies and inspection bodies, and notified to the European Commission as being the sole accreditation body for Ireland in line with Regulation (EC) No 765/2008;

“lift” means a lifting appliance serving specific levels, having a carrier moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal, or a lifting appliance moving along a fixed course even where it does not move along rigid guides;

“making available on the market” means any supply of a safety component for distribution or use on the market of the European Economic Area in the course of a commercial activity, whether in return for payment or free of charge;

“manufacturer” means any natural or legal person who manufactures a safety component or has a safety component designed or manufactured, and markets it under its name or trademark;

“market surveillance authority” means the authority designated as a market surveillance authority under Regulation 3;

“Member State” means a state which is a contracting party to the Agreement on the European Economic Area signed in Oporto on 2 May 1992;

“Minister” means the Minister for Jobs, Enterprise and Innovation;

“model lift” means a representative lift whose technical documentation shows the way in which the essential health and safety requirements set out in Annex I, the text of which is set out in Schedule 1 to these Regulations, will be met for lifts which conform to the model lift defined by objective parameters and which uses identical safety components;

“notified body” means—

• (a) in the State, a conformity assessment body notified by the notifying authority pursuant to Regulation 21, and

• (b) in another Member State, a conformity assessment body notified by the relevant notifying authority pursuant to the Directive;

“notifying authority” means the authority designated as the notifying authority in the State under Regulation 3 and in another Member State the authority designated as notifying authority pursuant to the Directive;

“Official Journal” means the Official Journal of the European Union;

“person in charge” means, in relation to a place—

• (a) the person under whose direction and control the activities at that place are being conducted, or

• (b) the person whom the inspector has reasonable grounds for believing is in control of that place;

“placing on the market” means—

• (a) the first making available on the market of a safety component, or

• (b) the supply of a lift for use on the market of the European Economic Area in the course of a commercial activity, whether in return for payment or free of charge;

“premises of an economic operator” means any premises owned or being used by an economic operator;

“prohibition notice” means the notice provided for in Regulation 39;

“product” means any lift or safety component;

“putting into service” means the first use of a product by its user;

“recall” in relation to a lift means any measure aimed at achieving the dismantling and safe disposal of a lift, and in relation to a safety component means any measure aimed at achieving the return of a safety component that has already been made available to the installer or to the end-user;

“Regulations of 1998” means means the European Communities (Lifts) Regulations ( S.I. No. 246 of 1998 ) as amended by the European Communities (Lifts) (Amendment) Regulations 2008 ( S.I. No. 406 of 2008 );

“Regulation (EC) No. 765/2008” means Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the equirements or accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No. 993/93;

“safety component” means a safety component for a lift;

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

“Union harmonisation legislation” means any European Union legislation harmonising the conditions for the marketing of products;

“withdrawal” means any measure aimed at preventing a safety component in the supply chain from being made available on the market.

• (2) A word or expression which is used in these Regulations and which is also used in the Directive has, unless the context otherwise requires, the same meaning in these Regulations as it has in the Directive.

• (3) References to the repealed Directive 95/16/EC shall be construed in existing laws, regulations and administrative provisions of the State as references to the Directive and shall be read in accordance with the correlation table in Annex XIV to the Directive, the text of which is set out in Schedule 13 to these Regulations.

Designation

• (a) the Health and Safety Authority is designated as the market surveillance authority, and

• (b) the Minister is designated as the notifying authority.

Application

• (a) lifts permanently serving buildings and constructions and intended for the transport of—

• (i) persons,

• (ii) persons and goods,

• (iii) goods alone if the carrier is accessible, that is to say a person may enter it without difficulty, and fitted with controls situated inside the carrier or within reach of a person inside the carrier, and

• (b) the safety components listed in Schedule 3 for use in the lifts referred to in subparagraph (a) of this Regulation.

• (2) These Regulations do not apply to—

• (a) lifting appliances whose speed is not greater than 0.15 m/s,

• (b) construction site hoists,

• (c) cableways, including funicular railways,

• (d) lifts specially designed and constructed for military or police purposes,

• (e) lifting appliances from which work can be carried out,

• (f) mine winding gear,

• (g) lifting appliances intended for lifting performers during artistic performances,

• (h) lifting appliances fitted in means of transport,

• (i) lifting appliances connected to machinery and intended exclusively for access to workstations including maintenance and inspection points on the machinery,

• (j) rack and pinion trains, and

• (k) escalators and mechanical walkways.

• (3) In a case where for lifts or safety components, the risks referred to in these Regulations are wholly or partly covered by specific European Union law, these Regulations do not apply or shall cease to apply in the case of such lifts or safety components and such risks as from the application of that specific European Union law.

Making available on the market and putting into service

• (a) place on the market or put into service any lift unless it complies with the Directive or these Regulations when properly installed and maintained and used for its intended purpose, or

• (b) make available on the market or put into service any safety component unless it complies with the Directive or these Regulations when properly incorporated and maintained and used for its intended purpose.

