The national association for medical technology companies in Switzerland, Swiss Medtech, has issued a warning to manufacturers of the consequences of the potential failure of the Mutual Recognition Agreement between the EU and Switzerland.
According to Swiss Medtech, since last December the EU lawyers have been interpreting the MRA “in the most unfavourable way for Switzerland”. The consequence of the position being taken would be that from 26 May 2020 the MRA would no longer apply for medical devices. In the worst-case scenario, Swiss manufacturers would have to meet third-country requirements for all medical devices. Swiss Medtech assesses this to be “realistic from today’s perspective”.
The association is advising Swiss manufacturers to consider the Commission’s technical interpretations of the MRA, and to adjust their business strategy accordingly. A last-minute political solution is still possible, however.