Article 24, Technical documentation, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)
1. The technical documentation shall be drawn up before the EHR system is placed on the market or put into service and shall be kept up-to-date.
2. The technical documentation shall be drawn up in such a way as to demonstrate that the EHR system complies with the essential requirements laid down in Annex II and provide market surveillance authorities with all the necessary information to assess the conformity of the EHR system with those requirements. It shall contain, at a minimum, the elements set out in Annex III.
3. The technical documentation shall be drawn up in one of the official languages of the Union. Following a reasoned request from the market surveillance authority of a Member State, the manufacturer shall provide a translation of the relevant parts of the technical documentation into the official language of that Member State.
4. When a market surveillance authority requests the technical documentation or a translation of parts thereof from a manufacturer, it shall set a deadline of 30 days for receipt of such documentation or translation, unless a shorter deadline is justified because of a serious and immediate risk. If the manufacturer does not comply with the requirements of paragraphs 1, 2 and 3, the market surveillance authority may require it to have a test performed by an independent body at its own expense within a specified period in order to verify the conformity with the essential requirements laid down in Annex II and the common specifications referred to in Article 23.