• (2) Paragraph (1) shall not prevent a person from showing a lift or a safety component which does not comply with the Directive or these Regulations at a trade fair, exhibition or demonstration, provided that—

• (a) a visible sign clearly indicates that the lift or safety component does not comply with the Directive or these Regulations and that it will not be placed or made available on the market until they have been brought into conformity, and

• (b) adequate safety measures are taken during demonstrations to ensure the protection of persons.

Essential health and safety requirements

• (2) Safety components shall satisfy the essential health and safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations and enable the lifts in which they are incorporated to satisfy those requirements.

Buildings or constructions in which lifts are installed and prior approval for installation of reduced headroom lifts

• (2) A person shall not install or cause to be installed piping, wiring or fittings in a lift shaft other than the piping, wiring or fittings necessary for the operation and safety of the lift.

• (3) Notwithstanding point 2.2 of Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations, and in light of the third sentence thereto, where it is impossible to have a refuge or free space beyond the extreme positions of a lift, a person may commence the installation of the lift with reduced headroom after he or she has sought, and been granted, written prior approval from the Minister.

PART 2 OBLIGATIONS OF ECONOMIC OPERATORS

Obligations of installers

• (a) ensure that a lift placed on the market by the installer has been designed, manufactured, installed and tested in accordance with the essential health and safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations,

• (b) draw up the technical documentation and carry out, or have carried out, the relevant conformity assessment procedure referred to in Regulation 17,

• (c) in a case where compliance with the applicable essential health and safety requirements has been demonstrated by the conformity assessment procedure carried out under paragraph (b)—

• (i) draw up an EU declaration of conformity,

• (ii) ensure that the EU declaration of conformity accompanies the lift, and

• (iii) affix a CE marking to the lift in accordance with Regulation 20,

• (d) retain the technical documentation, the EU declaration of conformity and, where applicable, the approval decision(s) for 10 years after the lift has been placed on the market,

• (e) in a case where it is deemed appropriate by the market surveillance authority, with regard to the risks presented by the lift and in order to protect the health and safety of consumers, investigate and, if necessary, keep a register of complaints and of non-conforming lifts,

• (f) ensure that the lift bears a type, batch or serial number or other element allowing its identification,

• (g) indicate on the lift, in a language easily understood by end-users and the market surveillance authority, the installer’s name, registered trade name or registered trade mark and the postal address at which the installer can be contacted, which address shall indicate a single point at which the installer can be contacted,

• (h) ensure that the lift is accompanied by the instructions referred to in point 6.2 of Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations, in a language which can be easily understood by end-users and that such instructions, as well as any labelling, are clear, understandable and intelligible,

• (i) in the case of a lift which the installer has placed on the market and which the installer considers or has reason to believe is not in conformity with the Directive or these Regulations—

• (i) immediately take the corrective measures necessary to bring that lift into conformity with the Directive or these Regulations, and

• (ii) where the lift presents a risk, immediately inform the competent authorities of the Member States in which the installer placed the lift on the market to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken, and

• (j) further to a reasoned request from a competent authority in respect of a lift which the installer has made placed on the market—

• (i) provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the lift with the Directive or these Regulations, in a language which can be easily understood by that authority, and

• (ii) cooperate with that authority, at its request, on any action taken to eliminate the risks posed by lifts placed on the market by the installer.

Obligations of manufacturers

• (a) ensure that safety components placed on the market by the manufacturer have been designed and manufactured so as to satisfy the essential health and safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations and that they enable lifts in which they are incorporated to satisfy those requirements,

• (b) draw up the required technical documentation and carry out, or have carried out, the relevant conformity assessment procedure referred to in Regulation 16,

• (c) in a case where compliance of a safety component with the applicable essential health and safety requirements has been demonstrated by the conformity assessment procedure carried out under paragraph (b)—

• (i) draw up an EU declaration of conformity in accordance with Regulation 18,

• (ii) ensure that the EU declaration of conformity accompanies the safety component, and

• (iii) affix the CE marking in accordance with Regulation 20,

• (d) retain the technical documentation, the EU declaration of conformity and, where applicable, the approval decision(s) for 10 years after the safety component has been placed on the market,

• (e) ensure that procedures are in place for series production to remain in conformity with the Directive or these Regulations and that changes in product design or characteristics, and changes in the harmonised standards referred to in Regulation 15 or in other technical specifications by reference to which conformity of a safety component is declared, are adequately taken into account,

• (f) in a case where it is deemed appropriate by the market surveillance authority, with regard to the risks presented by a safety component and in order to protect the health and safety of consumers—

• (i) carry out sample testing of safety components made available on the market,

• (ii) investigate, and, if necessary, keep a register of complaints, of non-conforming safety components and recalls of safety components, and

