anx_VIII__table__26

| 6. | The manufacturer shall, for a period ending at least 10 years after the product with digital elements has been placed on the market or for the support period, whichever is longer, keep at the disposal of the national authorities: (a) the technical documentation referred to in point 3.1; (b) the documentation concerning the quality system referred to in point 3.1; (c) the change referred to in point 3.5, as approved; (d) the decisions and reports of the notified body referred to in points 3.5 and 4.3.

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