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News

List of recalls

List of FSCAs

fsca.swissmedic.ch

Warnings and counterfeits

09.07.2025

Warning concerning Smileie aligners

Swissmedic recommends that Smileie aligners should henceforth no longer be used

29.04.2025

Counterfeit of the medical device SmartBone®, bone substitute, from lndustrie Biomediche lnsubri SA

Safety notice

Announcements

19.09.2025

swissdamed technical documents

The data dictionary for the swissdamed module UDI Devices has been published

01.09.2025

Swiss Good Practices for the Reprocessing of Flexible, Thermolabile Endoscopes

The Swiss Good Practices for the Reprocessing of Flexible, Thermolabile Endoscopes (GPAE) are here! The central reference document for the reprocessing of flexible endoscopes in inpatient and outpatient healthcare facilities has been published in September 2025. It is now available in German and French.

20.08.2025

Hospital Inspections Annual Report 2024

Legal requirements not fulfilled

18.08.2025

New in swissdamed: Medical device registration now available

With the new UDI Devices module, registering medical devices, including in vitro diagnostic medical devices, in the swissdamed database is now available

08.08.2025

Information sheet systems and procedure packs

The Information sheet outlines the obligations for the assembly and labelling of systems and procedure packs, as well as the associated obligations of economic operators in Switzerland and Liechtenstein

08.08.2025

Implementation in Switzerland of EU Commission Implementing Regulation on instructions for use in electronic form

Swissmedic is adopting the new EU requirements for the electronic provision of instructions for use for medical devices with immediate effect

New / updated documents

BW630_40_001e_PU swissdamed UDI Data Dictionary (XLSX, 122 kB, 18.09.2025)

BW630_40_841e_HB swissdamed User Guide UDI Devices Module (PDF, 1 MB, 15.08.2025)

BW630_40_001e_HB Handbook swissdamed User Guide Actors (PDF, 3 MB, 15.08.2025)

BW630_40_002e_PU swissdamed Business Rules (PDF, 416 kB, 15.08.2025)

BW630_40_808e_PU swissdamed Quick Guide (PDF, 322 kB, 15.08.2025)

BW630_40_809e_PU swissdamed Quick Guide - Registration in the UDI Devices Module (PDF, 215 kB, 15.08.2025)

BW630_40_870e_WL swissdamed Privacy Notice and Terms of Use (PDF, 298 kB, 05.08.2025)

BW630_40_871e_WL swissdamed Service Agreement (PDF, 308 kB, 15.08.2025)

MU600_00_018e_MB Systems and procedure packs (PDF, 379 kB, 04.08.2025)

IN615_20_003d_CL Checkliste für die Inspektion von Aufbereitungseinheiten von flexiblen, thermolabilen Endoskopen (PDF, 1 MB, 01.08.2025)

MU680_20_017e_FO Manufacturer Incident Report (MIR), V7.3.1 (PDF, 229 kB, 21.07.2025)(mandatory from November 2025)

Permanent link of this page
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 25.09.2025

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