Germany’s pharma, medtech and digital-health rules are written in German, and official English versions are rare or out of date. We publish working English translations of the provisions that decide market access — side by side with the current German text.
EU law that applies directly in Germany — MDR, IVDR, the Clinical Trials Regulation and the HTA Regulation — is available in English on EUR-Lex; our guides link to it where relevant.
Free to read and link. Cite as: “BCA Unternehmensberatung, English translation of § [n] SGB V, bcaun.de/en/law-library”. Every subsection has its own anchor link.
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, last amended by Article 2 of the Act of 6 October 2026 (BGBl. 2026 I No. 289). Where German statutes use “soll”, “shall” denotes an obligation that admits exceptions in atypical cases. Not legal advice.