+CHAPTER III EHR SYSTEMS AND WELLNESS APPLICATIONS
---+SECTION 1 Scope and general provisions for EHR systems
------+Article 25 Harmonised software components of EHR systems
---------+Article 25 1
---------+Article 25 2
------+Article 26 Placing on the market and putting into service
---------+Article 26 1
---------+Article 26 2
---------+Article 26 3
------+Article 27 Relation to Union law governing medical devices, in vitro diagnostic medical devices and AI systems
---------+Article 27 1
---------+Article 27 2
------+Article 28 Claims
---------+Article 28 (a)
---------+Article 28 (b)
---------+Article 28 (c)
------+Article 29 Procurement, reimbursement and financing
---+SECTION 2 Obligations of economic operators with regard to EHR systems
------+Article 30 Obligations of manufacturers of EHR systems
---------+Article 30 1
---------+Article 30 2
---------+Article 30 3
---------+Article 30 4
---------+Article 30 5
------+Article 31 Authorised representatives
---------+Article 31 1
---------+Article 31 2
---------+Article 31 3
---------+Article 31 4
------+Article 32 Obligations of importers
---------+Article 32 1
---------+Article 32 2
---------+Article 32 3
---------+Article 32 4
---------+Article 32 5
---------+Article 32 6
---------+Article 32 7
---------+Article 32 8
---------+Article 32 9
------+Article 33 Obligations of distributors
---------+Article 33 1
---------+Article 33 2
---------+Article 33 3
---------+Article 33 4
------+Article 34 Cases in which obligations of manufacturers of an EHR system apply to other entities or individuals
---------+Article 34 (a)
---------+Article 34 (b)
---------+Article 34 (c)
------+Article 35 Identification of economic operators
---------+Article 35 (a)
---------+Article 35 (b)
---+SECTION 3 Conformity of the harmonised software components of EHR systems
------+Article 36 Common specifications
---------+Article 36 1
---------+Article 36 2
---------+Article 36 3
---------+Article 36 4
---------+Article 36 5
---------+Article 36 6
------+Article 37 Technical documentation
---------+Article 37 1
---------+Article 37 2
---------+Article 37 3
---------+Article 37 4
------+Article 38 Information sheet accompanying the EHR system
---------+Article 38 1
---------+Article 38 2
---------+Article 38 3
------+Article 39 EU declaration of conformity
---------+Article 39 1
---------+Article 39 2
---------+Article 39 3
---------+Article 39 4
---------+Article 39 5
---------+Article 39 6
------+Article 40 European digital testing environment
---------+Article 40 1
---------+Article 40 2
---------+Article 40 3
---------+Article 40 4
------+Article 41 CE marking of conformity
---------+Article 41 1
---------+Article 41 2
---------+Article 41 3
------+Article 42 National requirements and reporting to the Commission
---------+Article 42 1
---------+Article 42 2
---------+Article 42 3
---+SECTION 4 Market surveillance of EHR systems
------+Article 43 Market surveillance authorities
---------+Article 43 1
---------+Article 43 2
---------+Article 43 3
---------+Article 43 4
---------+Article 43 5
---------+Article 43 6
---------+Article 43 7
------+Article 44 Handling of risks posed by EHR systems and of serious incidents
---------+Article 44 1
---------+Article 44 2
---------+Article 44 3
---------+Article 44 4
---------+Article 44 5
---------+Article 44 6
---------+Article 44 7
---------+Article 44 8
---------+Article 44 9
---------+Article 44 10
------+Article 45 Handling of non-compliance
---------+Article 45 1
---------+Article 45 2
---------+Article 45 3
---------+Article 45 4
---------+Article 45 5
------+Article 46 Union safeguard procedure
---------+Article 46 1
---------+Article 46 2
---+SECTION 5 Other provisions on interoperability
------+Article 47 Labelling of wellness applications
---------+Article 47 1
---------+Article 47 2
---------+Article 47 3
---------+Article 47 4
---------+Article 47 5
---------+Article 47 6
---------+Article 47 7
---------+Article 47 8
---------+Article 47 9
------+Article 48 Interoperability of wellness applications with EHR systems
---------+Article 48 1
---------+Article 48 2
---+SECTION 6 Registration of EHR systems and wellness applications
------+Article 49 EU database for registration of EHR systems and wellness applications
---------+Article 49 1
---------+Article 49 2
---------+Article 49 3
---------+Article 49 4

CHAPTER III EHR SYSTEMS AND WELLNESS APPLICATIONS

CHAPTER III EHR SYSTEMS AND WELLNESS APPLICATIONS

1. Overview

,
SECTION 1 Scope and general provisions for EHR systems SECTION 1 Scope and general provisions for EHR systems
SECTION 2 Obligations of economic operators with regard to EHR systems SECTION 2 Obligations of economic operators with regard to EHR systems
SECTION 3 Conformity of the harmonised software components of EHR systems SECTION 3 Conformity of the harmonised software components of EHR systems
SECTION 4 Market surveillance of EHR systems SECTION 4 Market surveillance of EHR systems
SECTION 5 Other provisions on interoperability SECTION 5 Other provisions on interoperability
SECTION 6 Registration of EHR systems and wellness applications SECTION 6 Registration of EHR systems and wellness applications

1.1 References

1.2 Identified Requirements

1.3 Related Standards

2. Identified Requirements

Requirements

3. Related Standards

Standards
  • Builddate: 05.03.2025 00:00:00 -Doknr: CELEX:32025R0327
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