The Merchant Shipping (Marine Equipment) Regulations 2025

Schedule 2 United Kingdom Conformity Assessment Procedures

Regulations 4, 9, 10, 13 and 18 Part 1 (Module B) United Kingdom Conformity Assessment Examination (Module B) 1 In this Part 1, “United Kingdom conformity assessment examination” means the part of a conformity assessment procedure in which an approved body examines the technical design of marine equipment and verifies and attests that the technical design of the marine equipment meets the applicable requirements of these Regulations. 2 A United Kingdom conformity assessment examination may be carried out in either of the following ways— (a) examination of a specimen, representative of the production envisaged, of the complete product; or (b) assessment of the adequacy of the technical design of the marine equipment through examination of the technical documentation and supporting evidence referred to in paragraph 4, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the product. 3 (1) The manufacturer must lodge an application for United Kingdom conformity assessment examination with a single approved body of its choice. (2) The application must include— (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, its name and address as well; (b) a written declaration that the same application has not been lodged with any other approved body; (c) the technical documentation; (d) the specimens representative of the production envisaged; (e) the supporting evidence for the adequacy of the technical design of the marine equipment to meet the applicable requirements of these Regulations, which supporting evidence must— (i) mention any documents that have been used; and (ii) include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on the manufacturer's behalf and under the manufacturer's responsibility. (3) The approved body may request further specimens representative of the production envisaged if needed for carrying out the test programme. 4 The technical documentation referred to in paragraph 3(2)(c) must— (a) make it possible to assess the conformity of the marine equipment with the applicable international standards and must include an adequate analysis and assessment of the risks; (b) specify the applicable requirements in respect of the marine equipment and cover, as far as relevant for the assessment, the design, manufacture and operation of the marine equipment; (c) contain, wherever applicable, at least the following elements— (i) a general description of the marine equipment; (ii) conceptual design and manufacturing drawings and schemes of components, sub-assemblies and circuits; (iii) descriptions and explanations necessary for the understanding of those drawings and schemes and of the operation of the marine equipment; (iv) a list of the requirements and testing standards which are applicable to the marine equipment concerned in accordance with these Regulations, together with a description of the solutions adopted to meet those requirements; (v) results of design calculations made and examinations carried out; and (vi) test reports. 5 (1) The approved body must examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the marine equipment. (2) When examining a specimen, the approved body must— (a) verify that the specimen has been manufactured in conformity with the technical documentation; (b) identify the elements which have been designed in accordance with the relevant applicable requirements of these Regulations and the testing standards, as well as the elements which have been designed without applying the relevant provisions of those standards; (c) carry out appropriate examinations and tests, or have them carried out in accordance with these Regulations; (d) agree with the manufacturer on a location where the examinations and tests will be carried out. (3) The approved body must draw up an evaluation report that records the activities taken in accordance with sub-paragraphs (1) and (2) and their outcomes and, without prejudice to its obligations in relation to the Secretary of State, the approved body may disclose the content of that report, in full or in part, only with the agreement of the manufacturer. 6 (1) Where the equipment meets the requirements of the applicable international standards that apply to the equipment concerned, the approved body must issue a United Kingdom conformity assessment examination certificate to the manufacturer, which must contain— (a) the name and address of the manufacturer; (b) the conclusions of the examination; (c) the conditions (if any) for its validity; (d) all relevant information to allow the conformity of manufactured products with the examined equipment to be evaluated and to allow for in-service control; and (e) the necessary data for identification of the approved equipment. (2) The United Kingdom conformity assessment examination certificate may have one or more annexes attached. (3) Where the equipment does not satisfy the applicable requirements of the applicable international standards, the approved body must refuse to issue a United Kingdom conformity assessment examination certificate and must inform the applicant accordingly, giving detailed reasons for its refusal. 7 (1) A manufacturer must inform the approved body that holds the technical documentation relating to the United Kingdom conformity assessment examination certificate of all modifications to approved equipment that may affect the conformity of the equipment with the requirements of the applicable international standards or the conditions for validity of the certificate. (2) Modifications referred to in sub-paragraph (1) require additional approval in accordance with the terms of Part 2 of Schedule 2, which approval shall be recorded in the form of an addition to the original United Kingdom conformity assessment examination certificate. (3) Where approved equipment no longer complies with applicable requirements, the approved body must determine whether further testing or a new conformity assessment procedure is necessary in relation to the additional approval referred to in sub-paragraph (2). 