EHDS
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
EHDS Article 31. Authorised representatives
- 1.Prior to making an EHR system available on the Union market, a manufacturer of an EHR system established outside of the Union shall, by written mandate, appoint an authorised representative which is established in the Union.
- 2.An authorised representative shall perform the tasks specified in the mandate agreed with the manufacturer. The mandate shall allow the authorised representative to do at least the following:
- (a)keep the EU declaration of conformity and the technical documentation referred to in Article 37 at the disposal of market surveillance authorities for the period referred to in Article 30(3);
- (b)further to a reasoned request from a market surveillance authority, provide authorities of the Member State concerned with a copy of the mandate and all the information and documentation necessary to demonstrate the conformity of an EHR system with the essential requirements laid down in Annex II as well as the common specifications referred to in Article 36;
- (c)inform without undue delay the manufacturer if the authorised representative has reason to believe that an EHR system is no longer in conformity with the essential requirements laid down in Annex II;
- (d)inform without undue delay the manufacturer about any complaint received from consumers or professional users;
- (e)cooperate with the market surveillance authorities, at their request, on any corrective action taken in relation to the EHR systems covered by their mandate;
- (f)terminate the mandate if the manufacturer does not comply with its obligations under this Regulation;
- (g)ensure that the technical documentation referred to in Article 37 can be made available to relevant authorities, upon request.
- 3.In the event of a change of the authorised representative, the detailed arrangements for such change shall address at least the following:
- (a)the date of termination of the mandate of the outgoing authorised representative and the date of the beginning of the mandate of the incoming authorised representative;
- (b)the transfer of documents, including confidentiality aspects and property rights.
- 4.Where the manufacturer is established outside the Union and has not complied with the obligations laid down in Article 30, the authorised representative shall be jointly and severally liable for non-compliance with this Regulation on the same basis as the manufacturer.