NEWS

MDR amendments are now legally binding

Regulation (EU) 2023/607 of 15 March 2023 was published today in the Official Journal of the EU and enters into force with immediate effect. The final signed text is available in all EU languages and can be found here.

Swiss Medtech 2022 Annual Report

In addition to dealing with day-to-day business and the complex challenges posed by the on-going political and regulatory situation, the Swiss Medtech Board and Executive Committee have also been planning the association’s future course in the form of the «Medtech in Switzerland 2030» strategy project.

Motion 20.3211

Foreign countries are very interested in Switzerland’s path towards recognising medical devices with FDA approval in the future. Sandra Rickenbacher-Läuchli was a guest speaker at the MassMEDIC webinar and will reported on the motion 20.3211 by Council of States member Damian Müller.

ARD Plusminus Film

The film illustrates the negative consequences of MDR on patient care. Another disturbing trend: innovation is migrating. Many manufacturers are choosing to have their medical devices approved in the USA first. This is where Switzerland and the motion 20.3211 by Councillor of States Damian Müller come into play in the film.

firstbase healthcare

Just imagine: In the future you only have to record your medical device master data on one central database. The data exchange platform firstbase healthcare, created by GS1 Switzerland, offers precisely this service. Swiss Medtech, H+, and refdata are all active partners.

Application of MDCG 2022-18 in Switzerland

EU Position Paper MDCG 2022-18 describes a transitional solution for dealing with certification gaps. Confirmations («written communications») from the responsible European medical devices authorities stating that they have granted a period of grace under MDCG 2022-18 will be accepted unilaterally in Switzerland. 

Event Calendar

iCal 2023-03-30 02:00:00 2023-03-30 02:00:00 MDR@noon, MDSRO: Meldestelle für fehlende Medizinprodukte MDSRO: Meldestelle für fehlende Medizinprodukte https://www.swiss-medtech.ch/node/10 HWZ Hochschule für Wirtschaft Zürich Lagerstrasse 5 0000 online (Englisch) Switzerland Swiss Medtech https://www.swiss-medtech.ch Europe/Zurich public
iCal 2023-04-04 02:00:00 2023-04-04 02:00:00 Experience Day, Wozu brauche ich eine Klimabilanz und wie mach ich das? Wozu brauche ich eine Klimabilanz und wie mach ich das? https://www.swiss-medtech.ch/node/10 HWZ Hochschule für Wirtschaft Zürich Lagerstrasse 5 8021 Zürich Switzerland Swiss Medtech https://www.swiss-medtech.ch Europe/Zurich public
iCal 2023-04-26 02:00:00 2023-04-26 02:00:00 BSCC Life Sciences Programme | The Future of the Swiss and UK Medtech Industry in Europe BSCC Life Sciences Programme | The Future of the Swiss and UK Medtech Industry in Europe https://www.swiss-medtech.ch/node/10 online 0000 online Switzerland Swiss Medtech https://www.swiss-medtech.ch Europe/Zurich public
iCal 2023-04-26 02:00:00 2023-04-27 02:00:00 Europäischer Kongress Orthomanufacture 2023 Europäischer Kongress Orthomanufacture 2023 https://www.swiss-medtech.ch/node/10 Kongresszentrum Beaulieu 1004 Lausanne Switzerland Swiss Medtech https://www.swiss-medtech.ch Europe/Zurich public
iCal 2023-05-23 02:00:00 2023-05-25 02:00:00 MedtecLIVE with T4M, Swiss Pavilion MedtecLIVE with T4M https://www.swiss-medtech.ch/en/node/10 Messe Nürnberg 90471 Nürnberg Germany Swiss Medtech https://www.swiss-medtech.ch Europe/Zurich public
iCal 2023-05-25 02:00:00 2023-05-25 02:00:00 Swiss Medtech Mitgliederversammlung 2023 Die Swiss Medtech Mitgliederversammlung ist exklusiv für Mitarbeitende von Swiss Medtech Mitgliedsfirmen. Im Vorfeld der Swiss Medtech Mitgliederversammlung finden Versammlungen der Fachgruppen statt. https://www.swiss-medtech.ch/node/10 Swiss Medtech Freiburgstrasse 3 4051 Basel Switzerland Swiss Medtech https://www.swiss-medtech.ch Europe/Zurich public