Articles of the European Health Data Space (EHDS), Article 28, Market surveillance authorities



Article 28, Market surveillance authorities, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)

1. Regulation (EU) 2019/1020 shall apply to EHR systems covered by Chapter III of this Regulation.


2. Member States shall designate the market surveillance authority or authorities responsible for the implementation of this Chapter. They shall entrust their market surveillance authorities with the powers, resources, equipment and knowledge necessary for the proper performance of their tasks pursuant to this Regulation. Member States shall communicate the identity of the market surveillance authorities to the Commission which shall publish a list of those authorities.


3. Market surveillance authorities designated pursuant to this Article may be the digital health authorities designated pursuant to Article 10. Where a digital health authority carries out tasks of market surveillance authority, any conflict of interest shall be avoided.


4. Market surveillance authorities shall report to the Commission on a regular basis the outcomes of relevant market surveillance activities.


5. The market surveillance authorities of the Member States shall cooperate with each other and with the Commission. The Commission shall provide for the organisation of exchanges of information necessary to that effect.


6. For medical devices or high-risk AI systems referred to in Article 14 (3) and (4), the responsible authorities for market surveillance shall be those referred to in Article 93 of Regulation (EU) 2017/745 or Article 59 of Regulation […] [AI act COM/2021/206 final], as applicable.