• (iii) keep distributors and installers informed of any such monitoring,

• (g) ensure that safety components which the manufacturer has placed on the market bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the safety component does not allow it, that the required information is provided on the label referred to in Regulation 20(2),

• (h) indicate on the safety component, in a language easily understood by end-users and competent authorities, the manufacturer’s name, registered trade name or registered trade mark and the postal address at which they can be contacted, which address shall indicate a single point of contact or, where it is not possible to do so on the component, on the label referred to in Regulation 20(2),

• (i) ensure that the safety component is accompanied by the instructions referred to in point 6.1 of Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations, in a language which can be easily understood by end-users and that such instructions, as well as any labelling, are clear, understandable and intelligible,

• (j) in the case of a safety component which the manufacturer has placed on the market and which the manufacturer considers or has reason to believe is not in conformity with the Directive or these Regulations—

• (i) immediately take the corrective measures necessary to bring that safety component into conformity, to withdraw it or recall it, if appropriate, and

• (ii) where the safety component presents a risk, immediately inform the competent authorities of the Member States in which the manufacturer made the component available on the market, giving details, in particular, of the non-conformity and of any corrective measures taken,

and

• (k) further to a reasoned request from a competent authority in respect of a component which the manufacturer has placed on the market—

• (i) provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the safety component with the Directive or these Regulations, in a language easily understood by that authority, and

• (ii) cooperate with that authority, at its request, on any action taken to eliminate the risks posed by safety components placed on the market by the manufacturer.

Authorised representatives

• (2) The obligations laid down in Regulations 8(a) and 9(a) and the obligation to draw up technical documentation referred to in Regulation 8(b) and 9(b), shall not form part of the mandate of an authorised representative appointed under paragraph (1).

• (3) An authorised representative appointed under paragraph (1) shall perform the tasks specified in the mandate received from the manufacturer or installer which shall, at least, allow the authorised representative to—

• (a) keep the EU declaration of conformity and, where applicable, the approval decision(s) relating to the manufacturer’s or installer’s quality system, and the technical documentation at the disposal of competent authorities for 10 years after a safety component or lift has been placed on the market by the manufacturer or installer,

• (b) further to a reasoned request from a competent authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the safety component or lift, and

• (c) cooperate with a competent authority, at its request, on any action taken to eliminate the risks posed by the safety component or lift covered by the authorised representative’s mandate.

Obligations of importers

• (2) An importer shall—

• (a) before placing a safety component on the market, ensure that—

• (i) the appropriate conformity assessment procedure referred to in Regulation 16 has been carried out by the manufacturer,

• (ii) the manufacturer has drawn up the technical documentation,

• (iii) the safety component bears the CE marking and is accompanied by the EU declaration of conformity and the required documents, and

• (iv) the manufacturer has complied with the requirements set out in Regulation 9(g) and (h),

• (b) in a case where the importer considers or has reason to believe that a safety component is not in conformity with Regulation 6(2)—

• (i) not place the safety component on the market until it has been brought into conformity, and

• (ii) where the safety component presents a risk, inform the manufacturer and the competent authorities of the Member States to that effect,

• (c) indicate on the safety component, in a language which can be easily understood by end-users and competent authorities, or where it is not possible to do so on the component, on its packaging or in a document accompanying it, the importer’s name, registered trade name or registered trade mark and the postal address at which the importer can be contacted,

• (d) ensure that the safety component is accompanied by the instructions referred to in point 6.1 of Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations, in a language which can be easily understood by consumers and other end-users,

• (e) ensure that, while the safety component is under the importer’s responsibility, its storage or transport conditions do not jeopardise its compliance with the essential health and safety requirements referred to in Regulation 6(2),

• (f) in a case where it is deemed appropriate by the market surveillance authority, with regard to the risks presented by the safety component and in order to protect the health and safety of consumers, the importer shall—

• (i) carry out sample testing,

• (ii) investigate, and, if necessary, keep a register of complaints of, non-conforming safety components and recalls of safety components, and

• (iii) keep distributors and installers informed of any such monitoring,

• (g) in a case where the importer considers or has reason to believe that a safety component which the importer has placed on the market is not in conformity with the Directive or these Regulations—

• (i) immediately take the corrective measures necessary to bring that safety component into conformity, to withdraw it or recall it, if appropriate, and

• (ii) where the safety component presents a risk, immediately inform the competent authorities of the Member States in which the importer made the safety components available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken,

• (h) for 10 years after the safety component has been placed on the market by the importer—

• (i) keep a copy of the EU declaration of conformity and, where applicable, of the approval decision(s) at the disposal of competent authorities, and

• (ii) ensure that the technical documentation can be made available to those authorities, upon request,

and

• (i) further to a reasoned request from a competent authority in respect of a component which the importer has made available on the market—

• (i) provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the safety component, in a language which can be easily understood by that authority, and

• (ii) cooperate with that authority, at its request, on any action taken to eliminate the risks posed by the safety component which the importer has placed on the market.

