anx_VIII__table__8

| 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.

← anx_VIII__table__7 · All articles · anx_VIII__table__9 →

Source: EUR-Lex CELLAR · retrieved 2026-09-04 · Text as adopted (Official Journal); later amendments are not incorporated in this text.