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:
26.05.2022
Federal Office of Public Health (FOPH) lists the certified self-tests
23.09.2021
COVID-19 pandemic – Reports concerning Sars-CoV-2 rapid tests
Swissmedic takes action against dispensing of non-compliant rapid tests by Swiss online shops
29.06.2020
Exemptions for non-conforming medical devices
01.05.2020
Gesetzliche Rahmenbedingungen zur COVID-19 Testung in der Schweiz
Bedingungen zur Durchführung von COVID-19 Tests in der Schweiz
15.03.2016
12.10.2015
25.03.2015
24.09.2015
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)
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:
14.07.2014
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:
24.06.2013
Creutzfeldt-Jakob tests
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
Prohibition to sell tests for Helicobacter pylori to the public
Please note that documents represented the latest scientific and technical findings as well as the applicable legal requirements at the moment of their publication. After being published on the News and Information on specific medical devices webpages, these documents are then moved to the archives after an appropriate amount of time, where they remain available for information purposes. However, archived documents are no longer updated. The current legislation and the latest scientific and technical findings are always authoritative.
Last modification 01.07.2024