Article 1: Scope
Article 2: Definitions
Article 3: Making available on the market and putting into service
Article 4: Gas supply conditions
Article 5: Essential requirements
Article 6: Free movement
Article 7: Obligations of manufacturers
Where compliance of an appliance or a fitting with the applicable requirements has been demonstrated by the procedure referred to in the first subparagraph, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.
When deemed appropriate with regard to the risks presented by an appliance, manufacturers shall, to protect the health and safety of consumers and other users, carry out sample testing of appliances made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming appliances and fittings and recalls of such appliances and fittings, and shall keep distributors informed of any such monitoring.
Where the size or nature of the appliance or the fitting does not allow it, manufacturers shall ensure that the required information is provided on the packaging or in a document accompanying the appliance or the fitting.
Manufacturers shall indicate on the fitting their name, registered trade name or registered trade mark, and the postal address at which they can be contacted or, where that is not possible, on the packaging or in a document accompanying the fitting. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by appliance manufacturers and the market surveillance authorities.
Manufacturers shall ensure that the fitting is accompanied by a copy of the EU declaration of conformity containing, inter alia, instructions for incorporation or assembly, adjustment, operation and maintenance in accordance with point 1.7 of Annex I, in a language which can be easily understood by appliance manufacturers, as determined by the Member State concerned.
However, where a large number of fittings are delivered to a single user, the batch or consignment concerned may be accompanied by a single copy of the EU declaration of conformity.
Article 8: Authorised representatives
The obligations laid down in Article 7(1) and the obligation to draw up technical documentation shall not form part of the authorised representative's mandate.
Article 9: Obligations of importers
Before placing a fitting on the market, importers shall ensure that the appropriate conformity assessment procedure referred to in Article 14 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the fitting bears the CE marking and is accompanied by a copy of the EU declaration of conformity containing, inter alia, instructions for incorporation or assembly, adjustment, operation and maintenance in accordance with point 1.7 of Annex I, and that the manufacturer has complied with the requirements set out in Article 7(5) and (6).
Where an importer considers or has reason to believe that an appliance or a fitting is not in conformity with the essential requirements set out in Annex I, he shall not place the appliance or the fitting on the market until it has been brought into conformity. Furthermore, where the appliance or the fitting presents a risk, the importer shall inform the manufacturer and the market surveillance authorities to that effect.
Importers shall indicate on the fitting their name, registered trade name or registered trade mark, and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the fitting. The contact details shall be in a language easily understood by appliance manufacturers and the market surveillance authorities.
Importers shall ensure that the fitting is accompanied by a copy of the EU declaration of conformity containing, inter alia, instructions for incorporation or assembly, adjustment, operation and maintenance in accordance with point 1.7 of Annex I, in a language which can be easily understood by appliance manufacturers, as determined by the Member State concerned.
Article 10: Obligations of distributors
Before making a fitting available on the market, distributors shall verify that the fitting bears the CE marking and that it is accompanied by a copy of the EU declaration of conformity containing, inter alia, instructions for incorporation or assembly, adjustment, operation and maintenance in accordance with point 1.7 of Annex I, in a language which can be easily understood by appliance manufacturers, as determined by the Member State concerned, and that the manufacturer and the importer have complied with the requirements set out in Article 7(5) and (6) and Article 9(3) respectively.
Where a distributor considers or has reason to believe that an appliance or a fitting is not in conformity with the essential requirements set out in Annex I, he shall not make the appliance or the fitting available on the market until it has been brought into conformity. Furthermore, where the appliance or the fitting presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities.
Article 11: Cases in which obligations of manufacturers apply to importers and distributors
Article 12: Identification of economic operators
Article 13: Presumption of conformity of appliances and fittings
Article 14: Conformity assessment procedures for appliances and fittings
Article 15: EU declaration of conformity
Article 16: General principles of the CE marking
Article 17: Rules and conditions for affixing the CE marking
Article 18: Inscriptions
Article 19: Notification
Article 20: Notifying authorities
Article 21: Requirements relating to notifying authorities
Article 22: Information obligation on notifying authorities
The Commission shall make that information publicly available.