8 (1) Each approved body must inform the Secretary of State about all the United Kingdom conformity assessment examination certificates, and any additions to those certificates, which it has issued or withdrawn, and must, periodically or on request, make available to the Secretary of State the list of such certificates and any additions to those certificates which it has refused, suspended or otherwise restricted. (2) Each approved body must inform the other approved bodies about all the United Kingdom conformity assessment examination certificates, and any additions to those certificates, which it has refused, withdrawn, suspended or otherwise restricted. (3) An approved body must, on request, provide the other approved bodies with a copy of the United Kingdom conformity assessment examination certificates, and any additions to those certificates, which it has issued. (4) An approved body must keep a copy of United Kingdom conformity assessment examination certificate issued by it together with the documentation referred to in sub-paragraph (5) until the expiry of the validity of that certificate. (5) The documentation referred to in sub-paragraph (4) is any annexes and additions to the certificate and any associated technical documents including the technical documentation. (6) The Secretary of State may, on request, obtain— (a) a copy of a United Kingdom conformity assessment examination certificate from an approved body that it has issued, refused, suspended or restricted; (b) a copy of the technical documentation and the results of the examinations carried out by approved bodies. (7) A manufacturer must keep a copy of the United Kingdom conformity assessment examination certificate, its annexes and additions, together with the technical documentation, at the disposal of the Secretary of State for a period of at least 10 years after the United Kingdom conformity mark has been affixed on the last product manufactured and, in no case for a period shorter than the expected life of the marine equipment concerned. (8) A manufacturer's authorised representative may lodge the application referred to in paragraph 3 and fulfil the obligations set out in paragraphs 7(1) and 8(7), provided such functions are within scope of the terms of the authorised representative’s appointment. Part 2 (Module D) Conformity of equipment based on quality assurance of the production process (Module D) 9 Pursuant to this Part 2, a manufacturer must fulfil the obligations laid down in paragraphs 10 and 13 and must allow surveillance as specified in paragraph 12. Manufacturing 10 A manufacturer must operate an approved quality system for production, final product inspection and testing of the products concerned as specified in paragraph 11, and be subject to surveillance as specified in paragraph 12. Quality system 11 (1) A manufacturer that seeks to obtain approval for its quality system for manufacture must lodge an application for assessment with an approved body of its choice. (2) The application must include— (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, its name and address as well; (b) a written declaration that the same application has not been lodged with any other approved body; (c) all relevant information for the category of marine equipment referred to in Annex 1 of Merchant Shipping Notice MSN 1874 to which the quality system would apply; (d) documentation concerning the quality system; (e) the technical documentation for the approved equipment and a copy of the United Kingdom conformity assessment examination certificate. (3) The quality system must ensure that the products are in conformity with the equipment described in the United Kingdom conformity assessment examination certificate and that they comply with the applicable international standards that apply to them. (4) The manufacturer must document in the form of written policies, procedures and instructions all the elements, requirements and provisions of the quality system that it has adopted. (5) The quality system documentation must enable a consistent interpretation of the programmes, plans, manuals and records and must include 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, including inspection reports and test data, calibration data and qualification reports on the personnel concerned; and (e) the means of monitoring the achievement of the required product quality and the effective operation of the quality system. (6) The approved body must assess the quality system to determine whether it satisfies the requirements set out in sub-paragraphs (3), (4) and (5). (7) The auditing team of the approved body must include members with experience in quality management and must include at least one member with — (a) experience of evaluation in the relevant marine equipment field; (b) experience of the marine technology concerned; (c) knowledge of the applicable requirements of the applicable international standards. (8) The audit carried out by the approved body must include — (a) an assessment visit to the manufacturer's premises, and (b) a review of the technical documentation for the approved equipment in order to verify the manufacturer's ability to identify the applicable international standards and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements. (9) The approved body must notify the manufacturer of its decision with regard to approval of the quality system and that notification must contain the conclusions of the audit and the reasoned assessment decision. (10) The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and maintain the quality system so that it remains adequate and efficient. (11) The manufacturer must keep the approved body that has approved the quality system informed of any intended changes to the quality system. (12) Where the manufacturer proposes changes to the quality system, the approved body must— (a) evaluate any proposed changes; (b) decide, based on the information provided, whether the modified quality system would continue to satisfy the requirements set out in sub-paragraphs (3), (4) and (5) or whether the manufacturer would be required to lodge a new application pursuant to sub-paragraph (1); (c) notify the manufacturer of its decision and that notification must contain the conclusions of the examination and the reasoned assessment decision. Surveillance under the responsibility of the approved body 12 (1) The manufacturer must allow the approved body access to the manufacture, inspection, testing and storage sites, and must provide it with all necessary information, in particular— (a) the quality