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Information on specific medical devices

Product groups without an intended medical purpose in accordance with Annex 1 MedDO

Publications on products specified in Annex 1 MedDO with a medical or non-medical intended purpose, i.e. including dual-use products (e.g. breast implants or injectable products for wrinkle treatment), can be found in the new section on product groups without an intended medical purpose:

Publications on product groups without an intended medical purpose

1.11.2023

Rapid tests for SARS-CoV-2 to the general public for their own use (coronavirus self-tests)

01.07.2024

Expiry of COVID-19 Ordinance 3

Dispensing of coronavirus self-tests still possible from 1 July 2024

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)

Updated information on BIA-ALCL

20.12.2024

Pelvic floor meshes and slings

Withdrawal of products indicated for transvaginal placement of pelvic organ prolapse produced by Boston Scientific Corporation

06.05.2019

Discontinuation of sale of mesh produced by C.R. Bard, Inc. for pelvic organ prolapse and stress urinary incontinence, and its removal from hospitals and distribution centres

01.04.2019

Pelvic floor meshes and slings – Reference to expert letters sent by the SGGG (Swiss Society of Gynaecology and Obstetrics)

18.02.2019

3D printers and medical device legislation

MU600_00_017e_MB 3D printers medical devices (PDF, 314 kB, 13.08.2024)

Compressed air, pressure vessels, pressure equipment

Medical devices and pressure equipment regulations – SVTI Leaflets

Hypothermia devices (heater cooler units)

08.02.2017
We would like to inform you about new directives on the operation and the surveillance of hypothermia devices (Heater-Cooler Devices / Units) in the operation room:

Richtlinien zum Betrieb und zur Überwachung von Heater-Cooler Devices (HCDs) im Operationssaal (PDF, 344 kB, 27.01.2017)

Link to the information from the FOPH (in German):

Healthcare-assoziierte Infektionen

In-vitro diagnostics (IVD)

HIV self-test kits now also available in Switzerland

Paclitaxel-coated balloons and paclitaxel-eluting stents

Update: Paclitaxel-coated balloons and paclitaxel-eluting stents: Potential association with increased mortality not confirmed

15.04.2024

UPDATE: Treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents: Potential association with increased mortality

24.06.2020

UPDATE: Treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents: Potential association with increased mortality

08.07.2019

Treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents: Potential association with increased mortality

16.04.2019

Software

Wann ist eine App ein Medizinprodukt?

The FOPH (Federal Office of Public Health) has published within the FOPH magazine „spectra – Prevention and Health Promotion“ of September 2018, supported by Swissmedic, a publication on Apps which are considered as medical devices (in German and French).

BW630_30_007e_MB Medical Device Software (PDF, 499 kB, 10.04.2024)

Accessories for medical devices

Medizinprodukte, die nicht unter Körperberührung verwendet werden: Schnittstellen zum Chemikalienrecht (PDF, 221 kB, 25.09.2013)

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