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News

List of recalls

List of FSCAs

fsca.swissmedic.ch

Warnings and counterfeits

17.04.2023

Counterfeit BIO-GEN CORTICAL BONE substitutes from Bioteck S.p.A.

Safety notice

30.05.2022

Latest information on the Field Safety Notice issued by Philips Respironics regarding specific ventilators, sleep apnoea and respiratory care devices

Information on the status of ongoing corrective actions

16.07.2021

Update to Field Safety Notice from Philips Respironics regarding specific ventilators, sleep apnoea and respiratory care devices – recommendations from professional associations

Recommendations of the professional societies SGP and SSSSC published

Announcements

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.

16.05.2024

Clinical trials

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

IN615_20_002d_CL Checkliste für die Inspektion von Aufbereitungseinheiten für Medizinprodukte (AEMP) (PDF, 7 MB, 01.05.2024)

BW630_30_007e_MB Medical Device Software (PDF, 499 kB, 10.04.2024)

BW690_00_002e_WL Export Certificates (PDF, 3 MB, 27.03.2024)

IN640_00_001e_MB Information sheet MDS requirements for corrective and preventive action plans (PDF, 836 kB, 01.02.2024)

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www.swissmedic.ch/md-en

Contact

Swissmedic
Medical devices
Hallerstrasse 7
3012 Berne
Switzerland

General questions about medical devices

Troubleshooting for PDF forms

Last modification 14.05.2024

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