Overview medical devices

List of recalls

Warnings and counterfeits

30.07.2017

30.05.2017

News

Updated PDF forms
09.02.2018 

06.02.2018
01.02.2018
01.01.2018

23.01.2018

New information on the EU Regulations (MDR, IVDR)
The European competent authorities have elaborated and published a roadmap for implementing the MDR and IVDR in Europe.
A European working group has published a FAQ document for both the MDR and IVDR.


12.01.2018

20.12.2017

New information on PIP: European SCHEER Report
On 28 September 2017, the European 'Scientific Committee on Health, Environmental and Emerging Risks' (SCHEER) published its report on new scientific information relating to the safety of PIP breast implants: Final advice on PIP


20.12.2017

New information on ALCL: European SCHEER Report
On 19 October 2017, the European 'Scientific Committee on Health, Environmental and Emerging Risks' (SCHEER) published its report on the state of scientific knowledge on a possible connection between breast implants and ALCL: Final advice on BI-ALCL


28.11.2017

The procedure for making submissions has been revised. The completed form and attachments now have to be submitted in electronic format via the Swissmedic’s “emessage” portal. Further information:


23.11.2017

Entry into force of the early revision of the Medical Devices Ordinance (MedDO): 26 November 2017
Now that the first articles of the new EU regulations (MDR and IVDR) have come into effect, the Medical Devices Ordinance has also been revised.


30.06.2017

Contact

Swissmedic
Division medical devices
Hallerstrasse 7
P.O. Box
CH-3000 Berne 9

Print contact

https://www.swissmedic.ch/content/swissmedic/en/home/medical-devices/overview-medical-devices.html