List of recalls
Warnings and counterfeits
Updated PDF forms
BW530_00_005dfe_FO Form for the registration of information relating to the certification of in vitro diagnostic medical devices (Annexes III to VII) In Vitro Diagnostic Medical Devices 98/79/EC (PDF, 1 MB, 01.02.2018)
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.
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
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
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:
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.