To ensure that you are always up to date, we recommend the following sources and information:
MDR news ticker from Swiss Medtech
Swiss Medtech, the Swiss Medical Technology Association, offers a news ticker on the subject of Medical Device Regulation on its website. This way, you will always stay informed about the latest developments and receive important links and guidance for Swiss manufacturers and distributors of medical devices.
Guidance for Swiss manufacturers
The necessary update of the medical devices chapter is linked by the EU to progress on the institutional agreement. As the Federal Council informed in a press release dated 19 May 2021 (in German), the EU and Switzerland have held intensive discussions on possible transitional provisions for the MRA based on a proposal from the EU Commission. These talks have not yet led to an agreement.
Swiss Medtech offers practical assistance for the third-country scenario:
- Guidance for Swiss manufacturers of medical devices
- Guidance for Swiss sellers of medical devices
- Model contracts for EU and Swiss accredited representatives can be ordered from Angela Daranno (free of charge for Swiss Medtech members, CHF 100 for non-members).
MDR links and document collection
Would you like to find out more about the subject? On its website, Swiss Medtech offers a collection of links, which include links to national authorities, the European Commission and other important documents.
