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 39. EU declaration of conformity
- 1.The EU declaration of conformity referred to in Article 30(1), point (e), shall state that the manufacturer of an EHR system has demonstrated that the essential requirements laid down in Annex II have been fulfilled.
- 2.Where an EHR system is subject to other Union legal acts in respect of aspects not covered by this Regulation, which also require an EU declaration of conformity by the manufacturer in which it is stated that the fulfilment of the requirements of those legal acts has been demonstrated, a single EU declaration of conformity shall be drawn up in respect of all Union legal acts applicable to the EHR system. That EU declaration of conformity shall contain all the information required for the identification of the Union legal acts to which it relates.
- 3.The EU declaration of conformity shall contain the information set out in Annex IV and shall be translated into one or more official Union languages determined by the Member States in which the EHR system is made available.
- 4.Where an EU declaration of conformity is drawn up in a digital format, it shall be made accessible online for the expected lifetime of the EHR system and, in any event, for at least 10 years from the placing on the market or the putting into service of the EHR system.
- 5.By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the harmonised software components of the EHR system with the requirements laid down in this Regulation when it is placed on the market or put into service.
- 6.The Commission shall publish a standard uniform template for the EU declaration of conformity and make it available in a digital format in all official languages of the Union.
Relevant Recitals for this Article
This Regulation imposes a mandatory conformity self-assessment scheme for the harmonised software components of EHR systems to ensure that EHR systems placed on the Union market are able to exchange data in the European electronic health record exchange format and that they have the required logging capabilities. That mandatory conformity self-assessment, which would be in the form of an EU declaration of conformity by the manufacturer, should ensure that those requirements are fulfilled in a proportionate way, while avoiding an undue burden on Member States and manufacturers.