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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

10.09.2026

New guideline «Schweizerische Gute Praxis der Materiovigilance in der In-vitro-Diagnostik» (GPMV-IVD)

Swissmedic publishes the new «Schweizerische Gute Praxis der Materiovigilance in der In-vitro-Diagnostik» (GPMV-IVD). This guideline is intended to support professionals using in vitro diagnostic medical devices (IVDs) for medical purposes, as well as persons responsible for the implementation of medical device vigilance in the field of in vitro diagnostics

03.09.2026

swissdamed Webinar 10 November 2026

How to register and manage medical device data in swissdamed

13.08.2026

Swissmedic hospital inspections 2025: supervision having an effect, but action still needed

Positive effect of surveillance visible

17.07.2026

Checklist for the inspection of medical device vigilance in hospitals

This checklist serves as a tool for Swissmedic in the context of its inspection activities in hospitals and may be used by healthcare facilities to carry out gap analyses with regard to the requirements of the GPMV-Spital

01.07.2026

swissdamed: As of 1 July 2026, mandatory registration applies to medical devices and in vitro diagnostic medical devices

New requirements for manufacturers and authorised representatives

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.

New / updated documents

BW690_00_001e_VL FSC - Examples of a Product List as well as a Product List for Systems and Procedure Packs (PDF, 213 kB, 09.09.2026)

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, 07.07.2026)

MU600_00_006e_MB Procurement of medical devices in health institutions (PDF, 556 kB, 11.08.2026)

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 10.09.2026

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