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Digital Health Applications Ordinance · Division 3 · Demonstrating positive care effects
Section 11a

Studies demonstrating the medical benefit of digital health applications of a higher risk class

§ 11a DiGAV · Studien zum Nachweis des medizinischen Nutzens bei digitalen Gesundheitsanwendungen höherer Risikoklasse

Digitale Gesundheitsanwendungen-Verordnung (DiGAV) · German text as of 29 October 2026 · translation edited by Alexander Baranov

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(1) By way of derogation from section 10 subsection (1), the manufacturer shall, in order to demonstrate the medical benefit of digital health applications of a higher risk class, submit a prospective comparative study.

(1) Abweichend von § 10 Absatz 1 legt der Hersteller zum Nachweis des medizinischen Nutzens bei digitalen Gesundheitsanwendungen höherer Risikoklasse eine prospektive Vergleichsstudie vor.

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(2) Section 10 subsections (5) to (7) shall apply mutatis mutandis.

(2) § 10 Absatz 5 bis 7 gilt entsprechend.

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Unofficial translation for information only. Only the German text is legally binding. German text: consolidated version from gesetze-im-internet.de, retrieved 29 October 2026. Where German statutes use “soll”, “shall” denotes an obligation that admits exceptions in atypical cases. Not legal advice.