EHDS, Article 31, DE

1. Prior to making an EHR system available on the Union market, a manufacturer of an EHR system established outside of the Union shall, by written mandate, appoint an authorised representative which is established in the Union.

2. An authorised representative shall perform the tasks specified in the mandate agreed with the manufacturer. The mandate shall allow the authorised representative to do at least the following:

(a)

keep the EU declaration of conformity and the technical documentation referred to in Article 37 at the disposal of market surveillance authorities for the period referred to in Article 30(3);

(b)

further to a reasoned request from a market surveillance authority, provide authorities of the Member State concerned with a copy of the mandate and all the information and documentation necessary to demonstrate the conformity of an EHR system with the essential requirements laid down in Annex II as well as the common specifications referred to in Article 36;

(c)

inform without undue delay the manufacturer if the authorised representative has reason to believe that an EHR system is no longer in conformity with the essential requirements laid down in Annex II;

(d)

inform without undue delay the manufacturer about any complaint received from consumers or professional users;

(e)

cooperate with the market surveillance authorities, at their request, on any corrective action taken in relation to the EHR systems covered by their mandate;

(f)

terminate the mandate if the manufacturer does not comply with its obligations under this Regulation;

Official source

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