Articles of the European Health Data Space (EHDS), Article 18, Authorised representatives

Article 18, Authorised representatives, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)

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 received from 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 at the disposal of market surveillance authorities for the period referred to in Article 17(3);

(b) further to a reasoned request from a market surveillance authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of an EHR system with the essential requirements laid down in Annex II;

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