PART 8 -- Conformity assessment Modules B and C -- EU-type examination and conformity to type based on internal production control

• Regulation (EU) 2020/1058 found in: Unmanned Aircraft Systems (2019/947 and 2019/945) Part-UAS (Jul 2024)

PART 8 — Conformity assessment Modules B and C — EU-type examination and conformity to type based on internal production control Regulation (EU) 2020/1058 When reference is made to this Part, the conformity assessment procedure shall follow Modules B (EU-type examination) and C (Conformity to type based on internal production control) of this Part. **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 the product and verifies and attests that the technical design of the product meets the applicable requirements set out in Parts [1](#_DxCrossRefBm1106656890) to [6](#_DxCrossRefBm1106657030), [16](#_DxCrossRefBm1106656798) and [17](#_DxCrossRefBm1106656805). 2. EU-type examination shall be carried out by an assessment of the adequacy of the technical design of the product through examination of the technical documentation and supporting evidence referred to in point 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). 3. The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice. The application shall include: (1) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (2) a written declaration that the same application has not been lodged with any other notified body; (3) the technical documentation; the technical documentation shall make it possible to assess the product’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 contain, wherever applicable, the elements set out in [Article 17](#_DxCrossRefBm1106657034) of this Regulation; (4) the specimens representative of the production envisaged; the notified body may request further specimens if needed for carrying out the test programme; (5) 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 and/or technical specifications have not been applied or 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. 4. The notified body shall: For the product: (1) examine the technical documentation and supporting evidence to assess the adequacy of the product’s technical design. For the specimen(s): (2) verify that the specimen(s) has (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 and/or technical specifications, as well as the elements which have been designed without applying the relevant provisions of those standards; (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 and/or technical specifications, these have been applied correctly; (4) carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards and/or technical specifications have not been applied, the solutions adopted by the manufacturer meet the corresponding essential requirements of the legislative instrument; (5) agree with the manufacturer on a location where the examinations and tests will be carried out. 5. The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations as provided in point 8, the notified body shall release the content of this report, in full or in part, only with the agreement of the manufacturer. 6. Where the type meets the requirements of this Regulation, the notified body shall issue an EU‑type examination certificate to the manufacturer. This certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the relevant aspects of the requirements covered by the examination, the conditions (if any) for its validity, and the data necessary for the identification of the approved type. The certificate may have one or more annexes attached to it. The EU certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products with the examined type to be evaluated and to allow for in service control. Where the type does not satisfy the applicable requirements of this Regulation, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. 7. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicates that the approved type may no longer comply with the applicable requirements of this Regulation, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the product’s conformity with the essential requirements of this Regulation or the conditions for the certificate’s validity. Such modifications shall require additional approval and attached to the original EU-type examination certificate. 8. Each notified body shall inform its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of certificates and/or any additions thereto refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the 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 a reasoned 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 for 10 years after the product has been assessed or until the validity of the certificate expires. 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 product has been placed on the market. 10. The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate. **Module C** **Conformity to type based on internal production control** 1. Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the applicable requirements of this Regulation. 2. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with the approved type described in the EU-type examination certificate and with the applicable requirements set out in Parts [1](#_DxCrossRefBm1106656890) to [6](#_DxCrossRefBm1106657030), [16](#_DxCrossRefBm1106656798) and [17](#_DxCrossRefBm1106656805). 3. CE marking and EU declaration of conformity (1) The manufacturer shall affix the CE marking and, when relevant, the UA class identification label in accordance with Articles [15](#_DxCrossRefBm1106657047) and [16](#_DxCrossRefBm1106657048) of this Regulation to each product that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements set out in Parts [1](#_DxCrossRefBm1106656890) to [6](#_DxCrossRefBm1106657030), [16](#_DxCrossRefBm1106656798) and [17](#_DxCrossRefBm1106656805). (2) The manufacturer shall draw up a written EU declaration of conformity for each product type and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The EU declaration of conformity shall clearly identify the product type for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. 