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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

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

10.02.2026

New in swissdamed

“Legacy devices” registration now available

02.02.2026

Significant violations in the use of medical devices for wrinkle treatment (‘fillers’)

The results of this year's focus campaign by the cantonal therapeutic products authorities and Swissmedic clearly demonstrate how important qualified medical professionals and product conformity are for consumer safety.

30.01.2026

Market surveillance of medical devices

Results of a Swissmedic focus campaign of importers

30.01.2026

Version 2.1 of the «Schweizerische Gute Praxis für die Instandhaltung von Medizinprodukten» (GPI)

GPI version 2.0 have been updated to Version 2.1. This revision clearly reflects the requirements set out in Art. 71 para. 2 MedDO and Art. 64 para. 2 IvDO. Details can be found in the document's change history.

12.01.2026

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

On 28 May 2026, Swissmedic is hosting a free online training on how to register medical devices in swissdamed

05.01.2026

ERFA-Tagung Materiovigilance: Gemeinsam für sichere Medizinprodukte

Am 13. Januar 2026 organisieren Swissmedic und H+ gemeinsam die erste ERFA-Tagung zum Thema Materiovigilance

New / updated documents

BW630_40_871e_WL swissdamed Service Agreement (PDF, 314 kB, 27.03.2026)

MU600_00_017e_MB 3D printers medical devices (PDF, 317 kB, 26.03.2026)

MU680_20_009e_WL Incident economic operators (PDF, 343 kB, 26.03.2026)

MU680_21_010e_WL FSCA economic operators (PDF, 300 kB, 26.03.2026)

BW600_00_015e_MB Clinical investigations with medical devices (PDF, 713 kB, 25.03.2026)

MU600_00_018e_MB Systems and procedure packs (PDF, 339 kB, 23.03.2026)

BW617_00_003e_MB Derogation MEP (PDF, 263 kB, 20.03.2026)

MU600_00_006e_MB Procurement of medical devices in health institutions (PDF, 486 kB, 20.03.2026)

MU600_00_007e_MB Products without an intended medical purpose (PDF, 741 kB, 20.03.2026)

MU600_00_016e_MB Obligations Economic Operators CH (PDF, 1 MB, 20.03.2026)

BW610_10_029e_FO Application for fee reduction (PDF, 1 MB, 04.03.2026)

BW630_40_001e_PU swissdamed UDI Data Dictionary (XLSX, 126 kB, 23.02.2026)

BW600_00_016e_MB Performance studies with IVD (PDF, 539 kB, 18.02.2026)

MU680_50_012e_WL Online help for the MD publication service (PDF, 289 kB, 09.02.2026)

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 30.03.2026

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