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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.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.