art_45__para_2

2. Where the manufacturer of the EHR system concerned, its authorised representative or any other relevant economic operator does not take adequate corrective action within a reasonable period, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the EHR system from being made available on the market of their Member States, or to recall or withdraw the EHR system from that market. 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: failure of the EHR system to meet the essential requirements set out in Annex II; shortcomings regarding the common specifications referred to in Article 36.

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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.