4. Authorised representative The manufacturer’s obligations set out in point 3 may be fulfilled by their authorised representative, on their behalf and under their responsibility, provided that this is specified in the mandate. #### PART 8 — Conformity assessment Modules B and C — EU-type examination and conformity to type based on internal production control *Regulation (EU) 2020/1058* When reference is made to this Part, the conformity assessment procedure shall follow Modules B (EU-type examination) and C (Conformity to type based on internal production control) of this Part. **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 the product and verifies and attests that the technical design of the product meets the applicable requirements set out in Parts [1](#_DxCrossRefBm1295819208) to [6](#_DxCrossRefBm1295819348), [16](#_DxCrossRefBm1295819115) and [17](#_DxCrossRefBm1295819122). 2. EU-type examination shall be carried out by an assessment of the adequacy of the technical design of the product through examination of the technical documentation and supporting evidence referred to in point 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). 3. The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice. The application shall include: (1) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (2) a written declaration that the same application has not been lodged with any other notified body; (3) the technical documentation; the technical documentation shall make it possible to assess the product’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 contain, wherever applicable, the elements set out in [Article 17](#_DxCrossRefBm1295819351) of this Regulation; (4) the specimens representative of the production envisaged; the notified body may request further specimens if needed for carrying out the test programme; (5) 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 and/or technical specifications have not been applied or 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. 4. The notified body shall: For the product: (1) examine the technical documentation and supporting evidence to assess the adequacy of the product’s technical design. For the specimen(s): (2) verify that the specimen(s) has (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 and/or technical specifications, as well as the elements which have been designed without applying the relevant provisions of those standards; (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 and/or technical specifications, these have been applied correctly; (4) carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards and/or technical specifications have not been applied, the solutions adopted by the manufacturer meet the corresponding essential requirements of the legislative instrument; (5) agree with the manufacturer on a location where the examinations and tests will be carried out. 5. The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations as provided in point 8, the notified body shall release the content of this report, in full or in part, only with the agreement of the manufacturer. 6. Where the type meets the requirements of this Regulation, the notified body shall issue an EU‑type examination certificate to the manufacturer. This certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the relevant aspects of the requirements covered by the examination, the conditions (if any) for its validity, and the data necessary for the identification of the approved type. The certificate may have one or more annexes attached to it. The EU certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products with the examined type to be evaluated and to allow for in service control. Where the type does not satisfy the applicable requirements of this Regulation, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. 7. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicates that the approved type may no longer comply with the applicable requirements of this Regulation, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the product’s conformity with the essential requirements of this Regulation or the conditions for the certificate’s validity. Such modifications shall require additional approval and attached to the original EU-type examination certificate. 8. Each notified body shall inform its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of certificates and/or any additions thereto refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the 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 a reasoned 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 for 10 years after the product has been assessed or until the validity of the certificate expires. 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 product has been placed on the market. 10. The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate. **Module C** **Conformity to type based on internal production control** 1. Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the applicable requirements of this Regulation. 2. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with the approved type described in the EU-type examination certificate and with the applicable requirements set out in Parts [1](#_DxCrossRefBm1295819208) to [6](#_DxCrossRefBm1295819348), [16](#_DxCrossRefBm1295819115) and [17](#_DxCrossRefBm1295819122). 3. CE marking and EU declaration of conformity (1) The manufacturer shall affix the CE marking and, when relevant, the UA class identification label in accordance with Articles [15](#_DxCrossRefBm1295819364) and [16](#_DxCrossRefBm1295819365) of this Regulation to each product that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements set out in Parts [1](#_DxCrossRefBm1295819208) to [6](#_DxCrossRefBm1295819348), [16](#_DxCrossRefBm1295819115) and [17](#_DxCrossRefBm1295819122). (2) The manufacturer shall draw up a written EU declaration of conformity for each product type and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The EU declaration of conformity shall clearly identify the product type for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. 4. Authorised representative The manufacturer’s obligations set out in point 3 may be fulfilled by their authorised representative, on their behalf and under their responsibility, provided that this is specified in the mandate.