There is continuing doubt about the outcome of the Institutional Agreement (InstA) Switzerland negotiated with the EU. Hence, the advice from Switzerland’s Medtech industry association is to begin considering preparing to meet third-country requirements with regards to marketing products in the EU.
It is unclear if Switzerland’s Federal Council will ratify last year’s InstA with the EU so there is no guarantee that Swiss companies will be able to market their products under the EU Regulation 2017/745 on medical devices (MDR) when it takes effect next year.
The mutual recognition agreement (MRA) that is present between Switzerland and the EU has to be updated to continue barrier-free access to the EU single market. But it appears that the MRA can only be updated if the Federal Council gives its backing to the InstA during 2019. If this does not occur, manufacturers will have to employ an Authorised Representative residing in the EU who will assume the manufacturer’s responsibilities, including liability, as a representative. They would also have to modify their product labels accordingly. This could take a considerable amount of time depending on the scope and intricacy of the product range.
Furthermore, Swiss Medtech warns that companies should be informed about aspects that could affect the transitional provisions of the MDR. Exceptions to the MDR could apply if Brexit occurs and there is a Europe-wide supply holdup or if there are not sufficient Notified Bodies to certify products before the end of the transitional period ends in May 2020.
Source: Medtech Insight (an Informa product)