(1) By way of derogation from section 10 subsection (1), the manufacturer shall, in order to demonstrate the positive care effects specified under section 9 subsection (1), submit a prospective comparative study if no suitable data are available that would allow a meaningful retrospective comparison and, in particular, if sufficient comparability of the populations cannot be achieved.
(1) Abweichend von § 10 Absatz 1 legt der Hersteller zum Nachweis der nach § 9 Absatz 1 angegebenen positiven Versorgungseffekte eine prospektive Vergleichsstudie vor, wenn keine geeigneten Daten vorliegen, die einen aussagekräftigen retrospektiven Vergleich ermöglichen und insbesondere keine ausreichende Vergleichbarkeit der Populationen erreicht werden kann.
(2) Section 10 subsections (3) to (7) shall apply mutatis mutandis.
(2) § 10 Absatz 3 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.