art_45__para_2__para

The market surveillance authorities shall inform the Commission and the other Member States’ market surveillance authorities, without delay, of those provisional measures. That information shall include all available details, in particular the data necessary for the identification of the non-compliant EHR system, the origin of that EHR system, the nature of the non-compliance alleged and the risk involved, the nature and duration of the measures taken by the market surveillance authorities and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to any of the following:

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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.