sec_7_4_1_1__para__4
The technical documentation must be made available to the market surveillance authority within a reasonable period of time, in response to a reasoned request (Article R2(9) of Annex I to Decision No 768/2008). The authority cannot request it systematically. In general, it can be requested during checks made for market surveillance purposes, or when there are grounds for concern that a product does not offer the level of protection required in all respects.
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Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.