Article 23: Requirements relating to notified bodies
A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of appliances or fittings which it assesses, may, on the condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those appliances or fittings, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.
Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.
At all times, and for each conformity assessment procedure and each kind or category of appliances or fittings in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:
The remuneration of the top level management and of the personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.
Article 24: Presumption of conformity of notified bodies
Article 25: Subsidiaries of and subcontracting by notified bodies
Article 26: Application for notification
Article 27: Notification procedure
Only such a body shall be considered a notified body for the purposes of this Regulation.
Article 28: Identification numbers and lists of notified bodies
It shall assign a single such number even where the body is notified under several Union acts.
The Commission shall ensure that the list is kept up to date.
Article 29: Changes to notifications
Article 30: Challenge of the competence of notified bodies
That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 42(2).
Article 31: Operational obligations of notified bodies
Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the appliance or fitting technology in question and the mass or serial nature of the production process.
In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the appliance or the fitting with this Regulation.
Article 32: Appeal against decisions of notified bodies
Article 33: Information obligation on notified bodies
Article 34: Exchange of experience
Article 35: Coordination of notified bodies
Notified bodies shall participate in the work of that group or those groups, directly or by means of designated representatives.
Article 36: Union market surveillance and control of appliances and fittings entering the Union market
Article 37: Procedure at national level for dealing with appliances or fittings presenting a risk
Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the appliance or fitting does not comply with the requirements laid down in this Regulation, they shall without delay require the relevant economic operator to take all appropriate corrective action to bring the appliance or fitting into compliance with those requirements, to withdraw the appliance or fitting from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe.
The market surveillance authorities shall inform the relevant notified body accordingly.
Article 21 of Regulation 2008/765 shall apply to the measures referred to in the second subparagraph of this paragraph.
The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.
Article 38: Union safeguard procedure
The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.
Article 39: Compliant appliances or fittings which present a risk
The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 42(3).
On duly justified imperative grounds of urgency relating to the protection of health and safety of persons, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 42(4).
Article 40: Formal non-compliance
Article 41: Exercise of the delegation
It is of particular importance that the Commission follow its usual practice and carry out consultations with experts, including Member States' experts, before adopting those delegated acts.
Article 42: Committee procedure
The committee may furthermore examine any other matter concerning the application of this Regulation raised either by its chair or by a representative of a Member State in accordance with its rules of procedure.
Article 43: Penalties
The penalties provided for shall be effective, proportionate and dissuasive.
Member States shall notify those rules to the Commission by 21 March 2018 and shall notify it without delay of any subsequent amendment affecting them.
Article 44: Transitional provisions
Article 45: Repeal
References to the repealed Directive shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VI.
Article 46: Entry into force and application
Recital 1
Recital 2
Recital 3
Recital 4
Recital 5
Recital 6
Recital 7
Recital 8
Recital 9
Recital 10
Recital 11
Recital 12
Recital 13
Recital 14
Recital 15
Recital 16
Recital 17
Recital 18
Recital 19
Recital 20
Recital 21
Recital 22
Recital 23
Recital 24
Recital 25
Recital 26
Recital 27
Recital 28
Recital 29
Recital 30
Recital 31
Recital 32
Recital 33
Recital 34
Recital 35
Recital 36
Recital 37
Recital 38
Recital 39
Recital 40
Recital 41
Recital 42
Recital 43
Recital 44
Recital 45
Recital 46
Recital 47
Recital 48
Recital 49
Recital 50
Recital 51
Recital 52
Recital 53
Recital 54
Recital 55
Recital 56
Recital 57
Recital 58
Recital 59
Recital 60
Recital 61
Recital 62
Recital 63
Recital 64
Recital 65
Recital 66
Recital 67
Recital 68
Recital 69
Recital 70
Recital 71
Recital 72
Recital 73
Recital 74
Recital 75
Recital 76
Recital 77
Recital 78
Recital 79
ESSENTIAL REQUIREMENTS ESSENTIAL REQUIREMENTS
PRELIMINARY OBSERVATIONS:
The essential requirements laid down in this Regulation are compulsory.