system documentation; (b) the quality records, including inspection reports and test data, calibration data and qualification reports on the personnel concerned. (2) The approved body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system, and must provide the manufacturer with an audit report. (3) The approved body may make unannounced visits to the manufacturer and, during such visits may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. (4) Where the approved body has made an unannounced visit to the manufacturer, the approved body must provide the manufacturer with a visit report and, if tests have been carried out during such a visit, with a test report. United Kingdom conformity marking and declaration of conformity 13 (1) The manufacturer must affix the United Kingdom conformity mark and the identification number of the approved body that has approved the quality system to each individual product that is in conformity with the equipment standard described in the United Kingdom conformity assessment examination certificate and that satisfies the applicable international standards. (2) The manufacturer must draw up a written United Kingdom declaration of conformity for each product model and keep it at the disposal of the Secretary of State for a period of at least 10 years after the United Kingdom conformity marking has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned. (3) The United Kingdom declaration of conformity must identify the marine equipment model for which it has been drawn up and a copy of the United Kingdom declaration of conformity must be made available to the Secretary of State on request. (4) The manufacturer must keep at the disposal of the Secretary of State, for a period of at least 10 years after the United Kingdom conformity mark has been affixed on the last product manufactured, and in no case for a period shorter than the expected life of the marine equipment concerned— (a) everything comprising the application referred to in paragraphs 11(1) and 11(2); (b) any change referred to in paragraph 11(11), which has been approved; (c) the decisions and reports of the approved body referred to in paragraph 11(12)(c), 12(2) and 12(4). (5) Each approved body must inform the Secretary of State of quality system approvals that it has issued or withdrawn and must, periodically or upon request, make available to the Secretary of State the list of quality system approvals that it has refused, suspended or otherwise restricted. (6) Each approved body must inform the other United Kingdom approved bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted and, on request, of quality system approvals which it has issued. Authorised representative 14 The manufacturer's obligations set out in paragraphs 11(1), (2) and (11) and 13(1), (2), (3) and (4) may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate referred to in regulation 14(1). Part 3 (Module E) Conformity of equipment based on product quality assurance (Module E) 15 (1) Pursuant to this Part 3, a manufacturer must fulfil the obligations laid down in paragraphs 16 and 19. (2) It is the manufacturer's sole responsibility to ensure and declare that the marine equipment concerned is in conformity with the equipment standard described in the United Kingdom conformity assessment examination certificate and that it satisfies the applicable international standards that apply to it. Manufacturing 16 A manufacturer must operate an approved quality system for final product inspection and testing of the products concerned as specified in paragraph 17, and must be subject to surveillance as specified in paragraph 18. Quality system 17 (1) A manufacturer must lodge an application for assessment of its quality system for the marine equipment concerned with an approved body of its choice. (2) The application must include — (a) the name and address of the manufacturer and if the application is lodged by the authorised representative, its name and address as well; (b) a written declaration that the same application has not been lodged with any other approved body; (c) all relevant information for the category of marine equipment referred to in Annex 1 of Merchant Shipping Notice MSN 1874 to which the quality system would apply; (d) the documentation concerning the quality system; (e) the technical documentation for the approved equipment and a copy of the United Kingdom conformity assessment examination certificate. (3) The quality system must ensure compliance of the products with the equipment described in the United Kingdom conformity assessment examination certificate and with the applicable international standards. (4) The manufacturer must document in the form of written policies, procedures and instructions all the elements, requirements and provisions of the quality system that it has adopted. (5) The quality system documentation must enable a consistent interpretation of the programmes, plans, manuals and records and must include 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, including inspection reports and test data, calibration data and qualification reports on the personnel concerned; (d) the means of monitoring the effective operation of the quality system. (6) The approved body must assess the quality system to determine whether it satisfies the requirements set out in sub-paragraphs (3), (4) and (5). (7) The auditing team of the approved body must include members with experience in quality management systems and must include at least one member with— (a) experience of evaluation in the relevant marine equipment field; (b) experience of the marine equipment technology concerned; (c) knowledge of the applicable international standards. (8) The audit carried out by the approved body must include— (a) an assessment visit to the manufacturer's premises, and (b) a review of the technical documentation for the approved equipment in order to verify the manufacturer's ability to identify the applicable international standards and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements. (9) The approved body must notify the manufacturer of its decision with regard to approval of the quality system and that notification must contain the conclusions of the audit and the reasoned assessment decision. (10) The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. (11) The manufacturer must