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1. Internal control is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points 2, 3 and 4 of this Part, and ensures and declares on its sole responsibility that the products with digital elements satisfy all the essential cybersecurity requirements set out in Part I of Annex I and the manufacturer meets the essential cybersecurity requirements set out in Part II of Annex I.

2. The manufacturer shall draw up the technical documentation described in Annex VII.

3. Design, development, production and vulnerability handling of products with digital elements The manufacturer shall take all measures necessary so that the design, development, production and vulnerability handling processes and their monitoring ensure compliance of the manufactured or developed products with digital elements and of the processes put in place by the manufacturer with the essential cybersecurity requirements set out in Parts I and II of Annex I.

4. Conformity marking and declaration of conformity

4.1. The manufacturer shall affix the CE marking to each individual product with digital elements that satisfies the applicable requirements set out in this Regulation.

4.2. The manufacturer shall draw up a written EU declaration of conformity for each product with digital elements in accordance with Article 28 and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product with digital elements has been placed on the market or for the support period, whichever is longer. The EU declaration of conformity shall identify the product with digital elements 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.

5. Authorised representatives The manufacturer’s obligations set out in point 4 may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that the relevant obligations are specified in the mandate. Part II EU-type examination (based on module B)

1. EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design and development of a product with digital elements and the vulnerability handling processes put in place by the manufacturer, and attests that a product with digital elements meets the essential cybersecurity requirements set out in Part I of Annex I and that the manufacturer meets the essential cybersecurity requirements set out in Part II of Annex I.

2. EU-type examination shall be carried out by assessing the adequacy of the technical design and development of the product with digital elements through the examination of the technical documentation and supporting evidence referred to in point 3, and the examination of specimens 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 its choice. The application shall include: 3.1. the name and address of the manufacturer and, if the application is lodged by the authorised representative, the name and address of that authorised representative;

3.2. a written declaration that the same application has not been lodged with any other notified body; 3.3. the technical documentation, which shall make it possible to assess the conformity of the product with digital elements with the applicable essential cybersecurity requirements as set out in Part I of Annex I and the manufacturer’s vulnerability handling processes set out in Part II of Annex I and shall include an adequate analysis and assessment of the risks. The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product with digital elements. The technical documentation shall contain, wherever applicable, at least the elements set out in Annex VII;

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

4. The notified body shall: 4.1. examine the technical documentation and supporting evidence to assess the adequacy of the technical design and development of the product with digital elements with the essential cybersecurity requirements set out in Part I of Annex I and of the vulnerability handling processes put in place by the manufacturer with the essential cybersecurity requirements set out in Part II of Annex I;

4.2. verify that specimens have been developed or manufactured in conformity with the technical documentation, and identify the elements which have been designed and developed in accordance with the applicable provisions of the relevant harmonised standards or technical specifications, as well as the elements which have been designed and developed without applying the relevant provisions of those standards; 4.3. carry out appropriate examinations and tests, or have them carried out, to check that, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards or technical specifications for the requirements set out in Annex I, they have been applied correctly; 4.4. carry out appropriate examinations and tests, or have them carried out, to check that, where the solutions in the relevant harmonised standards or technical specifications for the requirements set out in Annex I have not been applied, the solutions adopted by the manufacturer meet the corresponding essential cybersecurity requirements; 4.5. 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 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.

6. Where the type and the vulnerability handling processes meet the essential cybersecurity requirements set out in Annex I, 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 and the necessary data for identification of the approved type and vulnerability handling processes. The certificate may have one or more annexes attached. The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured or developed products with digital elements with the examined type and vulnerability handling processes to be evaluated and to allow for in-service control.

Where the type and the vulnerability handling processes do not satisfy the applicable essential cybersecurity requirements set out in Annex I, 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 indicate that the approved type and the vulnerability handling processes may no longer comply with the applicable essential cybersecurity requirements set out in Annex I, 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 and the vulnerability handling processes that may affect the conformity with the essential cybersecurity requirements set out in Annex I, 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.

8. The notified body shall carry out periodic audits to ensure that the vulnerability handling processes as set out in Part II of Annex I are implemented adequately.

9. Each notified body shall inform its notifying authorities concerning the EU-type examination certificates and any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and any additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and 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 any 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 the certificate.

10. 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 with digital elements has been placed on the market or for the support period, whichever is longer.