DIMDI medicalknowlege, German Institute of Medical Documentation and Information

Institute within the scope of the Federal Ministry of Health (BMG)

page title: DIMDI - Medical Devices - Addresses
webaddress,url: http://www.dimdi.de/en/mpg/adress/index.htm

Addresses of German Authorities

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.

Starting from March 21st 2010, clinical investigations of medical devices and performance evaluations of in vitro diagnostics that are carried out in Germany must be submitted and approved by the competent authority (BfArM or PEI) and approvingly evaluated by an Ethics Committee before they may commence.

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