Obligations of distributors

• (a) act with due care in relation to the requirements of the Directive or these Regulations when making a safety component available on the market,

• (b) before making the safety component available on the market, verify that—

• (i) the component bears the CE marking,

• (ii) the component is accompanied by the EU declaration of conformity and by the required documents,

• (iii) the component is accompanied by the instructions referred to in point 6.1 of Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations, in a language which can be easily understood by end-users, and

• (iv) the manufacturer and the importer have complied with the requirements set out in Regulation 9(g) and (h), and Regulation 11(2)(c), respectively,

• (c) in a case where the distributor considers or has reason to believe that a safety component is not in conformity with Regulation 6(2)—

• (i) not make the component available on the market until it has been brought into conformity, and

• (ii) where the component presents a risk, inform the manufacturer or the importer to that effect as well as the competent authorities of the Member States,

• (d) ensure that, while the safety component is under the distributor’s responsibility, its storage or transport conditions do not jeopardise its compliance with Regulation 6(2),

• (e) in a case where the distributor considers, or has reason to believe, that a safety component which the distributor has made available on the market is not in conformity with the Directive or these Regulations—

• (i) make sure that the corrective measures necessary to bring that safety component into conformity, to withdraw it or recall it, if appropriate, are taken, and

• (ii) where the safety component presents a risk, immediately inform the competent authorities of the Member States in which the distributor made that component available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken,

and

• (f) further to a reasoned request from a competent authority in respect of a component which the distributor has made available on the market—

• (i) provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the safety component, and

• (ii) cooperate with that authority, at its request, on any action taken to eliminate the risks posed by the safety component.

Cases in which obligations of manufacturers apply to importers and distributors

• (a) places a safety component on the market under the importer or distributor’s name or trade mark, or

• (b) modifies a safety component already placed on the market in such a way that compliance with the Directive or these Regulations may be affected.

Identification of economic operators

• (a) on request, identify to a competent authority any economic operator—

• (i) who has supplied the first named economic operator with a safety component, or

• (ii) to whom the first named economic operator has supplied a safety component, and

• (b) be able to present the information referred to in paragraph (a) for 10 years after the first named economic operator has been supplied with, or who has supplied, the safety component.

PART 3 CONFORMITY OF PRODUCTS

Presumption of conformity on the basis of harmonised standards

Conformity assessment procedures for safety components

• (a) the model of the safety component shall be submitted for EU type examination set out in Annex IV Part A to the Directive, the text of which is set out in Schedule 4 to these Regulations and the conformity to type shall be ensured with random checking of the safety component set out in Annex IX to the Directive, the text of which is set out in Schedule 9 to these Regulations;

• (b) the model of the safety component shall be submitted for EU type examination set out in Annex IV Part A to the Directive, the text of which is set out in Schedule 4 to these Regulations and be subject to conformity to type based on product quality assurance in accordance with Annex VI to the Directive, the text of which is set out in Schedule 6 to these Regulations; or

• (c) conformity based on full quality assurance set out in Annex VII to the Directive, the text of which is set out in Schedule 7 to these Regulations.

Conformity assessment procedures for lifts

• (a) if they are designed and manufactured in accordance with a model lift that has undergone an EU-type examination set out in in Annex IV Part B to the Directive, the text of which is set out in Schedule 4 to these Regulations, the lifts shall be subject to—

• (i) final inspection for lifts set out in Annex V to the Directive, the text of which is set out in Schedule 5 to these Regulations,

• (ii) conformity to type based on product quality assurance for lifts set out in Annex X to the Directive, the text of which is set out in Schedule 10 to these Regulations, or

• (iii) conformity to type based on production quality assurance for lifts set out in Annex XII to the Directive, the text of which is set out in Schedule 12 to these Regulations;

• (b) if they are designed and manufactured under a quality system approved in accordance with Annex XI to the Directive, the text of which is set out in Schedule 11 to these Regulations, the lifts shall be subject to—

• (i) final inspection for lifts set out in Annex V to the Directive, the text of which is set out in Schedule 5 to these Regulations,

• (ii) conformity to type based on product quality assurance for lifts set out in Annex X to the Directive, the text of which is set out in Schedule 10 to these Regulations, or

• (iii) conformity to type based on production quality assurance for lifts set out in Annex XII to the Directive, the text of which is set out in Schedule 12 to these Regulations;

• (c) conformity based on unit verification for lifts set out in Annex VIII to the Directive, the text of which is set out in Schedule 8 to these Regulations; or

• (d) conformity based on full quality assurance plus design examination for lifts set out in Annex XI to the Directive, the text of which is set out in Schedule 11 to these Regulations.

• (2) In the cases referred to in paragraphs 1(a) and (b), where the person responsible for the design and manufacture of the lift and the person responsible for the installation and testing of the lift are not the same, the former shall supply to the latter all the necessary documents and information to enable the latter to ensure correct and safe installation and testing of the lift.

