PART 1 U.K.Module B: EU-type Examination
1. EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of an apparatus and verifies and attests that the technical design of the apparatus meets the essential requirements set out in paragraph 1 of Schedule 1.E+W+S
1. EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of an apparatus and verifies and attests that the technical design of the apparatus meets the essential requirements set out in paragraph 1 of Schedule 1.N.I.
2. EU-type examination must be carried out by an assessment of the adequacy of the technical design of the apparatus through examination of the technical documentation referred to in paragraphs 3 and 4 without examination of a specimen (design type). It may be restricted to some aspects of the essential requirements as specified by the manufacturer or the manufacturer's authorised representative.E+W+S
2. EU-type examination must be carried out by an assessment of the adequacy of the technical design of the apparatus through examination of the technical documentation referred to in paragraphs 3 and 4 without examination of a specimen (design type). It may be restricted to some aspects of the essential requirements as specified by the manufacturer or the manufacturer's authorised representative.N.I.
3. The manufacturer must lodge an application for EU-type examination with a single notified body of the manufacturer's choice. The application must specify the aspects of the essential requirements for which examination is requested and must include—E+W+S
(a)the name and address of the manufacturer or, if the application is lodged by an authorised representative, the name and address of the authorised representative and of the manufacturer;
(b)a written declaration that the same application has not been lodged with another notified body;
(c)the technical documentation.
3. The manufacturer must lodge an application for EU-type examination with a single notified body of the manufacturer's choice. The application must specify the aspects of the essential requirements for which examination is requested and must include—N.I.
(a)the name and address of the manufacturer or, if the application is lodged by an authorised representative, the name and address of the authorised representative and of the manufacturer;
(b)a written declaration that the same application has not been lodged with another notified body;
(c)the technical documentation.
4. The technical documentation referred to in paragraph 3(c) of this Schedule must make it possible to assess the conformity of the apparatus with the applicable requirements of these Regulations and must include an adequate analysis and assessment of the risks posed by the apparatus. The technical documentation must specify the applicable requirements and cover, as far as is relevant for the assessment, the design, manufacture and operation of the apparatus. The technical documentation must contain, where applicable, at least the following elements—E+W+S
(a)a general description of the apparatus;
(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 apparatus;
(d)a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal and, where the harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of these Regulations, including a list of other relevant technical specifications applied. In the event of a partly applied harmonised standard, the technical documentation must specify the parts of the standard that have been applied;
(e)results of design calculations made, examinations carried out, etc.;
(f)test reports.
4. The technical documentation referred to in paragraph 3(c) of this Schedule must make it possible to assess the conformity of the apparatus with the applicable requirements of these Regulations and must include an adequate analysis and assessment of the risks posed by the apparatus. The technical documentation must specify the applicable requirements and cover, as far as is relevant for the assessment, the design, manufacture and operation of the apparatus. The technical documentation must contain, where applicable, at least the following elements—N.I.
(a)a general description of the apparatus;
(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 apparatus;
(d)a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal and, where the harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of these Regulations, including a list of other relevant technical specifications applied. In the event of a partly applied harmonised standard, the technical documentation must specify the parts of the standard that have been applied;
(e)results of design calculations made, examinations carried out, etc.;
(f)test reports.
5. The notified body must examine the technical documentation to assess the adequacy of the technical design of the apparatus in relation to the aspects of the essential requirements for which examination is requested.E+W+S
5. The notified body must examine the technical documentation to assess the adequacy of the technical design of the apparatus in relation to the aspects of the essential requirements for which examination is requested.N.I.
6. The notified body must draw up an evaluation report which records the activities undertaken in accordance with paragraph 5 and their outcomes. Without prejudice to its obligations to the notifying authorities, the notified body must release the content of that report, in full or in part, only with the agreement of the manufacturer.E+W+S
6. The notified body must draw up an evaluation report which records the activities undertaken in accordance with paragraph 5 and their outcomes. Without prejudice to its obligations to the notifying authorities, the notified body must release the content of that report, in full or in part, only with the agreement of the manufacturer.N.I.
