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News

List of recalls

Publication of safety measures (FSCA)

fsca.swissmedic.ch

Warnings and counterfeits

28.10.2019

UPDATE zur Sicherheitsmitteilung: COCUNE – Waschhandschuh (parfümiert/unparfümiert) der Firma Stöpler Instrumenten & Apparaten B.V. (NL)

21.08.2019

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

Brechen des Handgriffs oder der Armauflagefläche

06.05.2019

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

Call for Experts

Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)

Published on: 30/09/2019

Announcements

12.11.2019

Information from the european environment

The EU commission informed about the status of the implementation of Eudamed

12.09.2019

Events concerning medical devices

Events with speakers from Swissmedic

06.09.2019

Designation of new issuing entity for Unique Device Identifiers (UDI)

in the field of medical devices

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

Updated PDF forms

01.11.2019

BW520_00_001d_VZ Anerkannte KBS für MEP (PDF, 245 kB, 01.11.2019)

04.10.2019

MU510_00_003e_FO MEDDEV Template: Manufacturer’s Incident Report (PDF, 180 kB, 03.10.2019)mandatory as of January 2020

MU510_00_011e_MB Help text new MIR (XLS, 269 kB, 02.10.2019)

23.09.2019

MU510_00_006e_FO MEDDEV Template Periodic Summary Report (PSR) (DOC, 218 kB, 20.09.2019)

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 01.11.2019

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