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.

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.

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.

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.

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.

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.