+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 3 Conformity of the harmonised software components of EHR systems

1. Overview

Summary	Regulation
Article 36 Common specifications
Article 37 Technical documentation
Article 38 Information sheet accompanying the EHR system
Article 39 EU declaration of conformity
Article 40 European digital testing environment
Article 41 CE marking of conformity
Article 42 National requirements and reporting to the Commission

Requirements
Source	Requirement

Standards
Source	Requirement

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