2. Before making an EHR system available on the market, importers shall ensure that:
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(a)
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the manufacturer has drawn up the technical documentation referred to in Article 37 and the EU declaration of conformity;
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(b)
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the manufacturer is identified and an authorised representative has been appointed in accordance with Article 31;
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(c)
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the EHR system bears the CE marking of conformity referred to in Article 41 after the conformity assessment procedure has been completed;
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(d)
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the EHR system is accompanied by the information sheet referred to in Article 38 with clear and complete instructions for use, including for its maintenance, in accessible formats.
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