General information for EU member state countries that require additional regulatory processes.

As a member state of the European Union, medical devices and IVD devices are regulated according to the relevant EU directives:

The Medical Device Directive 93/42 EEC
The In Vitro Device Directive 98/79/EC
The Active Implantable Medical Device Directive 90/385/EEC.
 
However, in this country, devices that have been CE marked under any one of these directives ARE required to go through additional registration or regulatory processes in order to be receive market clearance. Those requirements include product registration with the local Ministry of Health.

Those requirements are (Feb 2011) Product registration with the DIMDI (Local German Competent Authority): 
According to paragraph 25 of the German Medizinproduktegesetz (MPG, English Translation: act on medical devices) all device manufacturers with a place of business in Germany have to notify the responsible authority before placing a device on the market.  Notifications are performed via the online DIMDI database system.

We can assist you to comply with any additional requirements.

Please fill in the following form and submit your inquiry or discuss it with one of our online specialists.  Let's get your products registered in Germany!

(*) German Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.