Article 45

Handling of non-compliance

In short: Details how the surveillance authority should deal with non-compliance of systems.

1. Where a market surveillance authority makes a finding of non-compliance, it shall require the manufacturer of the EHR system concerned, its authorised representative and all other relevant economic operators to take, by a specific deadline, adequate corrective action to bring the EHR system into conformity. Such findings of non-compliance include, but are not limited to, the following:
   • (a) the EHR system is not in conformity with essential requirements laid down in Annex II or with the common specifications referred to in Article 36;
   • (b) the technical documentation is not available, not complete or not in accordance with Article 37;
   • (c) the EU declaration of conformity has not been drawn up or has not been drawn up correctly in accordance with Article 39;
   • (d) the CE marking of conformity has been affixed in breach of Article 41 or has not been affixed;
   • (e) the registration obligations of Article 49 have not been fulfilled.
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:

   • (a) failure of the EHR system to meet the essential requirements set out in Annex II;
   • (b) shortcomings regarding the common specifications referred to in Article 36.
3. Market surveillance authorities other than the market surveillance authorities initiating the procedure under this Article shall inform without delay the Commission and the other Member States' market surveillance authorities of any measures adopted, of any additional information at their disposal relating to the non-compliance of the EHR system concerned and, in the event of disagreement with the adopted national measure, of their objections.
4. Where, within three months of receipt of the information referred to in the second subparagraph of paragraph 2, no objection has been raised by either a market surveillance authority from another Member State or the Commission in respect of a provisional measure taken by a market surveillance authority, that measure shall be deemed justified.
5. Where the non-compliance referred to in paragraph 1 persists, the market surveillance authority concerned shall take all appropriate measures to prohibit or restrict the EHR system from being made available on the market or ensure that it is recalled or withdrawn from the market.

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