Regulation (EU) 2016/426 of the European Parliament and of the CouncilShow full title

ANNEX III U.K. CONFORMITY ASSESSMENT PROCEDURES FOR APPLIANCES AND FITTINGS

1. MODULE B: EU TYPE-EXAMINATION — PRODUCTION TYPE U.K.

1.1. 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. U.K.

1.2. 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). U.K.

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

1.3.1. The application shall include the following: U.K.

(a)

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

(b)

a written declaration that the same application has not been lodged with any other notified body;

(c)

the technical documentation. The technical documentation shall make it possible to assess the 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. The technical documentation shall contain, wherever applicable, at least the following elements:

(1)

a general description of the appliance or the fitting;

(2)

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

(3)

descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the appliance or the fitting;

(4)

a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Regulation, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;

(5)

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

(6)

test reports;

(7)

instructions for installation and use of the appliance;

(8)

the EU declaration of conformity of the fitting containing the instructions on how the fitting should be incorporated into an appliance or assembled to constitute an appliance;

(d)

the specimens representative of the production envisaged. The notified body may request further specimens where needed for carrying out the test programme;

(e)

the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

1.3.2. Where appropriate, the manufacturer shall also submit to the notified body the following documents: U.K.

(a)

the EU type-examination certificate and the EU declaration of conformity relating to the fittings incorporated into the appliance;

(b)

attestations and certificates relating to the methods of manufacture and/or inspection and/or monitoring of the appliance or the fitting;

(c)

any other document making it possible for the notified body to improve its assessment.

1.4. The notified body shall: U.K.

For the appliance or the fitting:

1.4.1.

examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the appliance or the fitting.

For the specimen(s):

1.4.2.

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

1.4.3.

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

1.4.4.

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

1.4.5.

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

1.5. The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 1.4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer. U.K.

1.6. 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. U.K.

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.

1.7. 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. U.K.

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.

1.8. 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. U.K.

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.

1.9. 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. U.K.

1.10. 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. U.K.

2. MODULE C2: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT CHECKS AT RANDOM INTERVALS U.K.

2.1. 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. U.K.

2.2. Manufacturing U.K.

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.

2.3. Product checks U.K.

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.

2.4. CE marking and EU declaration of conformity U.K.

2.4.1. 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. U.K.

2.4.2. 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. U.K.

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.

2.5. Authorised representative U.K.

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.

3. MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS U.K.

3.1. 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. U.K.

3.2. Manufacturing U.K.

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.

3.3. Quality system U.K.

3.3.1. 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. U.K.

The application shall include:

(a)

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

(b)

a written declaration that the same application has not been lodged with any other notified body;

(c)

all relevant information for the appliance or the fitting approved under module B;

(d)

the documentation concerning the quality system;

(e)

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

3.3.2. The quality system shall ensure that the appliances or fittings are in conformity with the type described in the EU type-examination certificate and comply with the requirements of this Regulation that apply to them. U.K.

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:

(a)

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

(b)

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

(c)

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

(d)

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

(e)

the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

3.3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.3.2. U.K.

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.

3.3.4. 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. U.K.

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

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.

3.4. Surveillance under the responsibility of the notified body U.K.

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

3.4.2. 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: U.K.

(a)

the quality system documentation;

(b)

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

3.4.3. The notified body shall carry out periodic audits at least once every two years to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. U.K.

3.4.4. 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. U.K.

3.5. CE marking and EU declaration of conformity U.K.

3.5.1. 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. U.K.

3.5.2. 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. U.K.

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.

3.6. 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: U.K.

(a)

the documentation referred to in point 3.3.1;

(b)

the information relating to the change referred to in point 3.3.5, as approved;

(c)

the decisions and reports of the notified body referred to in points 3.3.5, 3.4.3 and 3.4.4.

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

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.

3.8. Authorised representative U.K.

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.

4. MODULE E: CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE U.K.

4.1. 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. U.K.

