Medical devices: New challenges

To enable free market access for medical devices, the European Union and Switzerland have concluded an agreement on mutual recognition in relation to conformity assessment (MRA). Relying on this agreement, Switzerland has revised its medical device legislation and harmonized it with the legal developments of the European Union. In doing so, Switzerland assumed that medical devices would be granted mutual market access to the same extent as before. Now, however, this assurance no longer seems certain. The EU Commission is making the maintenance of the status quo dependent on concluding a comprehensive institutional framework agreement. Talks on this point threaten to fail.

As a consequence of the European Union's new medical device regulation and the lack of an update of the MRA with Switzerland, both domestic and foreign companies must prepare for the situation whereby medical devices will no longer be guaranteed unconditional market access after 26 May 2021, or 26 May 2022, specifically for diagnostic devices. As Switzerland intends to bring its revised medical device legislation into force at the same time, the import and export of medical devices from and to Switzerland will be subjected to an elaborate additional administrative burden. Industry experts fear that this onerous process will jeopardize the availability of many medical devices.