The essential requirements are to be interpreted and applied in such a way as to take into account the state of the art and current practice at the time of design and manufacture as well as technical and economic considerations which are consistent with a high degree of energy efficiency and of health and safety protection.
GENERAL REQUIREMENTS
1. Appliances shall be so designed and constructed as to operate safely and present no danger to persons, domestic animals or property, when normally used.
Fittings shall be so designed and constructed as to fulfil correctly their intended purpose when incorporated into an appliance or assembled to constitute an appliance.
2. The manufacturer is under an obligation to analyse the risks in order to identify those which apply to his appliance or fitting. He shall then design and construct it taking into account its risk assessment.
3. In selecting the most appropriate solutions, the manufacturer shall apply the principles set out below, in the following order:
5. All appliances shall:
The instructions for installation intended for the installer shall include also information on the technical specifications of the interface between the appliance and its installation environment allowing its correct connection to the gas supply network, the supply of auxiliary energy, the combustion air supply and the flue gas evacuation system.
6.2. The instructions for use and servicing intended for the user shall contain all the information required for safe use and in particular shall draw the user's attention to any restrictions on use.
The manufacturers shall note in the instructions where additional care is needed or where it would be advisable that any of the above work be carried out by a professional. This shall be without prejudice to national requirements to that effect.
The manufacturer of the appliance shall include in the instructions accompanying the appliance all necessary information for adjustment, operation and maintenance of the fittings as part of the finished appliance, as appropriate.
6.3. The warning notices on the appliance and its packaging shall clearly state the type of gas to be used, the gas supply pressure, the appliance category and any restrictions on use, in particular the restriction whereby the appliance shall be installed only in areas where there is sufficient ventilation so as to ensure that the risks presented by it are minimised.
7. The instructions for incorporation of the fitting into an appliance or its assembly in order to constitute an appliance and for its adjustment, operation and maintenance shall be provided with the fittings concerned as part of the EU declaration of conformity.
MATERIALS
Materials for appliances or fittings shall be appropriate for their intended purpose and shall withstand the mechanical, chemical and thermal conditions to which they will foreseeably be subjected.
DESIGN AND CONSTRUCTION
The obligations arising for appliances from the essential requirements set out in this point apply also to fittings, as far as relevant.
1. General
1.1. Appliances shall be so designed and constructed that, when normally used, no instability, distortion, breakage or wear likely to impair their safety may occur.
1.2. Condensation produced at the start-up and/or during use shall not affect the safety of appliances.
1.3. Appliances shall be so designed and constructed as to minimise the risk of explosion in the event of a fire of external origin.
1.4. Appliances shall be so designed and constructed that water and inappropriate air penetration into the gas circuit does not occur.
1.5. In the event of a normal fluctuation of auxiliary energy, appliances shall continue to operate safely.
1.6. Abnormal fluctuation or failure of auxiliary energy or its restoration shall not lead to an unsafe situation.
1.7. Appliances shall be so designed and constructed as to obviate any gas-related risks due to hazards of electrical origin. As far as relevant, the results of the conformity assessment in relation to the safety requirements of Directive 2014/53/EU of the European Parliament and of the Council ( 1 ) or the safety objectives of Directive 2014/35/EU of the European Parliament and of the Council ( 2 ) shall be taken into account.
1.8. Appliances shall be so designed and constructed as to obviate any gas-related risks due to hazards originating from electromagnetic phenomena. As far as relevant, the results of the conformity assessment in relation to the electromagnetic compatibility requirements of Directive 2014/53/EU or Directive 2014/30/EU of the European Parliament and of the Council ( 3 ) shall be taken into account.
