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SWISS MEDTECH _ Worst Case scenario still realistic from today’s perspective

Mutual Recognition Agreement (MRA) Switzerland _ Europe versus Third-Country compliance for all products (MDR-MDD) from May 26, 2020 ?

As indicated in the information bulletin from Swiss Medtech dated December 11, 2019, concerning the Mutual Recognition Agreement (MRA), the interpretation of the current MRA is key for Swiss manufacturers.

Since last December, EU Commission lawyers have been interpreting the MRA in the most unfavourable way possible for Switzerland. Their position assumes that the MRA will no longer apply to medical devices after May 26, 2020.

This worst case scenario is realistic from today’s perspective.

Swiss Medtech recommends that Swiss manufacturers consider the technical interpretations of the MRA that the EU commission have made since last December and adjust their business strategy accordingly.

Please not that a last minute political solution is also still conceivable before the May-26-2020 deadline.

from : www.swiss-medtech.ch

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