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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

19.06.2026

New options for registering devices in swissdamed: Online editor, Machine-to-Machine (M2M) interface, and Master UDI-DI registration

Thanks to a user-friendly online editor and a M2M interface, the registration process in the UDI Devices module is simpler, faster, and better adapted to different user needs. The registration of contact lenses that require a Master UDI-DI is now also supported.

18.06.2026

Updated information sheet about the requirements for the maintenance of sterilization containers

The information sheet on the requirements for the maintenance of sterilization containers has been updated and further detailed

01.06.2026

swissdamed Webinar: How to register and manage medical device data in swissdamed

Presentation and recording now available

27.04.2026

Clinical investigations with medical devices

New edition ISO 14155:2026 is available

23.04.2026

Focus campaign 2026 to review post-market surveillance documentation

Swissmedic will be conducting a focus campaign of the requirements for post-market surveillance of higher-risk medical devices

17.04.2026

Sammelmeldungen für in‑house IVD und in‑house MEP ab 1. Januar 2027 nicht mehr möglich

Meldungen gemäss Art. 10 IvDV und Art. 18 MepV sind ab diesem Zeitpunkt ausschliesslich als Einzelmeldungen einzureichen.

30.03.2026

The registration obligation for IVD devices in swissdamed replaces the notification obligation by 1st July 2026

The registration of devices according to Art. 90 IvDO will become mandatory in swissdamed as of July 1, 2026, with a transition period until December 31, 2026.

30.03.2026

The registration obligation for MD-DEVIT devices in swissdamed replaces the notification obligation by 1st July 2026

The registration of MD-DEVIT products according to Art. 108 MedDO will become mandatory in swissdamed as of July 1, 2026, with a transition period until December 31, 2026

30.03.2026

The registration obligation for MD devices in swissdamed replaces the notification obligation by 1st July 2026

The registration of devices, systems, and procedure packs according to Art. 108 MedDO will become mandatory in swissdamed as of July 1, 2026, with a transition period until December 31, 2026

24.03.2026

New guideline «Schweizerische Gute Praxis der Materiovigilance im Spital» (GPMV-Spital)

With the new «Schweizerische Gute Praxis der Materiovigilance im Spital» (GPMV-Spital), Swissmedic is publishing a guideline designed to support hospitals, professionals working there and vigilance contact persons for medical devices in the correct implementation of materiovigilance

20.02.2026

New in the swissdamed playground: Machine-to-Machine product registration

M2M registration can be tested on the swissdamed playground environment starting end of March 2026

New / updated documents

BW630_40_795e_HB swissdamed User Guide Playground (PDF, 1 MB, 19.06.2026)

MU100_00_001e_MB Injectable products for wrinkle treatment (PDF, 300 kB, 19.06.2026)

BW630_40_795e_HB swissdamed User Guide Playground (PDF, 1 MB, 19.06.2026)

BW630_40_001e_PU swissdamed UDI Data Dictionary (XLSX, 128 kB, 19.06.2026)

IN615_30_942d_MB Merkblatt Anforderungen an die Instandhaltung von Sterilcontainern (Sterilisierbehälter nach SN EN 868-8) (PDF, 605 kB, 15.06.2026)

BW630_40_001e_HB Handbook swissdamed User Guide Actors (PDF, 3 MB, 15.06.2026)

IN615_20_002d_CL Checkliste für die Inspektion von Aufbereitungseinheiten für Medizinprodukte (AEMP) (DOCX, 17 MB, 18.05.2026)

BW630_40_841e_HB swissdamed User Guide UDI Devices Module (PDF, 2 MB, 19.06.2026)

MU600_00_006e_MB Procurement of medical devices in health institutions (PDF, 491 kB, 19.05.2026)

MU680_20_017e_FO Manufacturer Incident Report (MIR), V7.3.1 (SB-11154) (PDF, 241 kB, 07.05.2026)

BW600_00_017e_MB Combined studies (PDF, 399 kB, 01.05.2026)

MU680_20_815e_WL Guidance document CH Guide Manufacturer Incident Report (MIR) (PDF, 379 kB, 01.05.2026)

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 19.06.2026

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