1.9. All pressurised parts of an appliance shall withstand the mechanical and thermal stresses to which they are subjected without any deformation affecting safety.
1.10. Appliances shall be so designed and constructed that failure of a safety, controlling or regulating device may not lead to an unsafe situation.
1.11. If an appliance is equipped with safety and controlling devices, the functioning of the safety devices shall not be overruled by that of the controlling devices.
1.12. All parts of appliances which are set or adjusted at the stage of manufacture and which should not be manipulated by the user or the installer shall be appropriately protected.
1.13. Levers and other controlling and setting devices shall be clearly marked and give appropriate instructions so as to prevent any error in operation/use. Their design shall be such as to preclude accidental operation.
2. Unburned gas release
2.1. Appliances shall be so designed and constructed that the gas leakage rate is not dangerous.
2.2. Appliances shall be so designed and constructed that gas release at any state of operation is limited in order to avoid a dangerous accumulation of unburned gas in the appliance.
2.3. Appliances intended to be used in indoor spaces and rooms shall be so designed and constructed as to prevent the release of unburned gas in all situations which could lead to a dangerous accumulation of unburned gas in such spaces and rooms.
2.4. Appliances designed and constructed to burn gas containing carbon monoxide or other toxic components shall not present a danger to the health of persons and domestic animals exposed.
3. Ignition
Appliances shall be so designed and constructed that, when normally used, ignition and re-ignition is smooth and cross-lighting is assured.
4. Combustion
4.1. Appliances shall be so designed and constructed that, when normally used, the combustion process is stable and combustion products do not contain unacceptable concentrations of substances harmful to health.
4.2. Appliances shall be so designed and constructed that, when normally used, there will be no accidental release of combustion products.
4.3. Appliances connected to a flue for the dispersal of combustion products shall be so designed and constructed that in abnormal draught conditions there is no release of combustion products in a dangerous quantity into the indoor spaces or rooms concerned.
4.4. Appliances shall be so designed and constructed that, when normally used, they do not cause a concentration of carbon monoxide or other substances harmful to health, such as they would be likely to present a danger to the health of persons and domestic animals exposed.
5. Rational use of energy
Appliances shall be so designed and constructed as to ensure rational use of energy, reflecting the state of the art and taking into account safety aspects.
6. Temperature
6.1. Parts of appliances which are intended to be installed or placed in close proximity to surfaces shall not reach temperatures which present a danger.
6.2. The surface temperature of parts of appliances intended to be handled during normal use shall not present a danger to the user.
6.3. The surface temperatures of external parts of appliances, with the exception of surfaces or parts which are associated with the transmission of heat, shall not under operating conditions present a danger to the health and safety of persons exposed and in particular to children and elderly people, for whom an appropriate reaction time shall be taken into account.
7. Contact with food and water intended for human consumption
Without prejudice to Regulations Regulation 2004/1935 ( 4 ) and (EU) No 305/2011 ( 5 ) of the European Parliament and of the Council, materials and parts used in the construction of an appliance which may come into contact with food or water intended for human consumption as defined in Article 2 of Council Directive 98/83/EC ( 6 ) , shall not impair quality of the food or water.
( 1 ) Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC ( OJ L 153, 22.5.2014, p. 62 ).
( 2 ) Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits ( OJ L 96, 29.3.2014, p. 357 ).
( 3 ) Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility ( OJ L 96, 29.3.2014, p. 79 ).
( 4 ) Regulation 2004/1935 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC ( OJ L 338, 13.11.2004, p. 4 ).
( 5 ) Regulation 2011/305 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC ( OJ L 88, 4.4.2011, p. 5 ).
( 6 ) Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption ( OJ L 330, 5.12.1998, p. 32 ).
