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Guidance: Clinical Investigation and Performance Evaluation

Starting from March 21, 2010, clinical investigations (CI) for medical devices and performance evaluations (PE) of in vitro diagnostic agents in Germany must be approved by the competent authority (BfArM or PEI) and approvingly evaluated by an Ethics Committee before they may commence (according to §§ 20-24 MPG). The application forms for this purpose have to be submitted online through the German Medical Devices Information System.

Please note, that the entire Medical Devices Information System is in German language.

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You can find important information on the use of the Medical Devices Information System in the general information.


The guidance explain how you can apply for access authorisation (user code and password), how you can get into the MD-Information System and how the notification and application procedures for your adress and a clinical investigation and performance evaluation proceed.