- Clinical investigation: 3000 €
- Substantial amendment: 500 €
Clinical investigations on a medical device submitted together with a related medicinal product by the same applicant. In this case, the total fee for a clinical investigation on medical devices plus 35 % of the set fee for clinical trials on medicinal products (3000 € Phase I-III, 1500€ Phase IV) will be charged.
NB: From 01.01.2016, new fees for non-commercial (academic) studies apply:
20% of regular fees for notification of a clinical investigation of a medical device or a performance test
validation of an IVD (one-time charge!)
No fees for substantial amendments or inspections are charged.
Reduced fees are charged
Latest version of “BASG Gebührentarifverordnung gemäß Gesundheits- und Ernährungssicherheitsgesetz GESG" (Regulation on Fees), published on the BASG/AGES website (also available in English).
BASG Gebührentarifverordnung gemäß Gesundheits- und Ernährungssicherheitsgesetz GESG (de)/ Regulation on Fees (en);
Waiver for academic studies: Art 1a. (2)