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News

List of recalls

Publication of safety measures (FSCA)

fsca.swissmedic.ch

Warnings and counterfeits

21.08.2019

Sicherheitsmitteilung: Rückruf von Unterarmgehstützen des Modells ADVANCE – Herdegen Paris, Chelles

Brechen des Handgriffs oder der Armauflagefläche

25.06.2019

Safety Notice: COCUNE – wash gloves (perfumed/non-perfumed) from Stöpler Instrumenten & Apparaten B.V.

Possible contamination with bacteria - precautionary measure: do not use products until further notice

06.05.2019

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

Announcements

02.08.2019

Single Registration Number (SRN)

A collection of the most common questions and answers concerning the Single Registration Number (SRN) can be found in the following FAQ.

31.07.2019

Update on MEDDEV 2.12/1 rev. 8

In July 2019 the EU Commission supplied an additional guidance document regarding MEDDEV 2.12/1 rev. 8 "Guidelines on a medical devices vigilance system".

18.07.2019

European Factsheet for healthcare professionals and health institutions based on the new Regulation (EU) 2017/745 on medical devices and on the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices

18.07.2019

EU Commission/MDCG Factsheets for manufacturers of medical devices and IVDs

08.07.2019

Update: Treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents

29.05.2019

Events concerning medical devices

Events with speakers from Swissmedic

Updated PDF forms

07.08.2019

MU510_00_009e_MB Medical devices FAQs Patients (PDF, 357 kB, 01.08.2019)

20.06.2019

BW510_00_005e_FO Clinical Trials with medical devices Application for authorisation (PDF, 1 MB, 20.06.2019)

30.04.2019

BW510_00_003e_FO Clinical trials of research sequences on CE-marked MRI systems (PDF, 1 MB, 30.04.2019)

BW510_00_004e_FO Clinical Trials with medical devices: Submission for approved trial (PDF, 1 MB, 30.04.2019)

BW510_00_006e_FO Clinical trials of medical devices: Serious adverse events and deficiencies in Switzerland (PDF, 1 MB, 30.04.2019)

Permanent link of this page
www.swissmedic.ch/md-en

Contact

Swissmedic
Division medical devices
Hallerstrasse 7
3012 Berne
Switzerland

General questions about medical devices

Troubleshooting for PDF forms

Last modification 07.08.2019

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