German Regulatory Approval Process

The approval process is following the EU legislation (clinical trial directive 2001/20 EC), including the German Medicinal Drug Law. Clinical trials in Germany have to be approved by the respective competent federal higher authority, either the BfArM or the PEI depending on the type of product.

Clinical trial start-up time: 4 months

German Pre-Market Regulatory Process

In accordance to German Decrees, it is important to follow with the many ordinances and regulations in order to stay in compliance with the German Authorities. It is necessary to to submit to the Competent Authorities(BfArM) and MEC of the leading site in parallel via the DIMDI website.

German Post-Market Regulatory Process

The Applicable regulation for medical devices expands into MPKPV 7 procedures for clinical trials as well as performance evaluations with medical devices with low safety risk. In order to initiate the Exemption procedure, strict adherence to a request process via the DIMDI website.

Investigators and Sites

Germany hosts around 2,000 hospitals and 340,000 physicians of whom two-thirds are specialists, and provides one of the highest standards of treatment and diagnostic procedures. Hospitals and clinics are usually very well organized and so to fulfill the strictest national requirements of clinical research.