The countdown for the MDR is on
The European Union (EU) is linking the update of the Mutual Recognition Agreement (MRA) with progress on the Institutional Agreement (InstA). It is now a question of political process whether Switzerland and the EU will agree on an update of the MRA before 26 May 2021; or on a transitional solution whereby the current MRA would continue to apply. The outcome remains uncertain.
As a result, we once again urgently draw the attention of all Swiss manufacturers and distributors of medical devices to the fact that they may have to comply with the requirements of a third country for all medical devices (MDR and MDD) as of 26 May 2021. This essentially involves the appointment of a European Authorized Representative for all medical devices exported to the EU and a Swiss Au-thorized Representative for all medical devices imported into Switzerland.
The decision to adapt to the third-country requirements must be made by each company individually. In our function as an industry association, however, we are available to provide advice and support and would like to offer the following assistance:
Instructions for Swiss Manufacturers (in German)Instructions for Swiss Distributors and Importers
Swiss Medtech represents more than 750 members in its role as industry association for Swiss medical technology. With 67,500 employees and a contribution of 11.5% to the positive trade balance, medical technology is an economically significant sector in Switzerland. Swiss Medtech advocates for conditions that enable the medtech industry to perform at peak capacity and provide first-class medical care.