7. Where the type meets the requirements of these Regulations that apply to the apparatus concerned, the notified body must issue an EU-type examination certificate to the manufacturer.E+W+S
7. Where the type meets the requirements of these Regulations that apply to the apparatus concerned, the notified body must issue an EU-type examination certificate to the manufacturer.N.I.
8. The EU-type examination certificate, which may be accompanied by one or more annexes, must contain—E+W+S
(a)the name and address of the manufacturer;
(b)the conclusions of the examination of the apparatus;
(c)the aspects of the essential requirements covered by the examination;
(d)the conditions (if any) for the validity of the certificate; and
(e)the necessary data for the identification of the approved type.
8. The EU-type examination certificate, which may be accompanied by one or more annexes, must contain—N.I.
(a)the name and address of the manufacturer;
(b)the conclusions of the examination of the apparatus;
(c)the aspects of the essential requirements covered by the examination;
(d)the conditions (if any) for the validity of the certificate; and
(e)the necessary data for the identification of the approved type.
9. The EU-type examination certificate and any annexes to that certificate must contain all relevant information to allow the conformity of manufactured apparatus with the examined type to be evaluated and to allow for in-service control.E+W+S
9. The EU-type examination certificate and any annexes to that certificate must contain all relevant information to allow the conformity of manufactured apparatus with the examined type to be evaluated and to allow for in-service control.N.I.
10. Where the type does not satisfy the applicable requirements of these Regulations, the notified body must refuse to issue the EU-type examination certificate and must inform the applicant accordingly, giving detailed reasons for its refusal.E+W+S
10. Where the type does not satisfy the applicable requirements of these Regulations, the notified body must refuse to issue the EU-type examination certificate and must inform the applicant accordingly, giving detailed reasons for its refusal.N.I.
11. The notified 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 applicable requirements of these Regulations and must determine whether such changes require further investigation. If so, the notified body must inform the manufacturer accordingly.E+W+S
11. The notified 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 applicable requirements of these Regulations and must determine whether such changes require further investigation. If so, the notified body must inform the manufacturer accordingly.N.I.
12. The manufacturer must 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 apparatus with the essential requirements of these Regulations or the conditions for validity of that certificate. Such modifications must require additional approval in the form of an addition to the EU-type examination certificate.E+W+S
12. The manufacturer must 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 apparatus with the essential requirements of these Regulations or the conditions for validity of that certificate. Such modifications must require additional approval in the form of an addition to the EU-type examination certificate.N.I.
13. Each notified body must inform its notifying authority of any EU-type examination certificates or any additions thereto, which it has issued or withdrawn and, must periodically or upon request, make available to its notifying authority a list of such certificates and additions thereto that it has refused, suspended or otherwise restricted.E+W+S
13. Each notified body must inform its notifying authority of any EU-type examination certificates or any additions thereto, which it has issued or withdrawn and, must periodically or upon request, make available to its notifying authority a list of such certificates and additions thereto that it has refused, suspended or otherwise restricted.N.I.
14. Each notified body must inform the other notified bodies of any EU-type examination certificates or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted. Upon request from another notified body, a notified body must inform the requesting body of the EU-type examination certificates that it has issued.E+W+S
14. Each notified body must inform the other notified bodies of any EU-type examination certificates or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted. Upon request from another notified body, a notified body must inform the requesting body of the EU-type examination certificates that it has issued.N.I.
15. The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificate and any additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examination carried out by the notified body. The notified body must 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.E+W+S
15. The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificate and any additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examination carried out by the notified body. The notified body must 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.N.I.
16. The manufacturer must 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 apparatus has been placed on the market.E+W+S
16. The manufacturer must 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 apparatus has been placed on the market.N.I.
17. The manufacturer's authorised representative may lodge the application referred to in paragraph 3 and fulfil the obligations set out in paragraphs 12 and 16 of this Schedule, provided that these obligations are specified in the authorised representative's written mandate.U.K.