Annex III

Technical documentation

In short: Defines the documentation requirements of EHR systems.

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 updates
   • (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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