+Article 37 2

Article 37 2

2.   The technical documentation referred to in paragraph 1 of this Article shall demonstrate that the EHR system complies with the essential requirements laid down in Annex II and provide market surveillance authorities with all the necessary information to assess the conformity of the EHR system with those requirements. That technical documentation shall contain, as a minimum, the elements set out in Annex III and a reference to the results obtained from a European digital testing environment referred to in Article 40.

1. Overview

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Summary Regulation

1.1 References

1.2 Identified Requirements

1.3 Related Standards

2. Identified Requirements

Requirements
Source Requirement

3. Related Standards

Standards
Source Requirement