European Health Data Space Regulation
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Table of Contents
Chapter I – General provisions
Chapter II – Primary use
Chapter III – Ehr systems and wellness applications
Chapter IV – Secondary use
Chapter V – Additional actions
Chapter VI – European governance and coordination
Chapter VII – Delegation of powers and committee procedure
Chapter VIII – Miscellaneous
Chapter IX – Deferred application, transitional and final provisions
Recitals (115)
Annexes
Annex IV
EU declaration of conformity
The EU declaration of conformity for the harmonised software components of an EHR system shall contain all of the following information:
1. The name of the EHR system, version and any additional unambiguous reference allowing identification of the EHR system.
2. Name and address of the manufacturer or, where applicable, its authorised representative.
3. A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer.
4. A statement that the EHR system in question is in conformity with the provisions laid down in Chapter III and, if applicable, with any other relevant Union law that provides for the issuing of an EU declaration of conformity, complemented by the result from the testing environment mentioned in Article 40.
5. References to any relevant harmonised standards used and in relation to which conformity is declared.
6. References to any common specifications used and in relation to which conformity is declared.
7. Place and date of issue of the declaration, signature plus name and function of the person who signed and, if applicable, an indication of the person on whose behalf it was signed.
8. Where applicable, additional information.