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
Annex IV. EU declaration of conformity
The EU declaration of conformity for the harmonised software components of an EHR system shall contain all of the following information:
- (1)
The name of the EHR system, version and any additional unambiguous reference allowing identification of the EHR system.
- (2)
Name and address of the manufacturer or, where applicable, its authorised representative.
- (3)
A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer.
- (4)
A statement that the EHR system in question is in conformity with the provisions laid down in Chapter III and, if applicable, with any other relevant Union law that provides for the issuing of an EU declaration of conformity, complemented by the result from the testing environment mentioned in Article 40.
- (5)
References to any relevant harmonised standards used and in relation to which conformity is declared.
- (6)
References to any common specifications used and in relation to which conformity is declared.
- (7)
Place and date of issue of the declaration, signature plus name and function of the person who signed and, if applicable, an indication of the person on whose behalf it was signed.
- (8)
Where applicable, additional information.