The other clinical investigation shall not be continued where the opinion of the competent ethics committee has been withdrawn or revoked.
Die sonstige klinische Prüfung darf nicht fortgesetzt werden, wenn die Stellungnahme der zuständigen Ethik-Kommission zurückgenommen oder widerrufen wurde.
Background: Running a clinical trial in Germany · MDR vs IVDR in Germany · EU Authorised Representative and PRRC. We explain what this provision means for your launch, price and timeline — fixed price, in writing.
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.