Article 19, Obligations of importers, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)
1. Importers shall place on the Union market only EHR systems which are in conformity with the essential requirements laid down in Annex II.
2. Before making an EHR system available on the market, importers shall ensure that:
(a) the manufacturer has drawn up the technical documentation and 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.
3. Importers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted in a document accompanying the EHR system.
4. Importers 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.
5. Where an importer considers or has reason to believe that an EHR system is not in conformity with the essential requirements in Annex II, it shall not make that system available on the market until that system has been brought into conformity. The importer shall inform without undue delay the manufacturer of such EHR system and the market surveillance authorities of the Member State in which it made the EHR system available, to that effect.
6. Importers shall keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities for the period referred to in Article 17(3) and ensure that the technical documentation can be made available to those authorities, upon request.
7. Importers 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 in the official language of the Member State where the market surveillance authority is located. 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.