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 41. CE marking of conformity
- 1.The CE marking of conformity shall be affixed visibly, legibly and indelibly to the accompanying documents of the EHR system and, where applicable, to the packaging of the EHR system.
- 2.The CE marking of conformity shall be affixed before placing the EHR system on the market.
- 3.The CE marking of conformity shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
Relevant Recitals for this Article
Manufacturers should affix in the accompanying documents of the EHR system, and where applicable on its packaging, a CE marking of conformity indicating that the EHR system is in conformity with this Regulation and, in respect of aspects not covered by this Regulation, with other applicable Union law which also requires the affixing of such marking. Member States should build upon existing mechanisms to ensure the correct application of the provisions on the CE marking of conformity under relevant Union law and should take appropriate action in the event of improper use of that marking.