At the end of January, the German Federal Institute for Drugs and Medical Devices (BfArM) and the Federal Ministry of Health (BMG) announced the launch of an Innovation Office. It will be a first port of call for scientists and small companies wishing to develop innovative medical products and who have hitherto had little experience of regulatory matters - whether for diagnostics, therapeutics or medical apps.
In future, they will be able to inform themselves at a very early project stage about the relevant requirements for the approval of their products and when placing them on the market. These may have direct consequences for the next development phase, and can be essential to the success of the project. In the pharmaceutical area, for example, the Innovation Office can point out at an early stage which data should be generated. In the case of medical apps, it can provide information about their possible classification as medical products and the associated regulatory consequences.
The Innovation Office is offering ‘Kick-off Meetings’ as a preliminary to the already established consulting services it provides on scientific and procedural matters.
For further information:
Press release from the BfArM and BMG (only available in German)