Article 20, Obligations of distributors, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)
1. Before making an EHR system available on the market, distributors shall verify that:
(a) the manufacturer has drawn up the EU declaration of conformity;
(b) the EHR system bears the CE marking of conformity;
(c) the EHR system is accompanied by the information sheet referred to in Article 25 and appropriate instructions for use;
(d) where applicable, the importer has complied with the requirements set out in Article 19(3).
2. Distributors shall ensure that, while an EHR system is under their responsibility, the EHR system is not altered in such a way that its conformity with the essential requirements laid down in Annex II is jeopardised.
3. Where a distributor considers or has reason to believe that an EHR system is not in conformity with the essential requirements laid down in Annex II, it shall not make the EHR system available on the market until it has been brought into conformity. Furthermore, the distributor shall inform without undue delay the manufacturer or the importer, as well as the market surveillance authorities of the Member states where the EHR system has been made available on the market, to that effect.
4. Distributors shall, further to a reasoned request from a market surveillance authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system. They shall cooperate with that authority, at its request, on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II.