• (3) All permitted variations between the model lift and the lifts forming part of the lifts derived from the model lift shall be clearly specified (with maximum and minimum values) in the technical documentation.

• (4) By calculation or on the basis of design plans it is permitted to demonstrate the similarity of a range of equipment to satisfy the essential health and safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations.

EU declaration of conformity

• (a) state that the fulfilment of the essential health and safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations, has been demonstrated,

• (b) have the model structure set out in Annex II to the Directive, the text of which is set out in Schedule 2 to these Regulations,

• (c) contain the elements specified in the relevant Annexes V to XII to the Directive, the texts of which are set out in Schedules 5 to 12 of these Regulations,

• (d) be continuously updated, and

• (e) be translated into the language or the languages required by the Member State in which the lift or the safety component is placed or made available on the market.

• (2) Where a product is subject to more than one European Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such European Union acts and that declaration shall contain the identification of the European Union acts concerned including their publication references.

• (3) By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the safety component and the installer shall assume responsibility for the compliance of the lift with the requirements laid down in the Directive or these Regulations.

General principles of the CE marking

Rules and conditions for affixing the CE marking and other markings

• (2) Where it is not possible to affix the CE marking to a safety component, before the component is placed on the market, the CE marking shall be affixed to a label inseparably attached to the component.

• (3) The CE marking on lifts shall be followed by the identification number of the notified body involved in any of the following conformity assessment procedures:

• (a) the final inspection referred to in Annex V to the Directive, the text of which is set out in Schedule 5 to these Regulations;

• (b) unit verification, referred to in Annex VIII to the Directive, the text of which is set out in Schedule 8 to these Regulations; or

• (c) quality assurance referred to in Annexes X, XI or XII to the Directive, the texts of which are set out in Schedules 10, 11 and 12 of these Regulations.

• (4) The CE marking on safety components shall be followed by the identification number of the notified body involved in any of the following conformity assessment procedures:

• (a) product quality assurance referred to in Annex VI to the Directive, the text of which is set out in Schedule 6 to these Regulations;

• (b) full quality assurance referred to in Annex VII to the Directive, the text of which is set out in Schedule 7 to these Regulations; or

• (c) conformity to type with random checking for safety components referred to in Annex IX to the Directive, the text of which is set out in Schedule 9 to these Regulations.

• (5) The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or its authorised representative or by the installer or its authorised representative.

• (6) The CE marking and the identification number of the notified body may be followed by any other mark indicating a special risk or use.

PART 4 NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Notified bodies

• (2) Only conformity assessment bodies which have been notified to the European Commission and other Member States in accordance with the Directive and these Regulations and against whom no objections are raised by the European Commission or other Member States within the time periods set down under Article 28(5) of the Directive, shall be notified bodies for the purposes of the Directive and these Regulations.

Application for notification by conformity assessment bodies

• (2) Without prejudice to paragraph (1), where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal, it shall be presumed to comply with the requirements set down in Article 24 of the Directive insofar as the applicable harmonised standards cover those requirements.

• (3) A conformity assessment body seeking to become a notified body shall submit to the notifying authority an application, which application shall be in accordance with Article 27 of the Directive and shall be accompanied by the appropriate fee as may be prescribed by the notifying authority.

Notification of conformity assessment bodies

• (a) has made an application to it in accordance with Article 27 of the Directive, and

• (b) meets the requirements set out in Article 24 of the Directive.

• (2) Notifications by the notifying authority under paragraph (1) shall be made in accordance with the notification procedure set down in Article 28(2), (3) and (4) of the Directive.

• (3) The notifying authority shall notify the European Commission and the other Member States of any subsequent relevant changes to the notification.

• (4) The assessment and monitoring referred to in Article 21(1) and (2) of the Directive shall be carried out by the Irish National Accreditation Board within the meaning of and in accordance with Regulation (EC) No. 765/2008.

Changes to notifications

• (2) In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying authority shall immediately inform the European Commission and the other Member States of the restriction, suspension or withdrawal.

• (3) In the event of restriction, suspension or withdrawal of notification or where the notified body has ceased its activity, the notifying authority shall take appropriate steps to ensure that the files of that notified body are either processed by another notified body or kept available for the responsible notifying and competent authorities at their request.

• (4) The notifying authority shall inform the notified body concerned of its decision and allow that body an opportunity to make representations to it.

• (5) The notifying authority shall establish one panel per appeal (“appeal panel”) for the purposes of considering appeals under this Regulation. An appeal panel shall consist of at least 3 but not more than 5 persons appointed by the notifying authority, one of whom shall be designated by the notifying authority to be chairperson of the panel. An appeal panel shall not consist of any person who decided or was involved in the decision to restrict, suspend or withdraw the relevant notification pertaining to a notified body. An appeal panel shall establish its own procedure.

