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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

23.12.2025

Deadline for Device Registration in swissdamed

The registration of devices, systems, and procedure packs will become mandatory in swissdamed as of July 1, 2026, with a transition period until December 31, 2026

27.11.2025

swissdamed Playground

The playground for the swissdamed UDI Devices module is now available

21.10.2025

Applicable EU legal acts

Section updated to reflect recent delegated regulations and reorganised to clarify the mechanisms

01.10.2025

swissdamed UDI Devices module

The discard functionality is now available in the UDI Devices module of swissdamed

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.

New / updated documents

MU680_20_017e_FO Manufacturer Incident Report (MIR), V7.3.1 (SB-10781) (PDF, 241 kB, 22.12.2025)

BW690_00_001defi_FO Orders for export certificates for medical devices (PDF, 1 MB, 01.12.2025)

BW690_00_002e_WL Export Certificates (PDF, 523 kB, 11.12.2025)

BW630_40_795e_HB swissdamed User Guide Playground (PDF, 1 MB, 27.11.2025)

BW630_40_871e_WL swissdamed Service Agreement (PDF, 289 kB, 25.11.2025)

BW690_00_001e_VL FSC - Examples of a Product List as well as a Product List for Systems and Procedure Packs (PDF, 249 kB, 24.11.2025)

MU680_20_815e_WL Guidance document CH Guide Manufacturer Incident Report (MIR) (PDF, 360 kB, 20.11.2025)

BW610_20_022e_FO Notification of safety measures MD IVD (PDF, 1 MB, 20.11.2025)

BW610_20_023e_FO SAE-CH and DD-CH MD (PDF, 1 MB, 20.11.2025)

BW610_20_024e_FO SAE-CH and DD-CH IVD (PDF, 1 MB, 20.11.2025)

BW610_20_026e_FO Notifications of safety measures combined studies (PDF, 1 MB, 20.11.2025)

BW610_20_021e_FO Modifications, notifications, reports MD IVD (PDF, 1 MB, 18.11.2025)

BW610_20_025e_FO Form Modifications, notifications, reports MD IVD (PDF, 1 MB, 18.11.2025)

BW690_00_001e_WL Service Agreement Export Certificates MEP (PDF, 250 kB, 13.11.2025)

BW690_00_002defi_FO Orders for export certificates for medical devices subject to old legislation and IVD (PDF, 1 MB, 03.04.2025)

MU600_00_018e_MB Systems and procedure packs (PDF, 369 kB, 31.10.2025)

BW610_10_021e_FO Application clinical investigation MD (PDF, 1 MB, 30.10.2025)

BW610_10_022e_FO Clinical trials of research sequences on CE-marked MRI systems (PDF, 1 MB, 30.10.2025)

BW610_10_023e_FO Application simplified review MD (PDF, 1 MB, 30.10.2025)

BW610_10_024e_FO Application performance study IVD (PDF, 2 MB, 30.10.2025)

BW610_10_025e_FO Application simplified review IVD (PDF, 1 MB, 30.10.2025)

BW610_10_026e_FO Application combined study MP / ATMP and MD (PDF, 2 MB, 30.10.2025)

BW610_10_027e_FO Application combined study MP / ATMP and IVD (PDF, 2 MB, 30.10.2025)

BW610_10_028e_FO Application Confidentiality Restrictions (PDF, 1 MB, 30.10.2025)

BW610_10_029e_FO Application for fee reduction (PDF, 1 MB, 30.10.2025)

BW600_00_017e_MB Combined studies (PDF, 452 kB, 27.10.2025)

BW630_40_841e_HB swissdamed User Guide UDI Devices Module (PDF, 1 MB, 01.10.2025)

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 29.12.2025

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