Article 17, Obligations of manufacturers of EHR systems, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)
Obligations of manufacturers of EHR systems.
1. Manufacturers of EHR systems shall:
(a) ensure that their EHR systems are in conformity with the essential requirements laid down in Annex II and with the common specifications in accordance with Article 23;
(b) draw up the technical documentation of their EHR systems in accordance with Article 24;
(c) ensure that their EHR systems are accompanied, free of charge for the user, by the information sheet provided for in Article 25 and clear and complete instructions for use;
(d) draw up an EU declaration of conformity as referred to in Article 26;
(e) affix the CE marking in accordance with Article 27;
(f) comply with the registration obligations in Article 32;
(g) take without undue delay any necessary corrective action in respect of their EHR systems which are not in conformity with the essential requirements laid down in Annex II, or recall or withdraw such systems;
(h) inform the distributors of their EHR systems and, where applicable, the authorised representative and importers of any corrective action, recall or withdrawal;
(i) inform the market surveillance authorities of the Member States in which they made their EHR systems available or put them into service of the non-conformity and of any corrective action taken;
(j) upon request of a market surveillance authority, provide it with all the information and documentation necessary to demonstrate the conformity of their EHR system with the essential requirements laid down in Annex II.
(k) cooperate with market surveillance authorities, at their request, on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II.
2. Manufacturers of EHR systems shall ensure that procedures are in place to ensure that the design, development and deployment of an EHR system continues to comply with the essential requirements laid down in Annex II and the common specifications referred to in Article 23. Changes in EHR system design or characteristics shall be adequately taken into account and reflected in the technical documentation.
3. Manufacturers of EHR systems shall keep the technical documentation and the EU declaration of conformity for 10 years after the last EHR system covered by the EU declaration of conformity has been placed on the market.