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 49. EU database for registration of EHR systems and wellness applications
- 1.The Commission shall establish and maintain a publicly available EU database with data on EHR systems for which an EU declaration of conformity has been issued pursuant to Article 39 and wellness applications for which a label has been issued pursuant to Article 47 (the ‘EU database for registration of EHR systems and wellness applications’).
- 2.Before placing on the market or putting into service an EHR system referred to in Article 26 or a wellness application referred to in Article 47, the manufacturer of such EHR system or wellness application or, where applicable, its authorised representative shall enter the required data as referred to in paragraph 4 of this Article into the EU database for registration of EHR systems and wellness applications, including, in the case of EHR systems, the results of the assessment referred to in Article 40.
- 3.Medical devices, in vitro diagnostic medical devices or high-risk AI systems referred to in Article 27(1) and (2) of this Regulation shall also be registered in the databases established pursuant to Regulation (EU) 2017/745, (EU) 2017/746 or (EU) 2024/1689, as applicable. In such cases, the data to be entered shall also be forwarded to the EU database for registration of EHR systems and wellness applications.
- 4.The Commission is empowered to adopt delegated acts in accordance with Article 97 to supplement this Regulation by determining the list of required data to be entered into the EU database for registration of EHR systems and wellness applications by the manufacturers of EHR systems and wellness applications pursuant to paragraph 2 of this Article.
Relevant Recitals for this Article
The distribution of information on certified EHR systems and labelled wellness applications is necessary to enable procurers and users of such products to find interoperable solutions for their specific needs. A database of interoperable EHR systems and wellness applications, which do not fall within the scope of Regulations (EU) 2017/745 and (EU) 2024/1689, should therefore be established at Union level, similar to the European database on medical devices (Eudamed) established by Regulation (EU) 2017/745. The objectives of the EU database for registration of EHR systems and wellness applications should be to enhance overall transparency, to avoid multiple reporting requirements and to streamline and facilitate the flow of information. For medical devices and AI systems, the registration should be maintained under the existing databases established, respectively, under Regulations (EU) 2017/745 and (EU) 2024/1689, but the compliance with interoperability requirements should be indicated by manufacturers when they claim such compliance, in order to provide information to procurers.