"Worst case scenario" MDR and MDD realistic for third countries?
Swiss Medtech indicated in its last information bulletin, third-country compliance for all products under the MDR and MDD from 26 May 2020 is currently the realistic «worst-case scenario».
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 unfavorable way possible for Switzerland. Their position assumes that the MRA will no longer apply to medical devices after 26 May 2020.
The worst-case scenario – that Swiss manufacturers will have to meet third country requirements for all medical devices (MDR and MDD) from 26 May 2020 – is realistic from today's perspective.
For more information, you can find the latest information bulletin of Swiss Medtech here.