The contact point within the meaning of Article 62(4)(g) of Regulation (EU) 2017/745 or of Article 58(5)(g) of Regulation (EU) 2017/746 shall be established at the higher federal authority competent under section 85.
Die Kontaktstelle im Sinne des Artikels 62 Absatz 4 Buchstabe g der Verordnung (EU) 2017/745 oder des Artikels 58 Absatz 5 Buchstabe g der Verordnung (EU) 2017/746 ist bei der nach § 85 zuständigen Bundesoberbehörde einzurichten.
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.