EHDS, Article 34, SE

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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Geographical article agents

Source: NovaCopilot