• (6) Where the notifying authority decides to restrict, suspend or withdraw notification pertaining to a notified body, the latter may, within 14 days of the notification under paragraph (4), appeal to an appeal panel against the restriction, suspension or withdrawal, as the case may be. The notification pertaining to a notified body stands restricted, suspended or withdrawn, as the case may be, from the date of the notification of the decision under paragraph (4), unless the appeal panel, upon an application to it, decides otherwise, pending the outcome of the appeal. On hearing the appeal the appeal panel may confirm the decision, vary it or allow the appeal and shall notify the appellant of its decision. The decision of the appeal panel is final except that an appeal lies to the High Court on application to it on a specified point of law. Such an application does not affect the decision of the appeal panel and its operation.

• (7) All expenses reasonably incurred by the notifying authority in relation to an appeal before an appeal panel or the High Court shall be borne by the appellant where the appeal panel or the court confirms or confirms with a variation the decisions of the notifying authority. The notifying authority may recover these expenses as a simple contract debt in a court of competent jurisdiction.

Subsidiaries of and subcontracting by notified bodies

Operational obligations of notified bodies

• (a) carry out conformity assessments in accordance with the conformity assessment procedures provided for in Articles 15 and 16 of the Directive as set out in Regulations 16 and 17 of these Regulations,

• (b) ensure that conformity assessments are carried out in a proportionate manner, avoiding unnecessary burdens for economic operators,

• (c) perform its activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of lift or safety component technology in question and the mass or serial nature of the production process,

• (d) in a case where it finds that the essential health and safety requirements of the Directive or these Regulations or corresponding harmonised standards or other technical specifications have not been met by an installer or a manufacturer, require that installer or manufacturer to take appropriate corrective measures and shall not issue a certificate or an approval decision,

• (e) in a case where, in the course of the monitoring of conformity following the issue of a certificate or an approval decision, as appropriate, the notified body finds that a lift or a safety component no longer complies, require the installer or the manufacturer to take appropriate corrective measures and suspend or withdraw the certificate or the approval decision if necessary,

• (f) in a case where corrective measures under paragraph (e) are not taken by the manufacturer or the installer or do not have the required effect, restrict, suspend or withdraw any certificates or approval decision(s), as appropriate,

• (g) inform the manufacturer or installer in question where a decision to restrict, suspend or withdraw any certificate or approval decision is taken under paragraph (f), and

• (h) participate in the sectoral group of notified bodies established in accordance with Article 36 of the Directive.

• (2) In carrying out its functions under paragraphs 1(b) and 1(c) of this Regulation, a notified body shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the lifts or the safety components with the Directive or these Regulations.

Appeals against decisions of notified bodies

• (2) An appeal panel shall consist of at least 3 but not more than 5 persons appointed by the notifying authority, one of whom shall be designated by the notifying authority to be chairperson of the panel. An appeal panel shall not consist of any person who decided or was involved in the decision to restrict, suspend or withdraw the relevant certificate or approval decision. An appeal panel shall establish its own procedure.

• (3) Where a notified body decides to restrict, suspend or withdraw a certificate held by a manufacturer or installer, the latter may, within 14 days of the notification of a decision under Regulation 26(g), appeal to an appeal panel against the restriction, suspension or withdrawal, as the case may be. The certificate or approval decision stands restricted, suspended or withdrawn, as the case may be, from the date of notification of the decision under Regulation 26(g), unless the appeal panel, upon an application to it, decides otherwise, pending the outcome of the appeal. On hearing the appeal the appeal panel may confirm the decision, vary it or allow the appeal and shall notify the appellant of its decision. The decision of the appeal panel is final except that an appeal lies to the High Court on application to it on a specified point of law. Such an application does not affect the decision of the appeal panel and its operation.

Information obligation on notified bodies

• (a) inform the notifying authority of the matters referred to in Article 34(1)(a), (b), (c) and (d) of the Directive,

• (b) provide the other bodies notified under the Directive or these Regulations carrying out similar conformity assessment activities covering the same type of lifts or the same safety components with relevant information on issues relating to negative conformity assessment results, and

• (c) on request, provide other bodies notified under the Directive or these Regulations carrying out similar conformity assessment activities covering the same type of lifts or the same safety components with relevant information on issues relating to positive conformity assessment results.

PART 5 MARKET SURVEILLANCE, SAFEGUARD PROCEDURE

Market surveillance

Procedure for dealing with products presenting a risk at national level

• (2) The relevant economic operator shall cooperate as necessary with the market surveillance authority as deemed necessary by it in carrying out an evaluation under paragraph (1).

• (3) Where, in the course of the evaluation referred to in paragraph (1), the market surveillance authority finds that a lift does not comply with the requirements laid down in the Directive or these Regulations, it shall—

• (a) without delay require the installer to take all appropriate corrective actions to bring the lift into compliance with those requirements within a reasonable period commensurate with the nature of the risk, as the authority prescribes,

• (b) inform the notified body who carried out the conformity assessment procedure on the lift of the lift’s non-compliance, and

• (c) apply the provisions of Article 21 of Regulation (EC) No. 765/2008 to the measures referred to in paragraph 3(a) of this Regulation.

