S-GE | The new EU Medical Device Regulation (MDR) came into force on 26 May 2021
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Medical devices regulation (MDR): 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. Switzerland Global Enterprise (S-GE) have collected the most important links for you and are providing an initial overview.
New regulations applicable to medical devices as of 26 May 2021
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 (in French) dated 19 May 2021, 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 (in German)for Swiss manufacturers of medical devices
- Guidance (in German) for Swiss sellers of medical devices
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.