The Recreational Craft Regulations 2017

[F1 MODULE B E+W+S Type examination

Textual Amendments

F1 Sch. 15 inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 28 para. 54 (with Sch. 28 para. 41) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Type examination E+W+S

1.   Type examination is the part of a conformity assessment procedure in which an approved body—

(a) examines the technical design of a product; and

(b) verifies and attests that the technical design of the product meets the essential requirements that apply to it.

How type examination must be carried out, etc. E+W+S

2.— (1) The conformity assessment procedure must include an assessment of the adequacy of the technical design of the product through examination of the technical documentation and supporting evidence referred to in paragraph 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the product (combination of production type and design type).

(2) The assessment referred to in sub-paragraph (1) may cover several versions of the product if—

(a) the differences between the versions of the product do not affect the level of safety and the other requirements concerning the performance of the product; and

(b) the different versions of the product are referred to in the corresponding type examination certificate, if necessary by means of amendments to the original certificate.

Application for type examination E+W+S

3.— (1) The manufacturer must lodge an application for type examination with a single approved body of the manufacturer's choice.

(2) The application must include—

(a) the name and address of the manufacturer and, if the application is lodged by an authorised representative, the name and address of the authorised representative;

(b) a 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; and

(e) the supporting evidence for the adequacy of the technical design solution.

(3) The manufacturer must, if requested by the approved body, provide further specimens if needed for carrying out the test programme.

(4) The technical documentation referred to in sub-paragraph (2)(c) must—

(a) make it possible to assess the product's conformity with the essential requirements that apply to it;

(b) include an adequate analysis and assessment of any risks;

(c) specify the essential requirements that apply to the product; and

(d) cover, as far as relevant for the assessment, the design, manufacture and operation of the product.

(5) The technical documentation referred to in sub-paragraph (2)(c) must contain, where applicable, at least the following—

(a) a general description of the product;

(b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies and circuits;

(c) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product;

(d) a list of the designated standards and other relevant technical specifications applied in full or in part (and where designated standards have been applied in part, the technical documentation must specify the parts which have been applied);

(e) where designated standards have not been applied, descriptions of the solutions adopted to meet the essential requirements;

(f) results of design calculations made and examinations carried out;

(g) test reports.

(5) The supporting evidence for the adequacy of the technical design solution referred to in sub-paragraph (2)(e) must—

(a) mention any documents that have been used, in particular where the relevant designated standards or technical specifications have not been applied in full; and

(b) 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.

Examination, etc. by approved body E+W+S

4.— (1) The approved body must examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the product.

(2) The approved body must—

(a) verify that the specimen has 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 designated standards or technical specifications, as well as the elements which have been designed without applying the relevant provisions of those standards or specifications;

(b) 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 designated standards or technical specifications, these have been applied correctly;

(c) carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant designated standards or technical specifications have not been applied, the solutions adopted by the manufacturer meet the essential requirements covered by the standards or specifications; and

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

Evaluation report E+W+S

5.   The approved body must draw up an evaluation report that records the activities undertaken in accordance with paragraph 4 and their outcomes. Without prejudice to its obligations vis-à vis the Secretary of State, the approved body may release the content of the report, in full or in part, only with the agreement of the manufacturer.

Type examination certificate E+W+S

6.— (1) Where the type meets the essential requirements that apply to the product concerned, the approved body must issue a type examination certificate to the manufacturer.

(2) The certificate (which may have one or more annexes attached) 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) the necessary data for identification of the approved type; and

(e) all relevant information to allow the conformity of manufactured products with the examined type to be evaluated and to allow for in-service control.

(3) Where the type does not meet the essential requirements that apply to the product concerned, the approved body must refuse to issue a type examination certificate and must inform the applicant accordingly, giving detailed reasons for its refusal.

Changes E+W+S

7.— (1) The approved body must 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 essential requirements that apply to the product concerned and must determine whether such changes require further investigation. If so, the approved body must inform the manufacturer accordingly.

(2) The manufacturer must inform the approved body that holds the technical documentation relating to the type examination certificate of all modifications to the approved type that may affect the conformity of the product with the essential requirements that apply to it or the conditions for validity of the certificate. Such modifications require additional approval in the form of an addition to the original type examination certificate.

Approved body's duties in respect of type examination certificates E+W+S

8.— (1) The approved body must inform the Secretary of State about the type examination certificates and any additions thereto which it has issued or withdrawn and must, periodically or upon request, make available to the Secretary of State a list of certificates and any additions thereto refused, suspended or otherwise restricted.

(2) The approved body must inform the other approved bodies about the type examination certificates and any additions thereto which it has refused, withdrawn, suspended or otherwise restricted and, upon request, about such certificates and additions thereto which it has issued.

(3) The approved body must, on request, provide the Secretary of State and other approved bodies with a copy of the type examination certificates and additions thereto which it has issued.

(4) The approved body must, on request, provide the Secretary of State with a copy of the technical documentation and the results of the examinations carried out by the approved body.

(5) The approved body must keep a copy of the 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 the certificate.

Manufacturer's duties in respect of type examination certificates E+W+S

9.   The manufacturer must keep a copy of the type examination certificate, its annexes and additions together with the technical documentation at the disposal of the enforcing authority for 10 years after the product has been placed on the market.]