News


List of recalls



Warnings and counterfeits



Announcements


07.06.2024

New implementing regulations apply as of 1 November 2024

The Federal Council approved the amendments to the ordinances relating to the Human Research Act (HRA) and adopted them on 7 June 2024.

16.05.2024

Announcements on performance studies with vitro diagnostic medical devices

MDCG 2024-04 – New guidance document and table for safety reporting during performance studies.

15.04.2024

Paclitaxel-coated balloons and paclitaxel-eluting stents

Potential association with increased mortality not confirmed

08.02.2024

swissdamed – Swiss Database on Medical Devices

The “going-live” date being deferred to the 2nd half of 2024

29.01.2024

Checkliste zur Überprüfung eines Berichts zur Revalidierung eines Reinigungs- und Desinfektionsprozesses mit RDG für chirurgische Instrumente oder einer Grossraum-Waschanlage (CWA) in Gesundheitseinrichtunge

This checklist (only in German and French) serves as an aid for professionals who check the annual validation reports of instrument washer disinfectors and trolley washer disinfectors.

09.01.2024

Medical devices with certification from the former notified body ECM (Aachen DE, identification number 0481)

Information and targeted check of Swiss authorised representatives

New / updated documents


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www.swissmedic.ch/md-en

Contact

Swissmedic
Medical devices
Hallerstrasse 7
3012 Berne
Switzerland


Last modification 28.05.2024

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