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:
Systems and procedure packs
The Medical Devices Ordinance and the Ordinance on In Vitro Diagnostic Medical Devices set out requirements and responsibilities for operators in the medical devices supply chain. The following Information sheet outlines the obligations for the assembly and labelling of systems and procedure packs, as well as the associated obligations of economic operators in Switzerland and Liechtenstein.
Rapid tests for SARS-CoV-2 to the general public for their own use (coronavirus self-tests)
01.07.2024
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
Pelvic floor meshes and slings
3D printers and medical device legislation
Compressed air, pressure vessels, pressure equipment
Hypothermia devices (heater cooler units)
08.02.2017
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