Since 1 February 2021, manufacturers of medical devices with electrical components who sell their products in Germany have had the opportunity to submit their annual statistics report for the calendar year 2020 in the ear portal (stiftung elektro-altgeräte register).
The annual statistics report for the calendar year 2020 is legally binding and must be entered in full in the ear portal by 30.04.2021 at the latest.
Categories of medical devices
Medical devices belong to either:
- Category 2 (medical) ‘Screens, monitors and devices containing screens with a surface area of more than 100 cm²’
- Category 3 (medical) ‘Lamps’,
- Category 4 (medical) ‘Devices where at least one of the external dimensions exceeds 50 centimetres (large devices)’ or
- Category 5 (medical) ‘Devices in which none of the external dimensions exceeds 50 centimetres (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 above-mentioned categories in the course of system maintenance. What has remained is the subdivision of device types into
- b2c (possible use in the private sector) and
- b2b (electrical appliances for commercial use only)
and the corresponding substantiation.
Medical devices and in-vitro diagnostics that are likely to become infectious before the end of their service life, as well as active implants, are not subject to registration with the ear-foundation.
f you place b2b / b2c electrical medical devices on the market in Germany and are not yet registered with the ear-foundation you can find further information on the ear-foundation's website. You can find access to the ear portal on the website: https://www.ear-system.de/ear-portal/
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