• (4) Where, in the course of the evaluation referred to in paragraph (1), the market surveillance authority finds that a safety component does not comply with the requirements laid down in the Directive or these Regulations, it shall—

• (a) without delay require the relevant economic operator to take all appropriate corrective actions to bring the safety component into compliance with those requirements, to withdraw the safety component from the market or to recall it within a reasonable period commensurate with the nature of the risk, as the authority prescribes,

• (b) inform the notified body who carried out the conformity assessment procedure on the safety component of the component’s non-compliance, and

• (c) apply the provisions of Article 21 of Regulation (EC) No 765/2008 to the measures referred to in subparagraph (a).

• (5) Where the market surveillance authority considers that non-compliance is not restricted to the State, it shall inform the European Commission and the other Member States of the results of the evaluation and of the actions which it has required the economic operators to take.

• (6) The relevant economic operator shall ensure that all appropriate corrective action is taken in respect of all the lifts and safety components concerned that it has placed or made available on the market throughout the European Economic Area.

• (7) Where an installer does not take adequate corrective action within the period referred to in paragraph (3)(a) of this Regulation, the market surveillance authority shall, without delay, take all appropriate provisional measures to restrict or prohibit the lift from being placed on the market in the State, or the use of the lift concerned or to recall it.

• (8) Where the relevant economic operator does not take adequate corrective action within the period referred to in paragraph 4(a) of this Regulation, the market surveillance authority shall, without delay, take all appropriate provisional measures to prohibit or restrict the safety component from being made available on the market in the State, to withdraw the safety component from the market or to recall it.

• (9) The market surveillance authority shall inform the European Commission and the other Member States, without delay, of any measures taken under paragraphs (7) or (8) of this Regulation, and shall—

• (a) include all available details, in particular the data necessary for the identification of the non-compliant lift or safety component, the origin of the lift or safety component, the nature of the non-compliance alleged and the risk involved, the nature and duration of the measures taken in the State and the arguments put forward by the relevant economic operators, and

• (b) in particular, indicate whether the non-compliance is due to either—

• (i) the failure of the lift or the safety component to meet requirements relating to the essential health and safety requirements of the Directive or these Regulations, or

• (ii) shortcomings in the harmonised standards referred to in Regulation 15 conferring a presumption of conformity.

• (10) Where another Member State has initiated the procedure under Article 38 of the Directive, the market surveillance authority shall, without delay, inform the European Commission and the other Member States—

• (a) of any measures adopted and of any additional information at its disposal relating to the non-compliance of the lift or the safety component concerned, or

• (b) of its objections, in the event of disagreement with the adopted measure of the other Member State.

• (11) Where, within three months of receipt of the information referred to in paragraph (9) of this Regulation, no objection has been raised by either a Member State or the European Commission in respect of a provisional measure taken by the market surveillance authority, that measure shall be deemed to be justified.

• (12) The market surveillance authority shall ensure that appropriate restrictive measures, such as withdrawal of a safety component from the market, are taken in respect of the lift or the safety component concerned without delay.

Safeguard procedure

• (a) in the case of a measure relating to a lift, take the measures necessary to ensure that the placing on the market or use of the non-compliant lift is restricted or prohibited, or that the lift is recalled and inform the European Commission accordingly, or

• (b) in the case of a measure relating to a safety component, take the necessary measures to ensure that the non-compliant safety component is withdrawn from the market in the State and inform the European Commission accordingly.

• (2) Where a measure proposed by the market surveillance authority is considered unjustified by the European Commission in accordance with the procedure in Article 39(1) of the Directive, the market surveillance authority shall withdraw that measure.

Compliant lifts or safety components which present a risk

• (a) in the case of a lift, require the installer to take all appropriate measures to ensure that the lift concerned, when placed on the market, no longer presents that risk, to recall the lift or restrict or prohibit its use within a reasonable period, commensurate with the nature of the risk, as it may prescribe,

• (b) in the case of a safety component, require the relevant economic operator to take all appropriate measures to ensure that the safety component concerned, when placed on the market, no longer presents that risk, to withdraw the safety component from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe,

• (c) immediately inform the European Commission and the other Member States, of all available details and in particular of—

• (i) the data necessary for the identification of the lifts or safety components concerned,

• (ii) the origin and the supply chain of the lifts or safety components,

• (iii) the nature of the risk involved, and

• (iv) the nature and the duration of the national measures taken.

• (2) An economic operator shall ensure that the corrective action required under paragraph (1) is taken in respect of all the lifts or safety components that the economic operator has placed or made available on the market throughout the European Economic Area.

