Information on specific medical devices

Product groups without an intended medical purpose in accordance with Annex 1 MedDO

Publications on products specified in Annex 1 MedDO with a medical or non-medical intended purpose, i.e. including dual-use products (e.g. breast implants or injectable products for wrinkle treatment), can be found in the new section on product groups without an intended medical purpose:

Rapid tests for SARS-CoV-2 to the general public for their own use (coronavirus self-tests)


Pelvic floor meshes and slings

3D printers and medical device legislation

Compressed air, pressure vessels, pressure equipment

Hypothermia devices (heater cooler units)

We would like to inform you about new directives on the operation and the surveillance of hypothermia devices (Heater-Cooler Devices / Units) in the operation room:

Link to the information from the FOPH (in German):

In-vitro diagnostics (IVD)

Paclitaxel-coated balloons and paclitaxel-eluting stents


Accessories for medical devices