The technical documentation referred to in Article 37 shall contain at least the following
information, as applicable to the harmonised software components of an EHR system in the
relevant EHR system:
1. A detailed description of the EHR system including:
- (a) its intended purpose, and the date and version of the EHR system;
- (b) the categories of personal electronic health data that the EHR system has been
designed to process;
- (c) how the EHR system interacts or can be used to interact with hardware or
software that is not part of the EHR system itself;
- (d) the versions of relevant software or firmware and any requirement related to
version update;
- (e) the description of all forms in which the EHR system is placed on the market
or put into service;
- (f) the description of hardware on which the EHR system is intended to run;
- (g) a description of the system architecture explaining how software components
build on or feed into each other and integrate into the overall processing,
including, where appropriate, labelled pictorial representations (e.g. diagrams
and drawings), clearly indicating key parts or software components and
including sufficient explanation to understand the drawings and diagrams;
- (h) the technical specifications, such as features, dimensions and performance
attributes, of the EHR system and any variants or configurations and
accessories that would typically appear in the product specification made
available to the user, for example in brochures, catalogues and similar
publications, including a detailed description of the data structures, storage and
input/output of data;
- (i) a description of any change made to the system throughout its lifecycle;
- (j) the instructions for use for the user and, where applicable, installation
instructions.
2. A detailed description of the system in place to evaluate the EHR system
performance, where applicable.
3. The references to any common specification used in accordance with Article 36 and
in relation to which conformity is declared.
4. The results and critical analyses of all verifications and validation tests undertaken to
demonstrate conformity of the EHR system with the requirements laid down in
Chapter III, in particular the applicable essential requirements.
5. A copy of the information sheet referred to in Article 38.
6. A copy of the EU declaration of conformity.
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