CONTENT OF THE MEMBER STATES COMMUNICATIONS OF THE GAS SUPPLY CONDITIONS CONTENT OF THE MEMBER STATES COMMUNICATIONS OF THE GAS SUPPLY CONDITIONS
CONFORMITY ASSESSMENT PROCEDURES FOR APPLIANCES AND FITTINGS CONFORMITY ASSESSMENT PROCEDURES FOR APPLIANCES AND FITTINGS
MODULE B: EU TYPE-EXAMINATION — PRODUCTION TYPE
1. EU type-examination is the part of a conformity assessment procedure in which a notified body examines the technical design of an appliance or a fitting and verifies and attests that the technical design of the appliance or the fitting meets the requirements of this Regulation that apply to it.
2. EU type-examination shall be carried out by assessment of the adequacy of the technical design of the appliance or the fitting through examination of the technical documentation and supporting evidence referred to in point 1.3, plus examination of a specimen, representative of the production envisaged, of the complete appliance or fitting (production type).
3. The manufacturer shall lodge an application for EU type-examination with a single notified body of his choice.
3.1. The application shall include the following:
For the appliance or the fitting:
6. Where the appliance or the fitting type meets the requirements of this Regulation, the notified body shall issue an EU type-examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity, the necessary data for identification of the approved type, such as the type of gas, appliance category and gas supply pressure, and, if relevant, descriptions of its functioning. The 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 appliances or fittings with the examined type to be evaluated and to allow for in-service control. It shall also indicate any conditions to which its issue may be subject and be accompanied by the descriptions and drawings necessary for identification of the approved type.
The certificate shall have a maximum validity period of ten years from the date of its issue.
Where the type does not satisfy the applicable requirements of this Regulation, the notified body shall refuse to issue an EU type-examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
7. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of this Regulation, 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 appliance or the fitting with the essential requirements of this Regulation or the conditions for validity of the certificate. Such modifications shall require additional approval in the form of an addition to the original EU type-examination certificate.
8. 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.
9. 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 appliance or the fitting has been placed on the market.
The manufacturer's authorised representative may lodge the application referred to in point 1.3 and fulfil the obligations set out in points 1.7 and 1.9, provided that they are specified in the mandate.
MODULE C2: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT CHECKS AT RANDOM INTERVALS
1. Conformity to type based on internal production control plus supervised product checks at random intervals is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2.2, 2.3 and 2.4, and ensures and declares on his sole responsibility that the appliances or the fittings concerned are in conformity with the type described in the EU type-examination certificate and satisfy the requirements of this Regulation that apply to them.
2. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured appliances or fittings with the type described in the EU type-examination certificate and with the requirements of this Regulation that apply to them.
3. Product checks
A notified body, chosen by the manufacturer, shall carry out product checks or have them carried out at intervals of one year or less, in order to verify the quality of the internal checks on the appliance or the fitting, taking into account, inter alia, the technological complexity of the appliances or the fittings and the quantity of production. An adequate sample of the final appliances or fittings taken on site by the notified body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the harmonised standards, and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to check the conformity of the appliance or the fitting with the relevant requirements of this Regulation. Where a sample does not conform to the acceptable quality level, the notified body shall take appropriate measures.
The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the appliance or the fitting performs within acceptable limits, with a view to ensuring conformity of the appliance or the fitting.
The manufacturer shall, under the responsibility of the notified body, affix the notified body's identification number during the manufacturing process.
4. CE marking and EU declaration of conformity
4.1. The manufacturer shall affix the CE marking to each individual appliance or fitting that is in conformity with the type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation.
4.2. The manufacturer shall draw up a written EU declaration of conformity for each appliance or fitting model and keep it at the disposal of the national authorities for 10 years after the appliance or fitting has been placed on the market. The EU declaration of conformity shall identify the appliance or fitting model for which it has been drawn up.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment.
5. Authorised representative
The manufacturer's obligations set out in point 2.4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS
1. Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 3.2 and 3.5, and ensures and declares on his sole responsibility that the appliances or fittings concerned are in conformity with the type described in the EU type-examination certificate and satisfy the requirements of this Regulation that apply to them.