4.2. Manufacturing U.K.

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.

4.3. Quality system U.K.

4.3.1. 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. U.K.

The application shall include:

(a)

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

(b)

a written declaration that the same application has not been lodged with any other notified body;

(c)

all relevant information for the product category envisaged;

(d)

the documentation concerning the quality system; and

(e)

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

4.3.2. The quality system shall ensure compliance of the appliances or the fittings with the type described in the EU type-examination certificate and with the applicable requirements of this Regulation. U.K.

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:

(a)

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

(b)

the examinations and tests that will be carried out after manufacture;

(c)

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

(d)

the means of monitoring the effective operation of the quality system.

4.3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 4.3.2. U.K.

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.

4.3.4. 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. U.K.

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

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.

4.4. Surveillance under the responsibility of the notified body U.K.

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

4.4.2. 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: U.K.

(a)

the quality system documentation;

(b)

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

4.4.3. The notified body shall carry out periodic audits at least once every two years to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. U.K.

4.4.4. 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. U.K.

4.5. CE marking and EU declaration of conformity U.K.

4.5.1. 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. U.K.

4.5.2. 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. U.K.

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.

4.6. 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: U.K.

(a)

the documentation referred to in point 4.3.1;

(b)

the information relating to the change referred to in point 4.3.5, as approved;

(c)

the decisions and reports of the notified body referred to in points 4.3.5, 4.4.3 and 4.4.4.

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

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.

4.8. Authorised representative U.K.

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.

5. MODULE F: CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION U.K.

5.1. 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. U.K.

5.2. Manufacturing U.K.

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.

5.3. Verification U.K.

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.

5.4. Verification of conformity by examination and testing of every appliance or fitting U.K.

5.4.1. 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. U.K.

In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.

5.4.2. 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. U.K.

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.

5.5. Statistical verification of conformity U.K.

5.5.1. 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. U.K.

5.5.2. 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. U.K.

5.5.3. The notified body shall apply a sampling system with the following characteristics: U.K.

• a level of quality corresponding to a probability of acceptance of 95 %, with a non-conformity percentage of between 0,5 % and 1,5 %,

• a limit quality corresponding to a probability of acceptance of 5 % with a non-conformity percentage of between 5 % and 10 %.

5.5.4. If a lot is accepted, all appliances or fittings of the lot shall be considered approved, except for those appliances or fittings from the sample that have been found not to satisfy the tests. U.K.

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.

5.5.5. 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. U.K.

5.6. CE marking and EU declaration of conformity U.K.

5.6.1. 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. U.K.

5.6.2. 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. U.K.

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.

5.7. 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. U.K.

5.8. Authorised representative U.K.

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.

6. MODULE G: CONFORMITY BASED ON UNIT VERIFICATION U.K.

6.1. 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. U.K.

6.2. Technical documentation U.K.

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.

6.2.1. The technical documentation shall, wherever applicable, contain at least the following elements: U.K.

(a)

a general description of the appliance or the fitting;

(b)

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

(c)

descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the appliance or the fitting;

(d)

a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Regulation, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;

(e)

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

(f)

test reports;

(g)

instructions for installation and use, for appliances;

(h)

instructions for incorporation into an appliance or for assembly, for fittings.

6.2.2. Where appropriate, the manufacturer shall also submit to the notified body the following documents: U.K.

(a)

the EU type-examination certificate and the EU declaration of conformity relating to the fittings incorporated into the appliance;

(b)

attestations and certificates relating to the methods of manufacture and inspection and monitoring of the appliance or the fitting;

(c)

any other document making it possible for the notified body to improve its assessment.

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

6.3. Manufacturing U.K.

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.

6.4. Verification U.K.

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.

6.5. CE marking and EU declaration of conformity U.K.

6.5.1. 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. U.K.

6.5.2. 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. U.K.

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.

6.6. Authorised representative U.K.

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.