Data & Privacy
- Data Act
- Data Governance Act
- EHDS
- ePrivacy Directive
- GDPR
AI & Trust
- Artificial Intelligence Act
- Product Liability Directive
Cybersecurity
- Cyber Resilience Act
- Cybersecurity Act
- DORA
- NIS2
Digital Services & Media
- Digital Markets Act
- Digital Services Act
- European Media Freedom Act
European Health Data Space Regulation
- Recitals
CHAPTER I
GENERAL PROVISIONSArticles 1 — 2
CHAPTER II
PRIMARY USEArticles 3 — 24
CHAPTER III
EHR SYSTEMS AND WELLNESS APPLICATIONSArticles 25 — 49
CHAPTER IV
SECONDARY USEArticles 50 — 81
CHAPTER V
ADDITIONAL ACTIONSArticles 82 — 91
CHAPTER VI
EUROPEAN GOVERNANCE AND COORDINATIONArticles 92 — 96
CHAPTER VII
DELEGATION OF POWERS AND COMMITTEE PROCEDUREArticles 97 — 98
CHAPTER VIII
MISCELLANEOUSArticles 99 — 104
CHAPTER IX
DEFERRED APPLICATION, TRANSITIONAL AND FINAL PROVISIONSArticles 105 — 105
ANNEXES
EHDS Article 43. Market surveillance authorities
- 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.
Relevant Recitals for this Article
In order to ensure there is appropriate and effective enforcement of the requirements and obligations laid down in this Regulation, the system of market surveillance and compliance of products established by Regulation (EU) 2019/1020 of the European Parliament and of the Council should apply. Depending on the organisation defined at national level, such market surveillance activities could be carried out by the digital health authorities ensuring the proper implementation of Chapter II of this Regulation or by a separate market surveillance authority responsible for EHR systems. While designating digital health authorities as market surveillance authorities could have significant practical advantages for the implementation of health and care, any conflicts of interest should be avoided, for instance by separating different tasks.
The staff of market surveillance authorities should have no direct or indirect economic, financial or personal conflicts of interest that might be considered prejudicial to their independence and, in particular, they should not be in a situation that could, directly or indirectly, affect the impartiality of their professional conduct. Member States should determine and publish the selection procedure for market surveillance authorities. They should ensure that the procedure is transparent and does not allow conflicts of interest.