2. Manufacturing
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the appliances or fittings concerned as specified in point 3.3, and shall be subject to surveillance as specified in point 3.4.
3. Quality system
3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the appliances or fittings concerned.
The application shall include:
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 shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
It shall, in particular, contain an adequate description of:
It shall presume conformity with those requirements in respect of the elements of the quality system 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 the product technology concerned, and knowledge of the applicable requirements of this Regulation. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in point 3.3.1(e), to verify the manufacturer's ability to identify the relevant requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the appliance or the fitting 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 maintain it 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 3.3.2 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:
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 and EU declaration of conformity
5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.3.1, the latter's identification number to each individual appliance or fitting that is in conformity with the type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation.
5.2. The manufacturer shall draw up a written EU declaration of conformity for each appliance or fitting model and keep it at the disposal of the national authorities for 10 years after the appliance or the fitting has been placed on the market. The EU declaration of conformity shall identify the appliance or fitting model for which it has been drawn up.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment.
6. The manufacturer shall, for a period ending at least 10 years after the appliance or the fitting has been placed on the market, keep at the disposal of the national authorities:
Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.
8. Authorised representative
The manufacturer's obligations set out in points 3.3.1, 3.3.5, 3.5 and 3.6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
MODULE E: CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE
1. Conformity to type based on product quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 4.2 and 4.5, and ensures and declares on his sole responsibility that the appliances or fittings concerned are in conformity with the type described in the EU type-examination certificate and satisfy the requirements of this Regulation that apply to them.
2. Manufacturing
The manufacturer shall operate an approved quality system for final product inspection and testing of the appliances or fittings concerned as specified in point 4.3 and shall be subject to surveillance as specified in point 4.4.
3. Quality system
3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the appliances or fittings concerned.
The application shall include:
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 shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
It shall, in particular, contain an adequate description of:
It shall presume conformity with those requirements in respect of the elements of the quality system 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 this Regulation. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in point 4.3.1(e), in order to verify the manufacturer's ability to identify the relevant requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the appliance or the fitting 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 maintain it 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 4.3.2 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:
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 and EU declaration of conformity
5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 4.3.1, the latter's identification number to each individual appliance or fitting that is in conformity with the type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation.
5.2. The manufacturer shall draw up a written EU declaration of conformity for each appliance or fitting model and keep it at the disposal of the national authorities for 10 years after the appliance or the fitting has been placed on the market. The EU declaration of conformity shall identify the appliance or fitting model for which it has been drawn up.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment.
6. The manufacturer shall, for a period ending at least 10 years after the appliance or the fitting has been placed on the market, keep at the disposal of the national authorities:
Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.
8. Authorised representative
The manufacturer's obligations set out in points 4.3.1, 4.3.5, 4.5 and 4.6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
MODULE F: CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION
1. Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 5.2, 5.5.1 and 5.6, and ensures and declares on his sole responsibility that the appliances or fittings concerned, which have been subject to point 5.3, are in conformity with the type described in the EU type-examination certificate and satisfy the requirements of this Regulation that apply to them.
2. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured appliances or fittings with the approved type described in the EU type-examination certificate and with the requirements of this Regulation that apply to them.
3. Verification
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, or have them carried out, in order to check the conformity of the appliances or fittings with the approved type described in the EU type-examination certificate and with the appropriate requirements of this Regulation.
The examinations and tests to check the conformity of the appliances or fittings with the appropriate requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every appliance or fitting as specified in point 5.4 or by examination and testing of the appliances or fittings on a statistical basis as specified in point 5.5.
4. Verification of conformity by examination and testing of every appliance or fitting
4.1. All appliances or fittings shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or equivalent tests set out in other relevant technical specifications shall be carried out in order to verify conformity with the approved type described in the EU type-examination certificate and with the appropriate requirements of this Regulation.
