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EHDS

EHDS Article 34. Cases in which obligations of manufacturers of an EHR system apply to other entities or individuals

  • An importer, distributor or user shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations laid down in Article 30 where they:
    • (a)
      make an EHR system available on the market under their own name or trademark;
    • (b)
      modify an EHR system already placed on the market in such a way that conformity with the applicable requirements might be affected; or
    • (c)
      modify an EHR system in such a way that it leads to changes in the intended purpose declared by the manufacturer.

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