As of 01.02.2021, manufacturers of medical devices with electrical components who sell their products in Germany have the opportunity to submit their annual statistics notification for the calendar year 2020 in the ear-Portal.
The annual statistics notification for the calendar year 2020 is legally binding and must be completely recorded in the ear portal by 30.04.2021 at the latest.
Categories Electrical Medical Devices
Electrical medical devices belong to either the:
- Category 2 (medical) “Screens, monitors and equipment containing screens with a surface area greater than 100 cm²”,
- Category 3 (medical) “lamps”,
- Category 4 (medical) “devices where at least one of the external dimensions is more than 50 centimeters (large devices)”, or
- Category 5 (medical) “devices where none of the external dimensions exceeds 50 centimeters (small devices)”.
When the register was set up a few years ago, there was a separate category for medical devices, which was merged into the categories mentioned above in the course of system maintenance. What has remained is the subdivision of the device types into
- b2c (possible use in the private sector) and
- b2b (exclusively commercial usable electrical appliances)
and the corresponding approval.
Electrical medical devices and in vitro diagnostic devices that are likely to become infectious before the end of their service life, as well as active implants, are not subject to the obligation to register with the foundation stiftung ear.
If you place electrical medical devices b2c / b2b on the market in Germany and are not already registered with foundation you can find further information on the stifting ear website and access to the ear-portal directly.