Breast augmentation
PIP breast implants
Link to the European SCENIHR report:
Link to information from the UK authority MHRA:
Link to information from the French authority ANSM:
Link to information from Swissmedic:
3D printers and medical device legislation
Compressed air, pressure vessels, pressure equipment
Medical devices and pressure equipment regulations (PDF, 81 kB, 22.06.2017)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):
21.06.2016
Update on measures for improved patient safety in cardiac surgery
On 14 July 2014, the FOPH, in conjunction with Swissmedic, published safety measures in response to observed cases of Mycobacterium chimaera infection during the use of hypothermia systems (heater-cooler units, HCUs) in cardiac surgery. We would now like to bring you up to date on recent recommendations concerning the use of hypothermia systems in cardiac surgery:
14.07.2014
Press release
Hip implants
Metal-on-metal hip implants (MoM):
as at 23 January 2015
The safety of metal-on-metal hip implants has recently been called into question by several parties. A group of experts (SCENIHR – Scientific Committee on Emerging and Newly Identified Health Risks) appointed by the European Commission has produced a report on the safety of metal-on-metal joint replacements (“The safety of Metal-on-Metal joint replacements with a particular focus on hip implants”).
The full text of the report can be downloaded via the following link:
Injectable products for wrinkle treatment
In-vitro diagnostics (IVD)
Creutzfeldt-Jakob tests
Genetic tests
Prohibition to sell tests for Helicobacter pylori to the public
Iris implants
Intraocular iris implants NewIris, NewColorIris and BrightOcular (PDF, 15 kB, 26.10.2011)Non-compliance with Swiss and European regulations on medical devices
Laparoscopic uterine power morcellation (tissue comminution)
Laparoscopic uterine power morcellation (tissue comminution) (PDF, 21 kB, 04.08.2015)Statement by Swissmedic in conjunction with the Study Group for Endoscopic Gynaecology of the SGGG (Swiss Society of Gynaecology and Obstetrics)
Laser and non-laser
Software
Wann ist eine App ein Medizinprodukt?
The FOPH (Federal Office of Public Health) has published within the FOPH magazine „spectra – Prevention and Health Promotion“ of September 2018, supported by Swissmedic, a publication on Apps which are considered as medical devices (in German and French).
Macrolane
Accessories for medical devices