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Medical Devices Regulation (MDR) – an overview

What do exporters need to know about the Medical Devices Regulation (MDR)? The date of application is May 26, at the same time as the corresponding Swiss Ordinance on Medical Devices (MedDO) comes into force. We have collected the most important links for you and are providing an initial overview.

medtech

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.

To the news ticker

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.

Do you have any questions?

The ExportHelp team at Switzerland Global Enterprise is the first port of call for Swiss and Liechtenstein SMEs for administrative export-related issues of any kind.

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