keep the approved body that has approved the quality system informed of any intended change to the quality system. (12) Where the manufacturer proposes changes to the quality system, the approved body must— (a) evaluate any proposed changes; (b) decide, based on the information provided, whether the modified quality system would continue to satisfy the requirements set out in sub-paragraphs (3), (4) and (5) or whether the manufacturer would be required to lodge a new application pursuant to sub-paragraph (1); (c) notify the manufacturer of its decision and that notification must contain the conclusions of the examination and the reasoned assessment decision. Surveillance under the responsibility of the approved body 18 (1) The manufacturer must allow the approved body access to the manufacture, inspection, testing and storage sites, and must provide it with all necessary information, in particular— (a) the quality system documentation; (b) the quality records, including inspection reports and test data, calibration data and qualification reports on the personnel concerned. (2) The approved body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system, and must provide the manufacturer with an audit report. (3) The approved body may make unannounced visits to the manufacturer and, during such visits may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. (4) Where the approved body has made an unannounced visit to the manufacturer, the approved body must provide the manufacturer with a visit report and, if tests have been carried out during such a visit, with a test report. United Kingdom conformity marking and declaration of conformity 19 (1) The manufacturer must affix the United Kingdom conformity mark and the identification number of the approved body that has approved the quality system to each individual product that is in conformity with the equipment standard described in the United Kingdom conformity assessment examination certificate and that satisfies the applicable international standards. (2) The manufacturer must draw up a written United Kingdom declaration of conformity for each product model and keep it at the disposal of the Secretary of State for a period of at least 10 years after the United Kingdom conformity mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned. (3) The United Kingdom declaration of conformity must identify the marine equipment model for which it has been drawn up and a copy of the United Kingdom declaration of conformity must be made available to the Secretary of State on request. (4) The manufacturer must keep at the disposal of the Secretary of State for a period of at least 10 years after the United Kingdom conformity mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned— (a) everything comprising the application referred to in paragraphs 17(1) and 17(2); (b) details of any change referred to in paragraph 17(12) which has been approved; (c) any decisions and reports of the approved body referred to in paragraphs 17(12), 18(2) and 18(4). (5) Each approved body must inform the Secretary of State of quality system approvals that it has issued or withdrawn and must, periodically or on request, make available to the Secretary of State the list of quality system approvals that it has refused, suspended or otherwise restricted. (6) Each approved body must inform the other United Kingdom approved bodies of quality system approvals which it has refused, suspended or withdrawn, and, on request, of quality system approvals which it has issued. Authorised representative 20 The manufacturer's obligations set out in paragraphs 17(1), (2), (10) and (11) and 19(1), (2), (3) and (4) may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate referred to in regulation 14(1). Part 4 (Module F) Conformity of equipment based on product verification (Module F) 21 (1) Pursuant to this Part 4, a manufacturer must fulfil the obligations laid down in paragraphs 22, 25(1) and 26. (2) It is the manufacturer's sole responsibility to ensure and declare that the products concerned, which have been subject to the verification procedures set out in paragraph 23, are in conformity with the equipment standard described in the United Kingdom conformity assessment examination certificate and that they satisfy the applicable international standards. Manufacturing 22 A manufacturer must take all measures necessary so that the manufacturing procedure and its monitoring ensure conformity of the manufactured products with the equipment described in the United Kingdom conformity assessment examination certificate and with applicable international standards. Verification 23 (1) An approved body of the manufacturer's choice must carry out appropriate examinations and tests in order to check the conformity of the products with the approved equipment described in the United Kingdom conformity assessment examination certificate and with applicable international standards. (2) The examinations and tests to check conformity of the products with the applicable international standards must be carried out, at the manufacturer's choice, either by examination and testing of every product as specified in paragraph 24 or by examination and testing of the products on a statistical basis as specified in paragraph 25. Verification of conformity by examination and testing of every product 24 (1) Where verification is to be by examination and testing of every product, all products must be individually examined and tested in accordance with these Regulations, in order to verify conformity with the approved equipment described in the United Kingdom conformity assessment examination certificate and with applicable international standards. (2) An approved body must issue a certificate of conformity in respect of the examinations and tests carried out and must affix its identification number to each approved product or have it affixed under its responsibility. (3) The manufacturer must keep the certificates of conformity available for inspection by the Secretary of State for a period of at least 10 years after the United Kingdom conformity mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned. Statistical verification of conformity 25 (1) Where verification is to be by examination and testing of the products on a statistical basis, the manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and