In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.
4.2. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved appliance or fitting, or have it affixed under its responsibility.
The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the appliance or the fitting has been placed on the market.
5. Statistical verification of conformity
5.1. The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and shall present his appliances or fittings for verification in the form of homogeneous lots.
5.2. A random sample shall be taken from each lot in accordance with the requirements of point 5.5.3. All appliances or fittings in a sample shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the applicable requirements of this Regulation and to determine whether the lot is accepted or rejected. In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.
5.3. The notified body shall apply a sampling system with the following characteristics:
The notified body shall issue a certificate of conformity in respect to the examinations and tests carried out, and shall affix its identification number to each approved appliance or fitting, or have it affixed under its responsibility.
The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the appliance or the fitting has been placed on the market.
5.5. If a lot is rejected, the notified body or the competent authority shall take appropriate measures to prevent that lot being placed on the market. In the event of the frequent rejection of lots the notified body may suspend the statistical verification and take appropriate measures.
6. CE marking and EU declaration of conformity
6.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 5.3, the latter's identification number to each individual appliance or fitting that is in conformity with the approved type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation.
6.2. The manufacturer shall draw up a written EU declaration of conformity for each appliance or fitting model and keep it at the disposal of the national authorities, for 10 years after the appliance or the fitting has been placed on the market. The EU declaration of conformity shall identify the appliance or fitting model for which it has been drawn up.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment.
If the notified body referred to in point 5.3 agrees and under its responsibility, the manufacturer may also affix the notified body's identification number to the appliance or the fitting.
7. If the notified body agrees and under its responsibility, the manufacturer may affix the notified body's identification number to the appliances or the fittings during the manufacturing process.
8. Authorised representative
The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer's obligations set out in points 5.2 and 5.5.1.
MODULE G: CONFORMITY BASED ON UNIT VERIFICATION
1. Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 6.2, 6.3 and 6.5, and ensures and declares on his sole responsibility that the appliance or the fitting concerned, which has been subject to point 6.4, is in conformity with the requirements of this Regulation that apply to it.
2. Technical documentation
The manufacturer shall establish the technical documentation and make it available to the notified body referred to in point 6.4. The technical documentation shall make it possible to assess the appliance's or fitting's conformity with the applicable requirements of this Regulation, 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 appliance or the fitting.
2.1. The technical documentation shall, wherever applicable, contain at least the following elements:
3. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured appliances or fittings with the applicable requirements of this Regulation.
4. Verification
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised standards and/or equivalent tests set out in other relevant technical specifications, to check the conformity of the appliances or fittings with the applicable requirements of this Regulation, or have them carried out. In the absence of such a harmonised standard the notified body concerned shall decide on the appropriate tests to be carried out.
If deemed necessary by the notified body, the examinations and tests may be carried out after the incorporation of the fitting, the assembly or the installation of the appliance.
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved appliances or fittings, or have it affixed under its responsibility.
The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the appliance or the fitting has been placed on the market.
5. CE marking and EU declaration of conformity
5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 6.4, the latter's identification number to each appliance or fitting that satisfies the applicable requirements of this Regulation.
5.2. The manufacturer shall draw up a written EU declaration of conformity and keep it at the disposal of the national authorities for 10 years after the appliance or the fitting has been placed on the market. The EU declaration of conformity shall identify the appliance or the fitting for which it has been drawn up.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment.
6. Authorised representative
The manufacturer's obligations set out in points 6.2 and 6.5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
INSCRIPTIONS INSCRIPTIONS
EU DECLARATION OF CONFORMITY No … ( 1 ) EU DECLARATION OF CONFORMITY No …
(place and date of issue):
(name, function) (signature):
( 1 ) It is optional for the manufacturer to assign a number to the declaration of conformity.
CORRELATION TABLE CORRELATION TABLE
Footnote p0: This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 9 March 2016.