Formal non-compliance

• (a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No. 765/2008 or of Article 19 of the Directive or Regulation 20 of these Regulations,

• (b) the CE marking has not been affixed,

• (c) the identification number of the notified body has been affixed in violation of Article 19 of the Directive or Regulation 20 of these Regulations or has not been affixed where required by that Article or Regulation,

• (d) the EU declaration of conformity has not been drawn up,

• (e) the EU declaration of conformity has not been drawn up correctly,

• (f) the technical documentation referred to in Annex IV, Parts A and B, Annexes VII, VIII and XI to the Directive, the texts of which are set out in Schedules 4, 7, 8 and 11 to these Regulations, is either not available or not complete,

• (g) the name, registered trade name or registered trade mark or the address of the installer, manufacturer, or importer has not been indicated in compliance with Article 7(6), 8(6) or 10(3) of the Directive or Regulation 8(g), 9(h) or 11(2)(c) of these Regulations,

• (h) the information allowing identification of the lift or safety component has not been indicated in compliance with Article 7(5) or 8(5) of the Directive or Regulation 8(f) or 9(g) of these Regulations, or

• (i) a lift or safety component is not accompanied by the documents referred to in Article 7(7) or 8(7) of the Directive or Regulation 8(h) or 9(i) of these Regulations or those documents are not in compliance with the applicable requirements.

• (2) Where the non-compliance referred to in paragraph (1) persists, the market surveillance authority shall take all appropriate measures to restrict or prohibit the use of the lift or to recall it or to restrict or prohibit the making available on the market of the safety component or shall ensure that the component is recalled or withdrawn from the market.

PART 6 POWERS OF THE MARKET SURVEILLANCE AUTHORITY

General

• (2) A person who for the time being stands appointed as an inspector under section 62 of the Act of 2005 shall be an inspector for the purpose of the Directive and these Regulations.

• (3) An inspector shall, when exercising any power conferred on him or her by these Regulations, if requested to do so by any person affected, produce the certificate of authorisation, or a copy of it, furnished to him or her under section 62(2) of the Act of 2005 together with a form of personal identification.

Powers of inspectors

• (a) subject to paragraph (4), at any time enter—

• (i) the premises of an economic operator,

• (ii) the premises where a product is installed, or

• (iii) any other place or premises where entry on same is necessary to ensure that the objectives of the Directive are achieved;

• (b) inquire into, search, examine and inspect—

• (i) any place referred to in paragraph 1(a),

• (ii) any activity, installation, process, procedure, matter or thing at or in that place, and

• (iii) any product or any record relating to such product, to ascertain whether the the Directive or these Regulations have been or are being complied with and, for that purpose, take with him or her and use any equipment or materials he or she considers necessary;

• (c) require that that place and anything at or in it be left undisturbed for so long as is reasonably necessary for the purposes of any search, examination, investigation, inspection or inquiry under the Directive or these Regulations;

• (d) require the person in charge to produce to the inspector—

• (i) any product or partly completed product which is in the possession or under the control of such person, and

• (ii) any records, and in the case of such information in a non-legible form, to reproduce it in a legible form, and to give to the inspector such information as the inspector may reasonably require in relation to any entries in those records;

• (e) inspect and take copies of or extracts from any such records or any electronic information system at that place, including in the case of information in a non-legible form, copies of or extracts from such information in a permanent legible form or require that such copies be provided;

• (f) require a person at or in that place by whom or on whose behalf a computer is or has been used to produce or store records or any person having control of, or otherwise concerned with the operation of the computer, to afford the inspector access thereto and all reasonable assistance as the inspector may require;

• (g) remove from that place and retain the records (including documents stored in a non-legible form) and copies taken and retain the records for such period as the inspector reasonably considers to be necessary for further examination or until the conclusion of any legal proceedings;

• (h) require that records at or in that place be maintained for such period as may be reasonable;

• (i) require the person in charge to give the inspector such information as the inspector may reasonably require for the purposes of any search, examination, investigation, inspection or inquiry under these Regulations;

• (j) require the person in charge to give the inspector such assistance and facilities within the person’s power or control as are reasonably necessary to enable the inspector to exercise any of his or her powers under these Regulations;

• (k) require by notice, at a time and place specified in the notice, any person (including the person in charge) to give the inspector any information that the inspector may reasonably require in relation to the place, any product, equipment, item, activity, installation or procedure at or in the place, and to produce to the inspector any records that are under that person’s power or control;

• (l) examine any person whom the inspector reasonably believes to be able to give to the inspector information relevant to any search, examination, investigation, inspection or inquiry under these Regulations and require the person to answer such questions as the inspector may ask relative to the search, examination, investigation, inspection or inquiry and to sign a declaration of the truth of the answers;

• (m) require that any procedure be followed for the purposes of any search, examination, investigation, inspection or inquiry under these Regulations;

• (n) take any measurements or photographs or make any tape, electrical or other recordings that the inspector considers necessary for the purposes of any search, examination, investigation, inspection or inquiry under these Regulations;

• (o) take samples of air, soil, water or waste at or near that place;