must present its products for verification in the form of homogeneous lots. (2) A random sample must be taken from each lot and all products in the random sample must be individually examined and tested in accordance with these Regulations, in order to ensure their conformity with applicable international standards and to determine whether the lot is accepted or rejected. (3) If a lot is accepted— (a) all products of the lot must be considered approved, except for those products from the sample that have been found not to satisfy the tests; (b) the approved body must issue a certificate of conformity in respect of the examinations and tests carried out, and must affix its identification number to each approved product or have it affixed under its responsibility; (c) the manufacturer must keep the certificate of conformity at the disposal of the Secretary of State for a period of at least 10 years after the United Kingdom conformity mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned. (4) If a lot is rejected, all products of the lot must be considered rejected and the approved body must inform the manufacturer accordingly. (5) In the event of the frequent rejection of lots, the approved body may suspend the examination and testing of the products on a statistical basis. United Kingdom conformity marking and declaration of conformity 26 (1) The manufacturer must affix the United Kingdom conformity mark and, under the responsibility of the approved body referred to in paragraph 23, the latter's identification number to each individual product that is in conformity with the approved equipment described in the United Kingdom conformity assessment examination certificate and that satisfies applicable international standards. (2) The manufacturer must draw up a written United Kingdom declaration of conformity for each product model and keep it at the disposal of the Secretary of State for a period of at least 10 years after the United Kingdom conformity mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned. (3) The United Kingdom declaration of conformity must identify the marine equipment model for which it has been drawn up and a copy of the United Kingdom declaration of conformity must be made available to the Secretary of State upon request. (4) If the approved body agrees, under its responsibility, the manufacturer may affix the approved body's identification number to the products during the manufacturing process. Authorised representative 27 The manufacturer's obligations under this Part may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate referred to in regulation 14(1), but an authorised representative may not fulfil the manufacturer's obligations set out in paragraphs 22 and 25(1). Part 5 (Module G) Conformity of equipment based on unit verification (Module G) 28 (1) Pursuant to this Part 5, a manufacturer must fulfil the obligations laid down in paragraphs 29, 30 and 32. (2) It is the manufacturer's sole responsibility to ensure and declare that the product concerned, which has been subject to the verification provisions set out in paragraph 31, is in conformity with the applicable international standards. Technical documentation 29 (1) A manufacturer must draw up the technical documentation and make it available to the approved body referred to in paragraph 31. (2) The technical documentation referred to in sub-paragraph (1) must— (a) make it possible to assess the product's conformity with the relevant requirements of these Regulations and must include an analysis and assessment of the risks; (b) specify the applicable requirements in respect of the product and cover, as far as relevant for the assessment, the design, manufacture and operation of the product; (c) contain, wherever applicable, at least the following elements— (i) a general description of the product; (ii) conceptual design and manufacturing drawings and schemes of component, sub-assemblies and circuits; (iii) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product; (iv) a list of the requirements and testing standards which are applicable to the marine equipment concerned in accordance with these Regulations and descriptions of the solutions adopted to meet those requirements; (v) results of design calculations made and examinations carried out; (vi) test reports. (3) A manufacturer must keep the technical documentation at the disposal of the Secretary of State for a period of at least 10 years after the United Kingdom conformity mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned. Manufacturing 30 A manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with applicable international standards. Verification 31 (1) An approved body of the manufacturer's choice must carry out appropriate examinations and tests in accordance with these Regulations in order to check the conformity of the product with applicable international standards. (2) The approved body must issue a certificate of conformity in respect of the examinations and tests carried out and must affix its identification number to the approved product or have it affixed under its responsibility. (3) The manufacturer must keep the certificates of conformity at the disposal of the Secretary of State for a period of at least 10 years after the United Kingdom conformity mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned. United Kingdom conformity marking and declaration of conformity 32 (1) The manufacturer must affix the United Kingdom conformity mark and, under the responsibility of the approved body referred to in paragraph 31, the latter's identification number, to each product that satisfies the applicable international standards. (2) The manufacturer must draw up a written United Kingdom declaration of conformity and keep it at the disposal of the Secretary of State for a period of at least 10 years after the United Kingdom conformity mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned. The United Kingdom declaration of conformity must identify the product for which it has been drawn up. (3) A copy of the United Kingdom declaration of conformity must be made available to the Secretary of State on request. Authorised representative 33 The manufacturer's obligations set out in paragraphs 29 and 32 may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate referred to in regulation 14(1).