REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Germany, devices are regulated by the The Federal Institute for Drugs and Medical Devices (BfArM) and The German Institute of Medical Documentation and Information (DIMDI), an authority within the German Federal Ministry of Health.
CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III.
TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.
LICENSE VALIDITY: Licenses issued in the EU are valid for five years.
AUTHORIZED REPRESENTATIVE: An authorized representative anywhere in the European Union is required.
ADDITIONAL INFORMATION: On April 5, 2017, two new Regulations on medical devices were adopted, these entered into force on May 25, 2017 and replaced the existing Directives. The new rules will only apply after a transitional period, namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
For manufacturers who are either in Germany or have their Authorized Representative located in Germany, devices that have been CE-Marked are required to go through additional registration or regulatory processes, including product registration with the DIMDI (the local German competent authority), in order to receive market clearance.