Medtech industry requires now legal certainty

The Swiss medical technology industry requires legal certainty regarding the 26 May 2021 date of application for the European Medical Devices Ordinance; by the end of November 2020 at the latest. A pragmatic solution to the Mutual Recognition Agreement (MRA) is especially crucial. The association expects the Federal Council to promptly secure either an update of the MRA, or an interim solution whereby the current MRA remains applicable. «The Corona crisis has clearly demonstrated how closely Switzerland and the EU are interconnected and how important the cross-border provision of medical devices for patient care really is. Patient protection remains the overriding interest, and both Switzerland and the EU will benefit from a pragmatic solution to the MRA», says Beat Vonlanthen, President of Swiss Medtech.

For the past two years, the Swiss medtech industry has been forced to alter business plans to meet temporarily or long-term requirements for third countries regarding access to the EU internal market. This has seriously affected the investment climate, customer relations, employee retention, and start-up companies. «It is painful to see how the competitive edge of a previously healthy and innovative Swiss industry sector has been weakened» says Simon Michel, CEO of the Burgdorf-based medtech company Ypsomed and member of the Swiss Medtech Board. «Many decision-makers seem unaware of the extent to which this procrastination has already harmed – and will continue to undermine – Switzerland as a centre of business and research. The current legal limbo is unacceptable and cannot be sustained», says Michel.