art_43__para_5

5. Where a manufacturer or another economic operator fails to cooperate with a market surveillance authority or where the information and documentation they have provided is incomplete or incorrect, the market surveillance authority may take all appropriate measures to prohibit or restrict the relevant EHR system from being made available on the market until the manufacturer or the economic operator concerned cooperates or provides complete and correct information, or to recall or withdraw such EHR system from the market.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.