EHDS, Artikkel 43, DE
1. Regulation (EU) 2019/1020 shall apply to EHR systems in relation to the requirements applicable to, and risks posed by, EHR systems covered by this Chapter.
2. Member States shall designate the market surveillance authority or authorities responsible for the implementation of this Chapter. Member States shall entrust their market surveillance authorities with the necessary powers and shall provide them with the human, financial and technical resources, the equipment and the knowledge necessary for the proper performance of their tasks pursuant to this Regulation. Market surveillance authorities shall be empowered to take the market surveillance measures referred to in Article 16 of Regulation (EU) 2019/1020 to enforce the obligations laid down in this Chapter. Member States shall communicate the identity of the market surveillance authorities they designate to the Commission. The Commission and the Member States shall make that information publicly available.
3. Market surveillance authorities designated pursuant to paragraph 2 of this Article may be the same authorities as the digital health authorities designated pursuant to Article 19. Where a digital health authority carries out tasks of a market surveillance authority, Member States shall ensure that any conflicts of interest are avoided.
4. Market surveillance authorities shall report to the Commission on a yearly basis the outcomes of relevant market surveillance activities.
5. Where a manufacturer or another economic operator fails to cooperate with a market surveillance authority or where the information and documentation they have provided is incomplete or incorrect, the market surveillance authority may take all appropriate measures to prohibit or restrict the relevant EHR system from being made available on the market until the manufacturer or the economic operator concerned cooperates or provides complete and correct information, or to recall or withdraw such EHR system from the market.
6. The market surveillance authorities of the Member States shall cooperate with each other and with the Commission. The Commission shall enable the organisation of exchanges of information necessary for such cooperation.
7. For medical devices, in vitro diagnostic medical devices or high-risk AI systems referred to in Article 27(1) and (2), the responsible authorities for market surveillance shall be those referred to in Article 93 of Regulation (EU) 2017/745, Article 88 of Regulation (EU) 2017/746 or Article 70 of Regulation (EU) 2024/1689, as applicable.
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Source: NovaCopilot