Information on specific medical devices

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:

Creutzfeldt-Jakob tests

Disinfectants

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


Genetic tests

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)

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

Macrolane

Accessories for medical devices