Competent Authorities

The address and contact information of the respective authorities in Germany and the EEA Member States will be provided on the following pages:

Medical devices and In-vitro diagnostics

Medical devices and in-vitro diagnostics may only be put into circulation or operation if they fulfil the fundamental requirements specified in the European Guidelines. The respective authorities are to take part in the notification and approval procedure and can be determined depending on the location of the manufacturer or his authorised representative, and on the product category.

Clinical investigations and performance evaluations

Applications for approval of a clinical investigation (CI) of medical devices or performance evaluations (PE) of in vitro diagnostics must be submitted to the competent authority (BfArM or PEI). The federal state authorities are responsible for the monitoring of all CI/PE, as well as for notification of change and withdrawal for CI/PE that were notified before March 21st, 2010.

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